diff --git a/GetStatistics.R b/GetStatistics.R index 1f9acd6..b2cc1a0 100644 --- a/GetStatistics.R +++ b/GetStatistics.R @@ -1,593 +1,283 @@ -################################################################################ -# GetStatistics.R -# 5 Functions: Obtain statistics for further TLG outputs. -################################################################################ - -### Hazard Ratio (Cox's Proportional Hazards Model) ---------------------------- -GetStatistics_HazardR <- function(data, ser, drug, period, residual, soc, - treatment1, treatment2) { - - if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} - - TDDT <- Sys.Date() # use today's date for convenience - - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% - drop_na(RFSTDTC) %>% - mutate(STARTDT = RFSTDTC) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) - } - - data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) - - if (nrow(data) == 0) {return(NULL)} - - data.extend <- NULL - if (soc == FALSE) { - ae.list <- na.omit(unique(data$AEDECOD)) - } else { - ae.list <- na.omit(unique(data$AEBODSYS)) - } - - for (ae in ae.list) { - - events <- data %>% - {if (soc == FALSE) filter(., AEDECOD == ae) else .} %>% - {if (soc == TRUE) filter(., AEBODSYS == ae) else .} %>% - mutate(CNSR = 0) - - if (soc == FALSE) { - aebodsys <- unique(events$AEBODSYS) - } else {} - - censors <- data %>% - filter(!(USUBJID %in% events$USUBJID)) %>% - mutate(CNSR = 1) %>% - group_by(USUBJID) %>% - summarise_all(list(first)) %>% - {if (soc == FALSE) mutate(., - AEDECOD = ae, - AEBODSYS = aebodsys) else .} %>% - {if (soc == TRUE) mutate(., AEBODSYS = ae) else .} %>% - mutate(AESEQ = NA, AESTDT = NA, AESTDY = NA, - AEENDT = NA, AEENDY = NA, AETERM = NA, - AESER = NA, AEONGO = NA, AESEV = NA, - AEREL = NA, AEOUT = NA, STUDYFL = NA, TRTEMFL = NA) %>% - {if (soc == TRUE) mutate(., AEDECOD = NA) else .} - - extension <- rbind(events, censors) %>% - group_by(USUBJID) %>% - mutate(ADT = ifelse(CNSR == 1, min(RFENDTC + 30, TDDT), NA)) %>% - rowwise() %>% - mutate(ADT = ifelse(CNSR == 0, min(AESTDT, na.rm = TRUE), ADT)) %>% - mutate(ADT = as.Date(ADT, origin = "1970-01-01")) %>% - ungroup() %>% - mutate(AVAL = ADT - STARTDT + 1) %>% - distinct() - - data.extend <- rbind(data.extend, extension) - } - - data.extend <- data.extend %>% - mutate(TRT = ifelse(ARMCD %in% treatment1, 1, 0)) - - getHazardRatio <- function(time, delta, trt) { - fit <- coxph(Surv(time, delta) ~ trt) - S <- summary(fit) - - HR <- unname(exp(fit$coefficients)) - HRP <- S$coefficients[5] - - output <- c(HR, HRP) - return(output) - } - - result <- data.extend %>% - mutate(AVAL = as.numeric(AVAL)) %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - RESULT = paste(getHazardRatio(AVAL, CNSR, TRT), - collapse = " ")) else .} %>% - {if (soc == TRUE) summarise(., - RESULT = paste(getHazardRatio(AVAL, CNSR, TRT), - collapse = " ")) else .} %>% - rowwise() %>% - mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), - TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% - select(-RESULT) %>% - mutate(LOGPTEST = -log(TESTP)) - - return(result) -} - - -### Rate Difference (Large Sample Approximation by CLT) ------------------------ -GetStatistics_RateD <- function(data, ser, drug, period, residual, soc, - treatment1, treatment2) { - - if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} - - TDDT <- Sys.Date() # use today's date for convenience - - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% - drop_na(RFSTDTC) %>% - mutate(STARTDT = RFSTDTC) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) - } - - data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) - - if (nrow(data) == 0) {return(NULL)} - - data.extend <- NULL - if (soc == FALSE) { - ae.list <- na.omit(unique(data$AEDECOD)) - } else { - ae.list <- na.omit(unique(data$AEBODSYS)) - } - - for (ae in ae.list) { - - events <- data %>% - {if (soc == FALSE) filter(., AEDECOD == ae) else .} %>% - {if (soc == TRUE) filter(., AEBODSYS == ae) else .} %>% - mutate(CNSR = 0) - - if (soc == FALSE) { - aebodsys <- unique(events$AEBODSYS) - } else {} - - censors <- data %>% - filter(!(USUBJID %in% events$USUBJID)) %>% - mutate(CNSR = 1) %>% - group_by(USUBJID) %>% - summarise_all(list(first)) %>% - {if (soc == FALSE) mutate(., - AEDECOD = ae, - AEBODSYS = aebodsys) else .} %>% - {if (soc == TRUE) mutate(., AEBODSYS = ae) else .} %>% - mutate(AESEQ = NA, AESTDT = NA, AESTDY = NA, - AEENDT = NA, AEENDY = NA, AETERM = NA, - AESER = NA, AEONGO = NA, AESEV = NA, - AEREL = NA, AEOUT = NA, STUDYFL = NA, TRTEMFL = NA) %>% - {if (soc == TRUE) mutate(., AEDECOD = NA) else .} - - extension <- rbind(events, censors) %>% - group_by(USUBJID) %>% - mutate(ADT = ifelse(CNSR == 1, min(RFENDTC + 30, TDDT), NA)) %>% - rowwise() %>% - mutate(ADT = ifelse(CNSR == 0, min(AESTDT, na.rm = TRUE), ADT)) %>% - mutate(ADT = as.Date(ADT, origin = "1970-01-01")) %>% - ungroup() %>% - mutate(AVAL = ADT - STARTDT + 1) %>% - distinct() - - data.extend <- rbind(data.extend, extension) - } - - data.extend.summary <- data.extend %>% - mutate(AVAL = as.numeric(AVAL)) %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), - SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} %>% - {if (soc == TRUE) summarise(., - SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), - SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} - - data.summary <- data %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - distinct(USUBJID, .keep_all = TRUE) %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - {if (soc == TRUE) summarise(., - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - na.omit() - - getRateDifference <- function(count1, count2, saval1, saval2) { - r <- ratedifference(a = count1, b = count2, PT1 = saval1, PT0 = saval2) - RD <- r$estimate - RDP <- r$p.value - - output <- c(RD, RDP) - return(output) - } - - result <- cbind(data.summary, data.extend.summary %>% select(SAVAL1, SAVAL2)) %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - RESULT = paste(getRateDifference(COUNT1, COUNT2, SAVAL1, SAVAL2), - collapse = " ")) else .} %>% - {if (soc == TRUE) summarise(., - RESULT = paste(getRateDifference(COUNT1, COUNT2, SAVAL1, SAVAL2), - collapse = " ")) else .} %>% - rowwise() %>% - mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), - TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% - select(-RESULT) %>% - mutate(LOGPTEST = -log(TESTP)) - - return(result) -} - - -### Rate Ratio (Large Sample Approximation by CLT) ----------------------------- -GetStatistics_RateR <- function(data, ser, drug, period, residual, soc, - treatment1, treatment2) { - - if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} - - TDDT <- Sys.Date() # use today's date for convenience - - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% - drop_na(RFSTDTC) %>% - mutate(STARTDT = RFSTDTC) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) - } - - data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) - - if (nrow(data) == 0) {return(NULL)} - - data.extend <- NULL - if (soc == FALSE) { - ae.list <- na.omit(unique(data$AEDECOD)) - } else { - ae.list <- na.omit(unique(data$AEBODSYS)) - } - - for (ae in ae.list) { - - events <- data %>% - {if (soc == FALSE) filter(., AEDECOD == ae) else .} %>% - {if (soc == TRUE) filter(., AEBODSYS == ae) else .} %>% - mutate(CNSR = 0) - - if (soc == FALSE) { - aebodsys <- unique(events$AEBODSYS) - } else {} - - censors <- data %>% - filter(!(USUBJID %in% events$USUBJID)) %>% - mutate(CNSR = 1) %>% - group_by(USUBJID) %>% - summarise_all(list(first)) %>% - {if (soc == FALSE) mutate(., - AEDECOD = ae, - AEBODSYS = aebodsys) else .} %>% - {if (soc == TRUE) mutate(., AEBODSYS = ae) else .} %>% - mutate(AESEQ = NA, AESTDT = NA, AESTDY = NA, - AEENDT = NA, AEENDY = NA, AETERM = NA, - AESER = NA, AEONGO = NA, AESEV = NA, - AEREL = NA, AEOUT = NA, STUDYFL = NA, TRTEMFL = NA) %>% - {if (soc == TRUE) mutate(., AEDECOD = NA) else .} - - extension <- rbind(events, censors) %>% - group_by(USUBJID) %>% - mutate(ADT = ifelse(CNSR == 1, min(RFENDTC + 30, TDDT), NA)) %>% - rowwise() %>% - mutate(ADT = ifelse(CNSR == 0, min(AESTDT, na.rm = TRUE), ADT)) %>% - mutate(ADT = as.Date(ADT, origin = "1970-01-01")) %>% - ungroup() %>% - mutate(AVAL = ADT - STARTDT + 1) %>% - distinct() - - data.extend <- rbind(data.extend, extension) - } - - data.extend.summary <- data.extend %>% - mutate(AVAL = as.numeric(AVAL)) %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), - SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} %>% - {if (soc == TRUE) summarise(., - SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), - SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} - - data.summary <- data %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - distinct(USUBJID, .keep_all = TRUE) %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - {if (soc == TRUE) summarise(., - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - na.omit() - - getRateRatio <- function(count1, count2, saval1, saval2) { - r <- rateratio(a = count1, b = count2, PT1 = saval1, PT0 = saval2) - RR <- r$estimate - RRP <- r$p.value - - output <- c(RR, RRP) - return(output) - } - - result <- cbind(data.summary, data.extend.summary %>% select(SAVAL1, SAVAL2)) %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - RESULT = paste(getRateRatio(COUNT1, COUNT2, SAVAL1, SAVAL2), - collapse = " ")) else .} %>% - {if (soc == TRUE) summarise(., - RESULT = paste(getRateRatio(COUNT1, COUNT2, SAVAL1, SAVAL2), - collapse = " ")) else .} %>% - rowwise() %>% - mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), - TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% - select(-RESULT) %>% - mutate(LOGPTEST = -log(TESTP)) - - return(result) -} - - -### Risk Difference (Large Sample Approximation by CLT) ------------------------ -GetStatistics_RiskD <- function(data, ser, drug, period, residual, soc, - treatment1, treatment2) { - - if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} - - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% - drop_na(RFSTDTC) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - N1.total <- data %>% - filter(ARMCD %in% treatment1) %>% distinct(USUBJID) %>% - tally() %>% as.numeric() - - N2.total <- data %>% - filter(ARMCD %in% treatment2) %>% distinct(USUBJID) %>% - tally() %>% as.numeric() - - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) - } - - data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) - - if (nrow(data) == 0) {return(NULL)} - - data.summary <- data %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - distinct(USUBJID, .keep_all = TRUE) %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - {if (soc == TRUE) summarise(., - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} - - getRiskDifference <- function(count1, count2) { - r <- riskdifference(a = count1, b = count2, N1 = N1.total, N0 = N2.total) - RD <- r$estimate - RDP <- r$p.value - - output <- c(RD, RDP) - return(output) - } - - result <- data.summary %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - RESULT = paste(getRiskDifference(COUNT1, COUNT2), - collapse = " ")) else .} %>% - {if (soc == TRUE) summarise(., - RESULT = paste(getRiskDifference(COUNT1, COUNT2), - collapse = " ")) else .} %>% - rowwise() %>% - mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), - TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% - select(-RESULT) %>% - mutate(LOGPTEST = -log(TESTP)) - - return(result) -} - - -### Risk Ratio (Large Sample Approximation by CLT) ----------------------------- -GetStatistics_RiskR <- function(data, ser, drug, period, residual, soc, - treatment1, treatment2) { - - if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} - - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% - drop_na(RFSTDTC) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - N1.total <- data %>% - filter(ARMCD %in% treatment1) %>% distinct(USUBJID) %>% - tally() %>% as.numeric() - - N2.total <- data %>% - filter(ARMCD %in% treatment2) %>% distinct(USUBJID) %>% - tally() %>% as.numeric() - - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) - } - - data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) - - if (nrow(data) == 0) {return(NULL)} - - data.summary <- data %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - distinct(USUBJID, .keep_all = TRUE) %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% - {if (soc == TRUE) summarise(., - COUNT1 = sum(ARMCD %in% treatment1), - COUNT2 = sum(ARMCD %in% treatment2)) else .} - - getRiskRatio <- function(count1, count2) { - r <- riskratio(X = count1, Y = count2, m1 = N1.total, m2 = N2.total) - RR <- r$estimate - RRP <- r$p.value - - output <- c(RR, RRP) - return(output) - } - - result <- data.summary %>% - {if (soc == FALSE) group_by(., AEDECOD) else .} %>% - {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% - {if (soc == FALSE) summarise(., - AEBODSYS = first(AEBODSYS), - RESULT = paste(getRiskRatio(COUNT1, COUNT2), - collapse = " ")) else .} %>% - {if (soc == TRUE) summarise(., - RESULT = paste(getRiskRatio(COUNT1, COUNT2), - collapse = " ")) else .} %>% - rowwise() %>% - mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), - TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% - select(-RESULT) %>% - mutate(LOGPTEST = -log(TESTP)) - - return(result) -} - - +################################################################################ +# GetStatistics.R +# 5 Functions: Obtain statistics for further TLG outputs. +################################################################################ + + +GetStatistics_all = function(data, ae_filter, period, residual, soc, treatment1, treatment2, test) { + + if (is.null(treatment1) | is.null(treatment2)) {return(NULL)} + + TDDT <- Sys.Date() # use today's date for convenience + + data <- data %>% + mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY","AGE", "RFENDY", "SAFFN"))], ~as.character(.)) %>% + mutate_at(names(data), ~na_if(., "")) %>% + mutate_at(c("AESTDT", "AEENDT", "RFSTDTC", "RFENDTC"), ~as.Date(.)) %>% + drop_na(RFSTDTC) %>% + mutate(STARTDT = RFSTDTC, + AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD), + AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) + + + ## DOESN'T CALCULATION OF N HAVE TO GO AFTER FILTERS??? + if (test%in% c("Risk Ratio","Risk Difference")){ + N1.total <- length(unique((data %>% filter(ARMCD %in% treatment1))$USUBJID)) + N2.total <- length(unique((data %>% filter(ARMCD %in% treatment2))$USUBJID)) + } + + + # filter data for seriousness, drug-related, and severity + if (length(ae_filter)>0){ + if ("Serious" %in% ae_filter) { data <- data %>% filter(AESER == "Y") } + if ("Drug-related" %in% ae_filter) { data <- data %>% filter(AEREL == "Y") } + if (sum(c("Mild","Moderate","Severe") %in% ae_filter)>0){ + severity_filter = ae_filter[which(ae_filter%in% c("Mild","Moderate","Severe"))] + data = data %>% filter(AESEV %in% severity_filter) + } + } + + # filter data for ae timeframe + if (period == "Treatment emergent") { data <- data %>% filter(TRTEMFL == "Y") } + else if (period == "AE during entire study") { data <- data %>% filter(STUDYFL == "Y") } + else if (period == "Other") { data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) } + + data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) + + if (nrow(data) == 0) {return(NULL)} + + data.extend <- NULL + if (soc == FALSE) { + ae.list <- na.omit(unique(data$AEDECOD)) + } else { + ae.list <- na.omit(unique(data$AEBODSYS)) + } + + for (ae in ae.list) { + + events <- data %>% + {if (soc == FALSE) filter(., AEDECOD == ae) else .} %>% + {if (soc == TRUE) filter(., AEBODSYS == ae) else .} %>% + mutate(CNSR = 0) + + if (soc == FALSE) {aebodsys <- unique(events$AEBODSYS)} + + censors <- data %>% + filter(!(USUBJID %in% events$USUBJID)) %>% + mutate(CNSR = 1) %>% + group_by(USUBJID) %>% + summarise_all(list(first)) %>% + {if (soc == FALSE) mutate(., + AEDECOD = ae, + AEBODSYS = aebodsys) else .} %>% + {if (soc == TRUE) mutate(., AEBODSYS = ae) else .} %>% + mutate(AESEQ = NA, AESTDT = NA, AESTDY = NA, + AEENDT = NA, AEENDY = NA, AETERM = NA, + AESER = NA, AEONGO = NA, AESEV = NA, + AEREL = NA, AEOUT = NA, STUDYFL = NA, TRTEMFL = NA) %>% + {if (soc == TRUE) mutate(., AEDECOD = NA) else .} + + extension <- bind_rows(events, censors) %>% + group_by(USUBJID) %>% + mutate(ADT = ifelse(CNSR == 1, min(RFENDTC + 30, TDDT), NA)) %>% + rowwise() %>% + mutate(ADT = ifelse(CNSR == 0, min(AESTDT, na.rm = TRUE), ADT)) %>% + mutate(ADT = as.Date(ADT, origin = "1970-01-01")) %>% + ungroup() %>% + mutate(AVAL = ADT - STARTDT + 1) %>% + distinct() + + data.extend <- bind_rows(data.extend, extension) + } + + data.extend <- data.extend %>% mutate(TRT = ifelse(ARMCD %in% treatment1, 1, 0)) + + + + if (test %in% c("Rate Difference", "Rate Ratio")){ + data.extend.summary <- data.extend %>% + mutate(AVAL = as.numeric(AVAL)) %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), + SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} %>% + {if (soc == TRUE) summarise(., + SAVAL1 = sum((ARMCD %in% treatment1) * AVAL), + SAVAL2 = sum((ARMCD %in% treatment2) * AVAL)) else .} + } + + + if (test %in% c("Rate Difference", "Rate Ratio","Risk Difference","Risk Ratio")){ + data.summary <- data %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + distinct(USUBJID, .keep_all = TRUE) %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + COUNT1 = sum(ARMCD %in% treatment1), + COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% + {if (soc == TRUE) summarise(., + COUNT1 = sum(ARMCD %in% treatment1), + COUNT2 = sum(ARMCD %in% treatment2)) else .} %>% + na.omit() + } + + + + ### Hazard Ratio (Cox's Proportional Hazards Model) ---------------------------- + if (test=="Hazard Ratio"){ + getHazardRatio <- function(time, delta, trt) { + fit <- coxph(Surv(time, delta) ~ trt) + S <- summary(fit) + + HR <- unname(exp(fit$coefficients)) + HRP <- S$coefficients[5] + + output <- c(HR, HRP) + return(output) + } + + result <- data.extend %>% + mutate(AVAL = as.numeric(AVAL)) %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + RESULT = paste(getHazardRatio(AVAL, CNSR, TRT), + collapse = " ")) else .} %>% + {if (soc == TRUE) summarise(., + RESULT = paste(getHazardRatio(AVAL, CNSR, TRT), + collapse = " ")) else .} %>% + rowwise() %>% + mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), + TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% + select(-RESULT) %>% + mutate(LOGPTEST = -log(TESTP)) + } + + + + ### Rate Difference (Large Sample Approximation by CLT) ------------------------ + else if (test=="Rate Difference"){ + getRateDifference <- function(count1, count2, saval1, saval2) { + r <- ratedifference(a = count1, b = count2, PT1 = saval1, PT0 = saval2) + RD <- r$estimate + RDP <- r$p.value + + output <- c(RD, RDP) + return(output) + } + + result <- cbind(data.summary, data.extend.summary %>% select(SAVAL1, SAVAL2)) %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + RESULT = paste(getRateDifference(COUNT1, COUNT2, SAVAL1, SAVAL2), + collapse = " ")) else .} %>% + {if (soc == TRUE) summarise(., + RESULT = paste(getRateDifference(COUNT1, COUNT2, SAVAL1, SAVAL2), + collapse = " ")) else .} %>% + rowwise() %>% + mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), + TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% + select(-RESULT) %>% + mutate(LOGPTEST = -log(TESTP)) + } + + + + ### Rate Ratio (Large Sample Approximation by CLT) ----------------------------- + else if (test=="Rate Ratio"){ + getRateRatio <- function(count1, count2, saval1, saval2) { + r <- rateratio(a = count1, b = count2, PT1 = saval1, PT0 = saval2) + RR <- r$estimate + RRP <- r$p.value + + output <- c(RR, RRP) + return(output) + } + + result <- cbind(data.summary, data.extend.summary %>% select(SAVAL1, SAVAL2)) %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + RESULT = paste(getRateRatio(COUNT1, COUNT2, SAVAL1, SAVAL2), + collapse = " ")) else .} %>% + {if (soc == TRUE) summarise(., + RESULT = paste(getRateRatio(COUNT1, COUNT2, SAVAL1, SAVAL2), + collapse = " ")) else .} %>% + rowwise() %>% + mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), + TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% + select(-RESULT) %>% + mutate(LOGPTEST = -log(TESTP)) + } + + + ### Risk Difference (Large Sample Approximation by CLT) ------------------------ + else if (test=="Risk Difference"){ + getRiskDifference <- function(count1, count2) { + r <- riskdifference(a = count1, b = count2, N1 = N1.total, N0 = N2.total) + RD <- r$estimate + RDP <- r$p.value + + output <- c(RD, RDP) + return(output) + } + + result <- data.summary %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + RESULT = paste(getRiskDifference(COUNT1, COUNT2), + collapse = " ")) else .} %>% + {if (soc == TRUE) summarise(., + RESULT = paste(getRiskDifference(COUNT1, COUNT2), + collapse = " ")) else .} %>% + rowwise() %>% + mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), + TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% + select(-RESULT) %>% + mutate(LOGPTEST = -log(TESTP)) + } + + + + ### Risk Ratio (Large Sample Approximation by CLT) ----------------------------- + else if (test=="Risk Ratio"){ + # NEED N1 AND N2 + getRiskRatio <- function(count1, count2) { + r <- riskratio(X = count1, Y = count2, m1 = N1.total, m2 = N2.total) + RR <- r$estimate + RRP <- r$p.value + + output <- c(RR, RRP) + return(output) + } + + result <- data.summary %>% + {if (soc == FALSE) group_by(., AEDECOD) else .} %>% + {if (soc == TRUE) group_by(., AEBODSYS) else .} %>% + {if (soc == FALSE) summarise(., + AEBODSYS = first(AEBODSYS), + RESULT = paste(getRiskRatio(COUNT1, COUNT2), + collapse = " ")) else .} %>% + {if (soc == TRUE) summarise(., + RESULT = paste(getRiskRatio(COUNT1, COUNT2), + collapse = " ")) else .} %>% + rowwise() %>% + mutate(TEST = as.numeric(unlist(strsplit(RESULT, " "))[1]), + TESTP = as.numeric(unlist(strsplit(RESULT, " "))[2])) %>% + select(-RESULT) %>% + mutate(LOGPTEST = -log(TESTP)) + } + + + return(result) +} + diff --git a/README.md b/README.md index 823aca3..be7620c 100644 --- a/README.md +++ b/README.md @@ -1,7 +1,5 @@ # volcano-plot -Original Developers +![image](https://user-images.githubusercontent.com/62663896/90043322-efd45b00-dc99-11ea-834c-5633c91ea41d.png) -- Ke Xiao (Boehringer Ingelheim) -- Hong Wang (Boehringer Ingelheim) -- Dennis o'Brien (Boehringer Ingelheim) +Thanks to the team at Boehringer Ingelheim for developing and releasing the initial code for this tool. In particular, thanks to, Hong Wang, Ke Xiao and Dennis O'Brien. diff --git a/data/Get Test Data.Rmd b/data/Get Test Data.Rmd new file mode 100644 index 0000000..ace4f4e --- /dev/null +++ b/data/Get Test Data.Rmd @@ -0,0 +1,77 @@ + + +```{r} + +setwd("~/Desktop/volcano-plot") +library(scales); library(dplyr); library(tidyr); library(tibble); library(stringr); library(ggplot2); library(cowplot); library(ggpubr) +select <- dplyr::select; rename <- dplyr::rename; mutate <- dplyr::mutate; +summarize <- dplyr::summarize; arrange <- dplyr::arrange; slice <- dplyr::slice; filter <- dplyr::filter; recode<-dplyr::recode +style <- plotly::style +``` + + +Make test dataset +```{r} +# https://github.com/SafetyGraphics/volcano-plot/issues/7 +ae_vars = c("USUBJID", "AESEQ", "AESTDT", "AESTDY", "AEENDT", "AEENDY", "AETERM", "AEDECOD", "AEBODSYS", "AESER", "AEONGO", "AESEV", "AEREL", "AEOUT", "STUDYFL", "TRTEMFL") +dm_vars = c("SITE", "SITEID", "AGE", "SEX", "RACE", "ARM", "ARMCD", "SBJTSTAT", "RFSTDTC", "RFENDTC", "RFENDY", "SAFFL") +all_vars = c(ae_vars,dm_vars) + +# https://github.com/phuse-org/phuse-scripts/tree/master/data/sdtm/TDF_SDTM_v1.0 +library(haven) +library(readr) +adae <- haven::read_xpt("https://github.com/phuse-org/phuse-scripts/raw/master/data/adam/cdisc/adae.xpt") %>% select(USUBJID, TRTEMFL, SAFFL) +adsl <- haven::read_xpt("https://github.com/phuse-org/phuse-scripts/raw/master/data/adam/cdisc/adsl.xpt") +ae = read_xpt("data/ae.xpt") %>% select(-STUDYID, -DOMAIN ) +dm = read_xpt("data/dm.xpt")%>% select(-STUDYID, -DOMAIN ) +ds = read_xpt("data/ds.xpt")%>% select(-STUDYID, -DOMAIN ) %>% filter(EPOCH=="TREATMENT" & DSCAT=="DISPOSITION EVENT") %>% select(USUBJID,DSDECOD) + +test_data = ae %>% + inner_join(dm,by="USUBJID") %>% + inner_join(adae, by="USUBJID") %>% + left_join(ds, by="USUBJID") %>% + rename(AESTDT = AESTDTC, AEENDT = AEENDTC) %>% + mutate(AEONGO = ifelse(AEENDT=="","Y","N"), + STUDYFL = TRTEMFL, + SITE = SITEID, + RFENDTC = as.Date(RFENDTC), + AEENDT = as.Date(ifelse(AEENDT=="",NA,AEENDT)), + RFENDY = as.Date(RFENDTC) - AEENDT, + RFENDY = ifelse(AEENDT% select(match_vars) %>% group_by_all() %>% slice(1) %>% group_by() %>% as.data.frame() %>% + mutate(AESTDT = as.Date(AESTDT), AEENDT = as.Date(AEENDT), RFSTDTC = as.Date(RFSTDTC), RFENDTC = as.Date(RFENDTC)) +write_csv(test_data2, path="data/test_data.csv") + + +``` + + + +Load test data +```{r} + +setwd("~/Desktop/volcano-plot") +library(scales); library(dplyr); library(tidyr); library(tibble); library(stringr); library(ggplot2); library(cowplot); library(ggpubr) +select <- dplyr::select; rename <- dplyr::rename; mutate <- dplyr::mutate; +summarize <- dplyr::summarize; arrange <- dplyr::arrange; slice <- dplyr::slice; filter <- dplyr::filter; recode<-dplyr::recode +style <- plotly::style +``` + + +```{r} +library(data.table) + +test_data = fread("data/test_data.csv") %>% as.data.frame() %>% + mutate(AESTDT = as.Date(AESTDT), AEENDT = as.Date(AEENDT), RFSTDTC = as.Date(RFSTDTC), RFENDTC = as.Date(RFENDTC)) +``` \ No newline at end of file diff --git a/data/ae.xpt b/data/ae.xpt new file mode 100644 index 0000000..c60282e Binary files /dev/null and b/data/ae.xpt differ diff --git a/data/dm.xpt b/data/dm.xpt new file mode 100644 index 0000000..3602fbb Binary files /dev/null and b/data/dm.xpt differ diff --git a/data/ds.xpt b/data/ds.xpt new file mode 100644 index 0000000..cd0daaa Binary files /dev/null and b/data/ds.xpt differ diff --git a/data/test_data.csv b/data/test_data.csv new file mode 100644 index 0000000..620c0bc --- /dev/null +++ b/data/test_data.csv @@ -0,0 +1,1156 @@ +USUBJID,AESEQ,AESTDT,AESTDY,AEENDT,AEENDY,AETERM,AEDECOD,AEBODSYS,AESER,AEONGO,AESEV,AEREL,AEOUT,STUDYFL,TRTEMFL,SITE,SITEID,AGE,SEX,RACE,ARM,ARMCD,SBJTSTAT,RFSTDTC,RFENDTC,RFENDY,SAFFL +01-701-1015,1,2014-01-03,2,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT 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Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,55,Y +01-701-1211,3,2012-11-21,7,NA,NA,SHOULDER PAIN,SHOULDER PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,4,2012-11-22,8,NA,NA,INCONTINENCE,INCONTINENCE,RENAL AND URINARY DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,5,2012-11-29,15,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,6,2012-12-09,25,NA,NA,SKIN LACERATION,SKIN LACERATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,7,2013-01-11,58,NA,NA,CONFUSIONAL STATE,CONFUSIONAL STATE,PSYCHIATRIC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,8,2013-01-11,58,NA,NA,DYSPNOEA,DYSPNOEA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,NA,Y +01-701-1211,9,2013-01-14,61,2013-01-14,61,SUDDEN DEATH,SUDDEN DEATH,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,N,FATAL,Y,Y,701,701,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-15,2013-01-14,0,Y +01-701-1239,1,2014-01-12,2,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1239,2,2014-01-12,2,NA,NA,SKIN ODOUR ABNORMAL,SKIN ODOUR ABNORMAL,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1239,3,2014-01-13,3,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1239,5,2014-01-20,10,2014-02-08,29,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,154,Y +01-701-1239,6,2014-01-12,2,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1239,8,2014-02-20,41,2014-03-12,61,UPPER RESPIRATORY TRACT INFECTION,UPPER RESPIRATORY TRACT INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,122,Y +01-701-1239,9,NA,NA,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1239,10,NA,NA,NA,NA,HORDEOLUM,HORDEOLUM,INFECTIONS AND INFESTATIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-11,2014-07-11,NA,Y +01-701-1275,2,2014-02-23,17,2014-02-23,17,VOMITING,VOMITING,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,112,Y +01-701-1275,9,2014-03-12,34,2014-03-27,49,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,80,Y +01-701-1275,10,2014-03-12,34,2014-03-27,49,NASAL CONGESTION,NASAL CONGESTION,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,80,Y +01-701-1275,11,2014-02-13,7,2014-06-03,117,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,12,Y +01-701-1275,12,2014-02-24,18,2014-06-12,126,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,3,Y +01-701-1275,13,2014-02-24,18,2014-06-03,117,SALIVARY HYPERSECRETION,SALIVARY HYPERSECRETION,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,12,Y +01-701-1275,14,2014-02-24,18,2014-06-03,117,PAROSMIA,PAROSMIA,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,12,Y +01-701-1275,15,2014-02-24,18,2014-06-12,126,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,AMERICAN INDIAN OR ALASKA NATIVE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-07,2014-06-14,3,Y +01-701-1287,1,2014-01-26,2,NA,NA,SALIVARY HYPERSECRETION,SALIVARY HYPERSECRETION,GASTROINTESTINAL DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-25,2014-07-26,NA,Y +01-701-1287,2,2014-02-22,29,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-25,2014-07-26,NA,Y +01-701-1287,3,2014-03-09,44,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,56,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-25,2014-07-26,NA,Y +01-701-1287,5,2014-07-09,166,2014-07-12,169,RHINORRHOEA,RHINORRHOEA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,56,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-25,2014-07-26,15,Y +01-701-1294,1,2013-03-22,-2,2013-03-23,-1,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,N,RECOVERED/RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,84,Y +01-701-1294,1,2013-03-22,-2,2013-03-23,-1,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,84,Y +01-701-1294,2,2013-05-19,57,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,2,2013-05-19,57,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,3,2013-05-19,57,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,3,2013-05-19,57,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,4,2013-05-19,57,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,4,2013-05-19,57,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,5,2013-05-19,57,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,5,2013-05-19,57,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,6,2013-06-10,79,NA,NA,RASH ERYTHEMATOUS,RASH ERYTHEMATOUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1294,6,2013-06-10,79,NA,NA,RASH ERYTHEMATOUS,RASH ERYTHEMATOUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-06-14,NA,Y +01-701-1302,1,2013-08-30,2,NA,NA,APPLICATION SITE PERSPIRATION,APPLICATION SITE PERSPIRATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,2,2013-08-30,2,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,3,2013-08-30,2,NA,NA,STOMACH DISCOMFORT,STOMACH DISCOMFORT,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,4,2013-08-31,3,NA,NA,PAIN,PAIN,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,5,2013-09-01,4,NA,NA,NASAL CONGESTION,NASAL CONGESTION,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,6,2013-09-02,5,NA,NA,PHARYNGOLARYNGEAL PAIN,PHARYNGOLARYNGEAL PAIN,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,7,2013-09-02,5,NA,NA,PRODUCTIVE COUGH,PRODUCTIVE COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,8,2013-09-02,5,NA,NA,MALAISE,MALAISE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,9,2013-09-02,5,2013-09-03,6,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,64,Y +01-701-1302,10,2013-09-02,5,NA,NA,MYALGIA,MYALGIA,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,11,2013-09-04,7,NA,NA,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,13,2013-09-15,18,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,14,2013-09-30,33,NA,NA,EPISTAXIS,EPISTAXIS,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,15,2013-09-05,8,2013-10-08,41,CONTUSION,CONTUSION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,29,Y +01-701-1302,16,2013-10-15,48,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,17,2013-10-15,48,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,18,2013-09-02,5,NA,NA,MALAISE,MALAISE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,19,2013-10-23,56,NA,NA,RESPIRATORY TRACT CONGESTION,RESPIRATORY TRACT CONGESTION,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,20,2013-10-23,56,NA,NA,RHINITIS,RHINITIS,INFECTIONS AND INFESTATIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,21,2013-10-24,57,NA,NA,FEELING ABNORMAL,FEELING ABNORMAL,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,22,2013-10-24,57,NA,NA,LISTLESS,LISTLESS,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1302,23,2013-10-24,57,NA,NA,LIBIDO DECREASED,LIBIDO DECREASED,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,61,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-29,2013-11-05,NA,Y +01-701-1317,1,2014-05-13,-9,NA,NA,ONYCHOMYCOSIS,ONYCHOMYCOSIS,INFECTIONS AND INFESTATIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,1,2014-05-13,-9,NA,NA,ONYCHOMYCOSIS,ONYCHOMYCOSIS,INFECTIONS AND INFESTATIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,2,2014-05-13,-9,NA,NA,CYST,CYST,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,2,2014-05-13,-9,NA,NA,CYST,CYST,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,3,2014-06-23,33,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,3,2014-06-23,33,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,4,2014-06-23,33,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,4,2014-06-23,33,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,5,2014-06-23,33,NA,NA,APPLICATION SITE URTICARIA,APPLICATION SITE URTICARIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,5,2014-06-23,33,NA,NA,APPLICATION SITE URTICARIA,APPLICATION SITE URTICARIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,6,2014-07-04,44,NA,NA,DEPRESSED MOOD,DEPRESSED MOOD,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,6,2014-07-04,44,NA,NA,DEPRESSED MOOD,DEPRESSED MOOD,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,7,2014-07-04,44,NA,NA,DEPRESSED MOOD,DEPRESSED MOOD,PSYCHIATRIC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,7,2014-07-04,44,NA,NA,DEPRESSED MOOD,DEPRESSED MOOD,PSYCHIATRIC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,8,2014-09-12,114,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,8,2014-09-12,114,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,9,2014-11-03,166,NA,NA,DYSPHONIA,DYSPHONIA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1317,9,2014-11-03,166,NA,NA,DYSPHONIA,DYSPHONIA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-22,2014-11-20,NA,Y +01-701-1324,1,2012-10-22,21,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-02,2013-04-02,NA,Y +01-701-1324,2,2012-12-02,62,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-02,2013-04-02,NA,Y +01-701-1324,4,2012-12-25,85,2013-01-16,107,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-02,2013-04-02,77,Y +01-701-1341,1,2013-01-19,15,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,51,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-05,2013-02-07,NA,Y +01-701-1341,2,2013-01-19,15,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,51,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-05,2013-02-07,NA,Y +01-701-1341,3,2013-01-26,22,2013-01-30,26,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,701,701,51,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-05,2013-02-07,9,Y +01-701-1341,4,2013-01-26,22,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,51,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-05,2013-02-07,NA,Y +01-701-1341,5,2013-01-26,22,2013-01-30,26,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,701,701,51,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-05,2013-02-07,9,Y +01-701-1360,1,2013-08-02,3,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-07-31,2013-08-14,NA,Y +01-701-1360,2,2013-08-02,3,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-07-31,2013-08-14,NA,Y +01-701-1360,3,2013-08-05,6,NA,NA,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,67,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-07-31,2013-08-14,NA,Y +01-701-1363,1,2013-06-14,16,2013-06-15,17,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,701,701,81,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-05-30,2013-11-27,166,Y +01-701-1363,1,2013-06-14,16,2013-06-15,17,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,81,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-05-30,2013-11-27,166,Y +01-701-1363,2,NA,NA,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,701,701,81,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-05-30,2013-11-27,NA,Y +01-701-1363,2,NA,NA,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,81,F,BLACK OR AFRICAN 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+01-701-1363,6,2013-10-13,137,2013-10-15,139,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,701,701,81,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-05-30,2013-11-27,44,Y +01-701-1363,6,2013-10-13,137,2013-10-15,139,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,81,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-05-30,2013-11-27,44,Y +01-701-1383,1,2013-02-07,4,2013-02-07,4,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-04,2013-08-06,181,Y +01-701-1383,2,2013-02-07,4,2013-02-07,4,APPLICATION SITE PAIN,APPLICATION SITE PAIN,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-04,2013-08-06,181,Y +01-701-1383,3,2013-03-23,48,2013-03-26,51,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,701,701,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-04,2013-08-06,134,Y +01-701-1383,4,2013-03-23,48,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-04,2013-08-06,NA,Y +01-701-1383,5,2013-04-12,68,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-04,2013-08-06,NA,Y +01-701-1383,6,2013-04-12,68,NA,NA,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT 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Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,3,2013-01-19,15,NA,NA,SALIVARY HYPERSECRETION,SALIVARY HYPERSECRETION,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,4,2013-01-19,15,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,5,2013-01-19,15,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,6,2013-02-04,31,NA,NA,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,7,2013-02-04,31,NA,NA,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,NA,Y +01-701-1444,8,2013-02-08,35,2013-02-08,35,PARAESTHESIA,PARAESTHESIA,NERVOUS SYSTEM DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,701,701,63,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-02-13,6,Y +01-702-1082,4,2013-07-07,-19,2013-07-24,-2,URINE ANALYSIS ABNORMAL,URINE ANALYSIS ABNORMAL,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,117,Y +01-702-1082,4,2013-07-07,-19,2013-07-24,-2,URINE ANALYSIS ABNORMAL,URINE ANALYSIS ABNORMAL,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,117,Y +01-702-1082,5,2013-07-07,-19,2013-07-26,1,WHITE BLOOD CELL COUNT INCREASED,WHITE BLOOD CELL COUNT INCREASED,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,115,Y +01-702-1082,5,2013-07-07,-19,2013-07-26,1,WHITE BLOOD CELL COUNT INCREASED,WHITE BLOOD CELL COUNT INCREASED,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,115,Y +01-702-1082,6,2013-07-07,-19,2013-07-26,1,NEUTROPHIL COUNT INCREASED,NEUTROPHIL COUNT INCREASED,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,115,Y +01-702-1082,6,2013-07-07,-19,2013-07-26,1,NEUTROPHIL COUNT INCREASED,NEUTROPHIL COUNT INCREASED,INVESTIGATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,115,Y +01-702-1082,8,2013-09-02,39,2013-09-06,43,RECTAL HAEMORRHAGE,RECTAL HAEMORRHAGE,GASTROINTESTINAL DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,73,Y +01-702-1082,8,2013-09-02,39,2013-09-06,43,RECTAL HAEMORRHAGE,RECTAL HAEMORRHAGE,GASTROINTESTINAL DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,73,Y +01-702-1082,9,2013-09-09,46,2013-09-24,61,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,55,Y +01-702-1082,9,2013-09-09,46,2013-09-24,61,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,55,Y +01-702-1082,10,2013-10-12,79,2013-10-31,98,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,18,Y +01-702-1082,10,2013-10-12,79,2013-10-31,98,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,702,702,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-26,2013-11-17,18,Y +01-703-1042,1,2013-03-04,3,2013-03-05,4,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,703,703,64,M,WHITE,Placebo,Pbo,ONGOING,2013-03-02,2013-08-31,180,Y +01-703-1042,2,2013-03-05,4,2013-03-06,5,INSOMNIA,INSOMNIA,PSYCHIATRIC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,703,703,64,M,WHITE,Placebo,Pbo,ONGOING,2013-03-02,2013-08-31,179,Y +01-703-1076,1,2013-11-16,23,2013-11-16,23,BIOPSY PROSTATE,BIOPSY PROSTATE,INVESTIGATIONS,N,N,MODERATE,N,RECOVERED/RESOLVED,N,N,703,703,69,M,WHITE,Xanomeline 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Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,3,NA,NA,NA,NA,HYPERCHOLESTEROLAEMIA,HYPERCHOLESTEROLAEMIA,METABOLISM AND NUTRITION DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,4,2013-11-23,30,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,4,2013-11-23,30,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,5,2013-11-23,30,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,5,2013-11-23,30,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,6,2013-11-25,32,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,6,2013-11-25,32,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,7,2013-11-23,30,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1076,7,2013-11-23,30,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,69,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2013-12-24,NA,Y +01-703-1086,2,2012-09-13,12,2013-01-02,123,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,71,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-02,2012-12-24,-9,Y +01-703-1086,3,2012-09-13,12,2013-01-02,123,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,703,703,71,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-02,2012-12-24,-9,Y +01-703-1086,5,2012-10-09,38,2012-10-15,44,CHILLS,CHILLS,GENERAL DISORDERS AND 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Dose,Xan_Lo,ONGOING,2013-01-23,2013-07-08,NA,Y +01-704-1114,3,2013-03-23,60,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-23,2013-07-08,NA,Y +01-704-1114,4,2013-03-23,60,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-23,2013-07-08,NA,Y +01-704-1114,5,2013-06-07,136,2013-06-13,142,INFLUENZA,INFLUENZA,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,704,704,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-23,2013-07-08,26,Y +01-704-1120,1,2013-12-23,22,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,71,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-02,2014-02-03,NA,Y +01-704-1120,3,2013-12-23,22,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT 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Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-17,Y +01-704-1266,13,2013-11-08,27,2013-12-06,55,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,0,Y +01-704-1266,13,2013-11-08,27,2013-12-06,55,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,0,Y +01-704-1266,14,2013-11-15,34,2013-12-14,63,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-8,Y +01-704-1266,14,2013-11-15,34,2013-12-14,63,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-8,Y +01-704-1266,15,2013-11-15,34,2013-12-23,72,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-17,Y +01-704-1266,15,2013-11-15,34,2013-12-23,72,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-17,Y +01-704-1266,16,2013-12-06,55,2013-12-23,72,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-17,Y +01-704-1266,16,2013-12-06,55,2013-12-23,72,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,704,704,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-13,2013-12-06,-17,Y +01-704-1323,1,2013-07-30,23,2013-08-03,27,VIRAL INFECTION,VIRAL INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,704,704,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-08,2013-08-08,6,Y +01-704-1323,2,2013-08-04,28,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-08,2013-08-08,NA,Y +01-704-1323,3,2013-08-04,28,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-08,2013-08-08,NA,Y +01-704-1323,4,2013-08-04,28,NA,NA,OEDEMA,OEDEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-08,2013-08-08,NA,Y +01-704-1325,1,2014-05-23,31,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,81,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-04-23,2014-08-06,NA,Y +01-704-1325,2,2014-07-04,73,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,81,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-04-23,2014-08-06,NA,Y +01-704-1332,1,2013-12-10,2,2014-02-24,78,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-09,2014-02-16,-8,Y +01-704-1332,4,2014-02-03,57,NA,NA,BURNING SENSATION,BURNING SENSATION,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-09,2014-02-16,NA,Y +01-704-1332,5,2013-12-10,2,2014-02-24,78,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,704,704,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-09,2014-02-16,-8,Y +01-704-1332,6,2014-01-18,41,2014-02-24,78,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,704,704,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-09,2014-02-16,-8,Y +01-704-1351,3,2013-10-27,16,2014-04-04,175,POLLAKIURIA,POLLAKIURIA,RENAL AND URINARY DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,704,704,70,M,WHITE,Placebo,Pbo,ONGOING,2013-10-12,2014-04-18,15,Y +01-704-1351,4,2013-10-27,16,2014-04-04,175,FLATULENCE,FLATULENCE,GASTROINTESTINAL DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,704,704,70,M,WHITE,Placebo,Pbo,ONGOING,2013-10-12,2014-04-18,15,Y +01-704-1388,1,2012-08-23,-106,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,704,704,81,M,WHITE,Placebo,Pbo,ONGOING,2012-12-07,2013-06-19,NA,Y +01-704-1435,1,2013-01-06,51,NA,NA,PARKINSON'S DISEASE,PARKINSON'S DISEASE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,704,704,74,M,WHITE,Placebo,Pbo,ONGOING,2012-11-17,2013-01-12,NA,Y +01-704-1445,1,2014-10-31,174,2014-10-31,174,COMPLETED SUICIDE,COMPLETED SUICIDE,PSYCHIATRIC DISORDERS,N,N,SEVERE,N,FATAL,Y,Y,704,704,75,M,WHITE,Placebo,Pbo,ONGOING,2014-05-11,2014-11-01,2,Y +01-705-1031,1,2013-12-25,29,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,56,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-27,2014-05-11,NA,Y +01-705-1059,1,2013-11-02,90,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,66,F,WHITE,Placebo,Pbo,ONGOING,2013-08-05,2013-12-05,NA,Y +01-705-1186,1,2014-01-26,19,NA,NA,HYPERBILIRUBINAEMIA,HYPERBILIRUBINAEMIA,HEPATOBILIARY DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,84,F,WHITE,Placebo,Pbo,ONGOING,2014-01-08,2014-02-07,NA,Y +01-705-1199,2,2013-09-17,2,2013-09-29,14,DYSPEPSIA,DYSPEPSIA,GASTROINTESTINAL DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,705,705,87,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-16,2013-09-29,0,Y +01-705-1280,1,2014-04-20,94,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,56,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-17,2014-07-25,NA,Y +01-705-1281,1,2014-01-30,64,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,73,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-11-28,2014-03-17,NA,Y +01-705-1281,2,2014-01-30,64,NA,NA,EXCORIATION,EXCORIATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,73,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-11-28,2014-03-17,NA,Y +01-705-1281,3,2014-01-30,64,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,73,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-11-28,2014-03-17,NA,Y +01-705-1292,1,2013-10-28,15,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,60,F,BLACK OR AFRICAN AMERICAN,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-10-14,2014-05-14,NA,Y +01-705-1292,2,2014-02-13,123,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,60,F,BLACK OR AFRICAN AMERICAN,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-10-14,2014-05-14,NA,Y +01-705-1303,2,2014-02-05,52,2014-03-03,78,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,72,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-02,92,Y +01-705-1303,3,2014-02-05,52,2014-03-03,78,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,72,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-02,92,Y +01-705-1303,4,2014-02-05,52,2014-03-03,78,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,705,705,72,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-02,92,Y +01-705-1310,1,2013-11-14,13,NA,NA,RASH PRURITIC,RASH PRURITIC,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,74,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-11-02,2014-01-23,NA,Y +01-705-1310,2,2014-01-09,69,NA,NA,WOUND HAEMORRHAGE,WOUND HAEMORRHAGE,VASCULAR DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,74,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-11-02,2014-01-23,NA,Y +01-705-1349,1,2013-04-08,30,2013-04-08,30,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,86,F,WHITE,Placebo,Pbo,ONGOING,2013-03-10,2013-09-08,154,Y +01-705-1349,2,2013-04-11,33,2013-04-11,33,VOMITING,VOMITING,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,86,F,WHITE,Placebo,Pbo,ONGOING,2013-03-10,2013-09-08,151,Y +01-705-1349,3,2013-08-25,169,NA,NA,VENTRICULAR HYPERTROPHY,VENTRICULAR HYPERTROPHY,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,86,F,WHITE,Placebo,Pbo,ONGOING,2013-03-10,2013-09-08,NA,Y +01-705-1349,4,2013-08-25,169,NA,NA,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,86,F,WHITE,Placebo,Pbo,ONGOING,2013-03-10,2013-09-08,NA,Y +01-705-1393,1,2012-09-19,13,2012-09-24,18,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,150,Y +01-705-1393,1,2012-09-19,13,2012-09-24,18,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,150,Y +01-705-1393,3,2013-01-21,137,2013-01-24,140,COLON CANCER,COLON CANCER,"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)",N,N,SEVERE,N,RECOVERED/RESOLVED,N,N,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,28,Y +01-705-1393,3,2013-01-21,137,2013-01-24,140,COLON CANCER,COLON CANCER,"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)",N,N,SEVERE,N,RECOVERED/RESOLVED,Y,Y,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,28,Y +01-705-1393,4,2011-12-05,-277,2013-02-20,167,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,0,Y +01-705-1393,4,2011-12-05,-277,2013-02-20,167,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-07,2013-02-20,0,Y +01-705-1431,1,2013-06-22,-1,NA,NA,RASH ERYTHEMATOUS,RASH ERYTHEMATOUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,705,705,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-23,2013-12-19,NA,Y +01-705-1431,1,2013-06-22,-1,NA,NA,RASH ERYTHEMATOUS,RASH ERYTHEMATOUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,705,705,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-23,2013-12-19,NA,Y +01-705-1431,2,2013-07-04,12,2013-07-06,14,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,705,705,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-23,2013-12-19,167,Y +01-705-1431,2,2013-07-04,12,2013-07-06,14,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,705,705,68,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-23,2013-12-19,167,Y +01-706-1041,1,NA,NA,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,NA,Y +01-706-1041,1,NA,NA,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,NA,Y +01-706-1041,2,2014-01-07,8,2014-01-08,9,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,203,Y +01-706-1041,2,2014-01-07,8,2014-01-08,9,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,203,Y +01-706-1041,5,2014-01-14,15,2014-01-28,29,EXCORIATION,EXCORIATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,N,RECOVERED/RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,183,Y +01-706-1041,5,2014-01-14,15,2014-01-28,29,EXCORIATION,EXCORIATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,183,Y +01-706-1041,7,NA,NA,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,NA,Y +01-706-1041,7,NA,NA,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,NA,Y +01-706-1041,8,2014-01-15,16,2014-07-29,211,IRRITABILITY,IRRITABILITY,PSYCHIATRIC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,0,Y +01-706-1041,8,2014-01-15,16,2014-07-29,211,IRRITABILITY,IRRITABILITY,PSYCHIATRIC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,0,Y +01-706-1041,9,2014-03-04,64,2014-07-29,211,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,0,Y +01-706-1041,9,2014-03-04,64,2014-07-29,211,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,706,706,64,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-12-31,2014-07-29,0,Y +01-706-1049,1,2013-06-03,21,2013-06-03,21,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,706,706,60,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-14,2013-06-25,23,Y +01-706-1049,2,2013-06-18,36,2013-06-18,36,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,706,706,60,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-14,2013-06-25,8,Y +01-706-1384,6,2012-09-15,1,2012-09-29,15,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,706,706,74,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-15,2012-09-29,0,Y +01-706-1384,7,2012-09-15,1,2012-09-29,15,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,706,706,74,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-15,2012-09-29,0,Y +01-706-1384,8,2012-09-15,1,2012-09-29,15,EXCORIATION,EXCORIATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,706,706,74,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-15,2012-09-29,0,Y +01-706-1384,9,2012-09-23,9,2012-09-29,15,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,706,706,74,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-15,2012-09-29,0,Y +01-706-1384,10,2012-09-23,9,2012-09-29,15,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,706,706,74,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-15,2012-09-29,0,Y +01-707-1206,4,2013-11-26,30,2013-12-09,43,BLOOD CREATINE PHOSPHOKINASE INCREASED,BLOOD CREATINE PHOSPHOKINASE INCREASED,INVESTIGATIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,707,707,65,M,WHITE,Placebo,Pbo,ONGOING,2013-10-28,2014-04-27,140,Y +01-707-1206,5,2013-12-03,37,2013-12-10,44,POSTNASAL DRIP,POSTNASAL DRIP,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,707,707,65,M,WHITE,Placebo,Pbo,ONGOING,2013-10-28,2014-04-27,139,Y +01-707-1206,6,2013-11-25,29,2013-12-23,57,SINUS ARRHYTHMIA,SINUS ARRHYTHMIA,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,707,707,65,M,WHITE,Placebo,Pbo,ONGOING,2013-10-28,2014-04-27,126,Y +01-707-1206,8,2014-02-08,104,2014-02-22,118,CONJUNCTIVITIS,CONJUNCTIVITIS,EYE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,707,707,65,M,WHITE,Placebo,Pbo,ONGOING,2013-10-28,2014-04-27,65,Y +01-708-1019,1,2013-12-31,12,2013-12-31,12,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-20,2014-01-23,24,Y +01-708-1019,2,2014-01-01,13,2014-01-01,13,STUPOR,STUPOR,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-20,2014-01-23,23,Y +01-708-1019,3,2014-01-01,13,2014-01-01,13,TRANSIENT ISCHAEMIC ATTACK,TRANSIENT ISCHAEMIC ATTACK,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-20,2014-01-23,23,Y +01-708-1019,4,2014-01-01,13,2014-01-01,13,VISION BLURRED,VISION BLURRED,EYE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-20,2014-01-23,23,Y +01-708-1019,5,2014-01-01,13,2014-01-01,13,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-12-20,2014-01-23,23,Y +01-708-1032,1,2013-02-26,18,2013-03-09,29,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,708,708,62,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-09,2013-03-09,0,Y +01-708-1084,2,2013-05-23,15,2013-05-23,15,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-11-11,173,Y +01-708-1084,4,2013-06-09,32,2013-06-09,32,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-11-11,156,Y +01-708-1084,6,2013-06-23,46,2013-06-23,46,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-11-11,142,Y +01-708-1087,2,2013-01-19,90,2013-01-19,90,HEART RATE IRREGULAR,HEART RATE IRREGULAR,INVESTIGATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2012-10-22,2013-04-28,100,Y +01-708-1087,3,2013-02-04,106,2013-02-08,110,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2012-10-22,2013-04-28,80,Y +01-708-1087,4,2013-02-16,118,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2012-10-22,2013-04-28,NA,Y +01-708-1087,6,2013-03-16,146,2013-03-16,146,HEART RATE IRREGULAR,HEART RATE IRREGULAR,INVESTIGATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2012-10-22,2013-04-28,44,Y +01-708-1158,1,2014-02-25,18,NA,NA,AGITATION,AGITATION,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,81,F,WHITE,Placebo,Pbo,ONGOING,2014-02-08,2014-03-22,NA,Y +01-708-1158,2,2014-03-22,43,2014-03-22,43,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,81,F,WHITE,Placebo,Pbo,ONGOING,2014-02-08,2014-03-22,0,Y +01-708-1178,1,2013-12-19,-10,NA,NA,FLANK PAIN,FLANK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,NA,Y +01-708-1178,1,2013-12-19,-10,NA,NA,FLANK PAIN,FLANK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,NA,Y +01-708-1178,2,2014-03-01,63,2014-03-08,70,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,30,Y +01-708-1178,2,2014-03-01,63,2014-03-08,70,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,30,Y +01-708-1178,4,2014-03-09,71,NA,NA,VENTRICULAR SEPTAL DEFECT,VENTRICULAR SEPTAL DEFECT,"CONGENITAL, FAMILIAL AND GENETIC DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,NA,Y +01-708-1178,4,2014-03-09,71,NA,NA,VENTRICULAR SEPTAL DEFECT,VENTRICULAR SEPTAL DEFECT,"CONGENITAL, FAMILIAL AND GENETIC DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,NA,Y +01-708-1178,5,2014-03-09,71,2014-04-06,99,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,0,Y +01-708-1178,5,2014-03-09,71,2014-04-06,99,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,0,Y +01-708-1178,6,2014-03-24,86,2014-03-26,88,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,12,Y +01-708-1178,6,2014-03-24,86,2014-03-26,88,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,12,Y +01-708-1178,7,2014-03-24,86,2014-03-26,88,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,12,Y +01-708-1178,7,2014-03-24,86,2014-03-26,88,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,12,Y +01-708-1178,8,2014-03-24,86,2014-03-28,90,CYSTITIS,CYSTITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,10,Y +01-708-1178,8,2014-03-24,86,2014-03-28,90,CYSTITIS,CYSTITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,10,Y +01-708-1178,9,2014-03-24,86,2014-03-24,86,ALCOHOL USE,ALCOHOL USE,SOCIAL CIRCUMSTANCES,N,N,MILD,N,RECOVERED/RESOLVED,N,N,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,14,Y +01-708-1178,9,2014-03-24,86,2014-03-24,86,ALCOHOL USE,ALCOHOL USE,SOCIAL CIRCUMSTANCES,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,77,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-29,2014-04-06,14,Y +01-708-1213,2,2013-02-22,14,2013-02-22,14,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-09,2013-02-26,5,Y +01-708-1216,1,2012-11-06,14,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,78,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-24,2012-12-06,NA,Y +01-708-1216,3,2012-11-22,30,NA,NA,APPLICATION SITE SWELLING,APPLICATION SITE SWELLING,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,78,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-24,2012-12-06,NA,Y +01-708-1216,4,2012-11-06,14,2012-12-13,51,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,78,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-24,2012-12-06,-7,Y +01-708-1253,4,2013-05-06,-1,2013-05-16,10,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,N,N,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,174,Y +01-708-1253,4,2013-05-06,-1,2013-05-16,10,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,174,Y +01-708-1253,5,2013-05-06,-1,2013-05-16,10,CONJUNCTIVITIS,CONJUNCTIVITIS,EYE DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,174,Y +01-708-1253,5,2013-05-06,-1,2013-05-16,10,CONJUNCTIVITIS,CONJUNCTIVITIS,EYE DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,174,Y +01-708-1253,6,2013-05-07,1,2013-05-10,4,HEART RATE INCREASED,HEART RATE INCREASED,INVESTIGATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,180,Y +01-708-1253,6,2013-05-07,1,2013-05-10,4,HEART RATE INCREASED,HEART RATE INCREASED,INVESTIGATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,180,Y +01-708-1253,8,2013-06-07,32,2013-06-07,32,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,152,Y +01-708-1253,8,2013-06-07,32,2013-06-07,32,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,M,WHITE,Placebo,Pbo,ONGOING,2013-05-07,2013-11-05,152,Y +01-708-1272,1,2013-02-11,6,2013-02-11,6,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,53,Y +01-708-1272,2,2013-02-18,13,2013-02-18,13,MUSCLE SPASMS,MUSCLE SPASMS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,SEVERE,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,46,Y +01-708-1272,4,2013-02-27,22,2013-02-27,22,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,37,Y +01-708-1272,8,2013-03-01,24,2013-03-07,30,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,29,Y +01-708-1272,9,2013-03-01,24,2013-03-07,30,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,29,Y +01-708-1272,10,2013-03-07,30,2013-03-07,30,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,29,Y +01-708-1272,11,2013-03-19,42,2013-03-19,42,HOT FLUSH,HOT FLUSH,VASCULAR DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,17,Y +01-708-1272,12,2013-02-21,16,2013-03-20,43,VENTRICULAR EXTRASYSTOLES,VENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-06,2013-04-04,16,Y +01-708-1286,1,2013-09-12,3,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,80,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-09-10,2014-03-08,NA,Y +01-708-1286,2,2013-09-23,14,NA,NA,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,80,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-09-10,2014-03-08,NA,Y +01-708-1286,3,2014-02-18,162,2014-02-18,162,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,80,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-09-10,2014-03-08,19,Y +01-708-1286,4,2014-02-18,162,2014-02-18,162,CONSTIPATION,CONSTIPATION,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,80,F,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-09-10,2014-03-08,19,Y +01-708-1296,2,2013-06-27,14,2013-06-27,14,ATRIAL HYPERTROPHY,ATRIAL HYPERTROPHY,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,57,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-06-14,2013-12-12,169,Y +01-708-1296,4,2013-09-04,83,2013-09-18,97,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,57,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-06-14,2013-12-12,86,Y +01-708-1296,6,2013-10-04,113,2013-10-30,139,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,57,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-06-14,2013-12-12,44,Y +01-708-1296,7,2013-12-07,177,2013-12-07,177,PAIN IN EXTREMITY,PAIN IN EXTREMITY,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,57,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2013-06-14,2013-12-12,6,Y +01-708-1297,1,2013-04-02,68,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,61,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-25,2013-05-08,NA,Y +01-708-1297,2,2013-04-02,68,NA,NA,APPLICATION SITE SWELLING,APPLICATION SITE SWELLING,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,61,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-25,2013-05-08,NA,Y +01-708-1297,3,2013-05-08,104,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,61,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-01-25,2013-05-08,NA,Y +01-708-1316,1,2014-01-29,160,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2013-08-23,2014-03-01,NA,Y +01-708-1316,2,2014-02-15,177,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,74,F,WHITE,Placebo,Pbo,ONGOING,2013-08-23,2014-03-01,NA,Y +01-708-1336,1,2012-12-18,12,2012-12-18,12,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-07,2013-06-05,170,Y +01-708-1336,2,2013-01-12,37,2013-01-12,37,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-07,2013-06-05,145,Y +01-708-1336,3,2013-02-02,58,2013-02-02,58,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-07,2013-06-05,124,Y +01-708-1336,6,2013-04-10,125,2013-06-05,181,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-07,2013-06-05,0,Y +01-708-1336,7,2013-04-10,125,2013-06-05,181,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-07,2013-06-05,0,Y +01-708-1347,5,2013-06-13,55,2013-06-25,67,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-20,2013-06-18,-7,Y +01-708-1347,6,2013-06-13,55,2013-06-25,67,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-20,2013-06-18,-7,Y +01-708-1347,7,2013-06-13,55,2013-06-25,67,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-20,2013-06-18,-7,Y +01-708-1347,8,2013-06-13,55,2013-06-25,67,APPLICATION SITE SWELLING,APPLICATION SITE SWELLING,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,708,708,61,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-20,2013-06-18,-7,Y +01-708-1348,2,2013-08-18,14,2013-08-31,27,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-05,2014-02-13,167,Y +01-708-1348,3,2013-12-01,119,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-05,2014-02-13,NA,Y +01-708-1353,2,2013-08-18,46,2013-09-10,69,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,87,F,BLACK OR AFRICAN AMERICAN,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-04,2013-09-10,0,Y +01-708-1353,3,2013-08-28,56,2013-09-10,69,HYPOTENSION,HYPOTENSION,VASCULAR DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,87,F,BLACK OR AFRICAN AMERICAN,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-04,2013-09-10,0,Y +01-708-1372,1,2013-04-10,-2,NA,NA,ATRIOVENTRICULAR BLOCK SECOND DEGREE,ATRIOVENTRICULAR BLOCK SECOND DEGREE,CARDIAC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,708,708,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-12,2013-05-10,NA,Y +01-708-1406,2,2014-06-16,173,NA,NA,OEDEMA PERIPHERAL,OEDEMA PERIPHERAL,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,71,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-26,2014-07-02,NA,Y +01-708-1428,1,2013-11-22,14,2013-11-22,14,EPISTAXIS,EPISTAXIS,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,71,Y +01-708-1428,2,2013-12-10,32,2013-12-21,43,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-708-1428,3,2013-12-10,32,2013-12-21,43,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-708-1428,4,2013-12-10,32,2013-12-21,43,APPLICATION SITE WARMTH,APPLICATION SITE WARMTH,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-708-1428,5,2013-12-10,32,2013-12-21,43,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-708-1428,6,2013-12-10,32,2013-12-21,43,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-708-1428,7,2013-12-10,32,2013-12-21,43,APPLICATION SITE WARMTH,APPLICATION SITE WARMTH,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,708,708,84,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-11-09,2014-01-31,42,Y +01-709-1007,2,2012-08-16,17,2012-08-19,20,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,54,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-07-31,2012-09-01,14,Y +01-709-1007,3,2012-08-21,22,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,SEVERE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,54,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-07-31,2012-09-01,NA,Y +01-709-1007,4,2012-08-30,31,2012-08-30,31,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,54,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-07-31,2012-09-01,3,Y +01-709-1020,1,2012-12-27,27,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,72,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-01,2013-06-01,NA,Y +01-709-1020,2,2013-01-03,34,2013-01-11,42,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,72,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-01,2013-06-01,142,Y +01-709-1020,3,2013-01-03,34,2013-01-11,42,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,72,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-01,2013-06-01,142,Y +01-709-1020,4,2013-01-15,46,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,72,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-01,2013-06-01,NA,Y +01-709-1029,2,2013-01-17,24,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,NA,Y +01-709-1029,4,2013-01-09,16,2013-02-19,57,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,128,Y +01-709-1029,5,2013-01-24,31,2013-02-27,65,MUSCLE SPASMS,MUSCLE SPASMS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,120,Y +01-709-1029,8,2013-03-20,86,2013-04-16,113,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,72,Y +01-709-1029,9,2013-03-20,86,2013-04-16,113,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,72,Y +01-709-1029,12,2013-05-15,142,NA,NA,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,NA,Y +01-709-1029,13,2013-05-12,139,2013-05-19,146,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,39,Y +01-709-1029,14,2013-05-12,139,2013-05-19,146,PHARYNGEAL ERYTHEMA,PHARYNGEAL ERYTHEMA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,39,Y +01-709-1029,15,2013-06-12,170,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,NA,Y +01-709-1029,16,2013-06-19,177,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,82,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-25,2013-06-26,NA,Y +01-709-1081,1,2014-04-07,80,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,86,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-18,2014-05-10,NA,Y +01-709-1081,2,2014-05-01,104,NA,NA,OEDEMA PERIPHERAL,OEDEMA PERIPHERAL,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,86,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-18,2014-05-10,NA,Y +01-709-1088,1,2014-05-08,27,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,69,M,WHITE,Placebo,Pbo,ONGOING,2014-04-12,2014-10-09,NA,Y +01-709-1088,2,2014-08-02,113,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,69,M,WHITE,Placebo,Pbo,ONGOING,2014-04-12,2014-10-09,NA,Y +01-709-1099,2,2013-11-12,19,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,79,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2014-04-25,NA,Y +01-709-1099,3,2013-11-12,19,NA,NA,APPLICATION SITE VESICLES,APPLICATION SITE VESICLES,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,79,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2014-04-25,NA,Y +01-709-1099,4,2013-11-12,19,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,79,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2014-04-25,NA,Y +01-709-1099,5,2013-11-06,13,2013-11-17,24,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,79,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-25,2014-04-25,160,Y +01-709-1099,6,2013-11-12,19,NA,NA,APPLICATION SITE 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+01-709-1285,1,2013-04-14,22,NA,NA,HEMIANOPIA HOMONYMOUS,HEMIANOPIA HOMONYMOUS,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,87,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-05-31,NA,Y +01-709-1285,4,2013-05-19,57,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,87,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-05-31,NA,Y +01-709-1285,5,2013-04-19,27,2013-05-31,69,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,87,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-05-31,0,Y +01-709-1285,6,2013-04-19,27,2013-05-31,69,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,87,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-03-24,2013-05-31,0,Y 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+01-709-1309,12,2013-07-04,16,2013-07-04,16,ALLERGIC GRANULOMATOUS ANGIITIS,ALLERGIC GRANULOMATOUS ANGIITIS,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,709,709,65,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-19,2013-12-19,169,Y +01-709-1309,13,2013-06-18,-1,2013-07-16,28,RASH PAPULAR,RASH PAPULAR,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,709,709,65,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-19,2013-12-19,157,Y +01-709-1309,13,2013-06-18,-1,2013-07-16,28,RASH PAPULAR,RASH PAPULAR,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,65,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-19,2013-12-19,157,Y +01-709-1309,14,2013-07-28,40,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,709,709,65,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-19,2013-12-19,NA,Y 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+01-709-1312,2,2014-10-19,183,NA,NA,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,68,F,WHITE,Placebo,Pbo,ONGOING,2014-04-20,2014-10-19,NA,Y +01-709-1326,1,2013-05-01,27,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,NA,Y +01-709-1326,2,2013-05-01,27,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,NA,Y +01-709-1326,3,2013-05-21,47,2013-05-21,47,VOMITING,VOMITING,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,135,Y +01-709-1326,4,2013-05-21,47,2013-05-21,47,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,135,Y +01-709-1326,5,2013-06-07,64,2013-06-17,74,APPLICATION SITE BLEEDING,APPLICATION SITE BLEEDING,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,108,Y +01-709-1326,6,2013-07-12,99,NA,NA,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,709,709,75,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-05,2013-10-02,NA,Y +01-709-1329,1,2013-08-25,11,2013-08-25,11,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,709,709,70,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-15,2013-08-29,5,Y +01-709-1329,2,2013-08-25,11,2013-08-25,11,PYREXIA,PYREXIA,GENERAL DISORDERS AND ADMINISTRATION SITE 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+01-709-1424,1,2013-03-07,5,2013-03-07,5,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,Y,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,709,709,77,M,WHITE,Xanomeline High Dose,Xan_Hi,DISCONTINUED,2013-03-03,2013-03-08,2,Y +01-710-1002,2,2014-01-16,3,2014-01-20,7,TRANSIENT ISCHAEMIC ATTACK,TRANSIENT ISCHAEMIC ATTACK,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,88,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-01-18,-2,Y +01-710-1006,1,2013-02-18,9,2013-02-19,10,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,173,Y +01-710-1006,2,2013-03-01,20,NA,NA,SALIVARY HYPERSECRETION,SALIVARY HYPERSECRETION,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,NA,Y +01-710-1006,3,2013-03-01,20,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,NA,Y +01-710-1006,4,2013-04-16,66,2013-04-16,66,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,117,Y +01-710-1006,5,2013-04-17,67,2013-04-19,69,URINARY TRACT INFECTION,URINARY TRACT INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,114,Y +01-710-1006,6,2013-04-17,67,2013-04-17,67,NEPHROLITHIASIS,NEPHROLITHIASIS,RENAL AND URINARY DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,116,Y +01-710-1006,7,2013-05-18,98,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,NA,Y +01-710-1006,9,2013-06-29,140,2013-07-04,145,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,38,Y +01-710-1006,10,2013-08-08,180,2013-08-08,180,FALL,FALL,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,3,Y +01-710-1006,11,2013-08-08,180,NA,NA,FACIAL BONES FRACTURE,FACIAL BONES FRACTURE,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,NA,Y +01-710-1006,12,2013-08-08,180,NA,NA,CONTUSION,CONTUSION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-10,2013-08-10,NA,Y +01-710-1021,1,2013-10-10,14,2013-10-10,14,CHEST PAIN,CHEST PAIN,GENERAL 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Dose,Xan_Lo,ONGOING,2013-06-03,2013-08-17,57,Y +01-710-1045,5,2013-07-02,30,2013-07-09,37,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-03,2013-08-17,40,Y +01-710-1045,9,2013-07-02,30,2013-08-17,76,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-03,2013-08-17,0,Y +01-710-1045,10,2013-07-02,30,2013-08-17,76,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-03,2013-08-17,0,Y +01-710-1045,11,2013-07-22,50,2013-08-17,76,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-06-03,2013-08-17,0,Y +01-710-1045,12,2013-08-03,62,2013-08-17,76,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS 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DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,185,Y +01-710-1060,3,2013-01-04,4,2013-01-15,15,INSOMNIA,INSOMNIA,PSYCHIATRIC DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,172,Y +01-710-1060,4,2013-01-21,21,2013-01-21,21,APPLICATION SITE INDURATION,APPLICATION SITE INDURATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,166,Y +01-710-1060,5,2013-01-23,23,2013-01-23,23,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,164,Y +01-710-1060,6,2013-01-31,31,2013-01-31,31,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,156,Y +01-710-1060,7,2013-02-08,39,2013-02-08,39,FALL,FALL,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,148,Y +01-710-1060,8,2013-02-09,40,2013-02-09,40,FALL,FALL,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,82,M,WHITE,Placebo,Pbo,ONGOING,2013-01-01,2013-07-05,147,Y +01-710-1070,1,2012-10-06,29,NA,NA,SUPRAVENTRICULAR EXTRASYSTOLES,SUPRAVENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,NA,Y +01-710-1070,2,2012-12-12,96,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,NA,Y +01-710-1070,3,2012-12-12,96,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,NA,Y +01-710-1070,4,2012-12-12,96,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,NA,Y +01-710-1070,5,2013-01-22,137,2013-01-25,140,HIP FRACTURE,HIP FRACTURE,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,SEVERE,N,RECOVERED/RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,30,Y +01-710-1070,6,2013-02-05,151,2013-02-10,156,GASTROINTESTINAL HAEMORRHAGE,GASTROINTESTINAL HAEMORRHAGE,GASTROINTESTINAL DISORDERS,N,N,SEVERE,N,RECOVERED/RESOLVED,Y,Y,710,710,85,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-09-08,2013-02-23,14,Y +01-710-1077,1,2013-12-12,26,2013-12-12,26,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,158,Y +01-710-1077,1,2013-12-12,26,2013-12-12,26,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,158,Y +01-710-1077,2,2013-12-27,41,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,2,2013-12-27,41,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,3,2014-01-12,57,NA,NA,AGITATION,AGITATION,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,3,2014-01-12,57,NA,NA,AGITATION,AGITATION,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,4,NA,NA,NA,NA,ARTHRITIS,ARTHRITIS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,SEVERE,N,NOT RECOVERED/NOT RESOLVED,N,N,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,4,NA,NA,NA,NA,ARTHRITIS,ARTHRITIS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,SEVERE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,5,NA,NA,NA,NA,ARTHRITIS,ARTHRITIS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1077,5,NA,NA,NA,NA,ARTHRITIS,ARTHRITIS,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,76,F,WHITE,Placebo,Pbo,ONGOING,2013-11-17,2014-05-18,NA,Y +01-710-1083,1,2013-08-02,12,2013-08-02,12,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,SEVERE,Y,FATAL,Y,Y,710,710,89,F,WHITE,Placebo,Pbo,ONGOING,2013-07-22,2013-08-03,2,Y +01-710-1137,1,2013-10-13,3,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-11,2013-11-13,NA,Y +01-710-1137,2,2013-10-13,3,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-11,2013-11-13,NA,Y +01-710-1137,3,2013-11-04,25,NA,NA,VERTIGO,VERTIGO,EAR AND LABYRINTH DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-11,2013-11-13,NA,Y +01-710-1137,4,2013-11-13,34,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-10-11,2013-11-13,NA,Y +01-710-1142,1,2012-10-04,3,2012-10-06,5,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-02,2012-10-23,18,Y +01-710-1142,2,2012-10-04,3,2012-10-06,5,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-02,2012-10-23,18,Y +01-710-1142,3,2012-10-14,13,2012-10-14,13,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-02,2012-10-23,10,Y +01-710-1142,4,2012-10-19,18,2012-10-19,18,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-02,2012-10-23,5,Y +01-710-1142,5,2012-10-19,18,2012-10-19,18,SYNCOPE VASOVAGAL,SYNCOPE VASOVAGAL,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,76,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-02,2012-10-23,5,Y +01-710-1154,1,2014-04-18,21,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,84,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-29,2014-05-09,NA,Y +01-710-1154,2,2014-04-18,21,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,SEVERE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,84,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-29,2014-05-09,NA,Y +01-710-1166,1,2013-03-19,110,2013-03-19,110,FALL,FALL,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-30,2013-03-30,12,Y +01-710-1166,2,2013-03-19,110,2013-03-19,110,SKIN LACERATION,SKIN LACERATION,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-30,2013-03-30,12,Y +01-710-1166,3,2013-03-19,110,2013-03-19,110,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-30,2013-03-30,12,Y +01-710-1166,4,2013-03-19,110,2013-03-20,111,COMPLEX PARTIAL SEIZURES,COMPLEX PARTIAL SEIZURES,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-30,2013-03-30,11,Y +01-710-1166,5,2013-03-20,111,2013-03-20,111,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-11-30,2013-03-30,11,Y +01-710-1183,1,2014-03-10,115,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,80,F,WHITE,Placebo,Pbo,ONGOING,2013-11-16,2014-05-17,NA,Y +01-710-1183,2,2014-03-10,115,NA,NA,ATRIOVENTRICULAR BLOCK FIRST DEGREE,ATRIOVENTRICULAR BLOCK FIRST DEGREE,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,80,F,WHITE,Placebo,Pbo,ONGOING,2013-11-16,2014-05-17,NA,Y +01-710-1187,1,2012-12-23,44,NA,NA,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-11-10,2013-05-12,NA,Y +01-710-1235,1,2012-11-22,58,2012-12-14,80,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,710,710,56,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-26,2013-03-27,104,Y +01-710-1235,2,2013-01-13,110,NA,NA,SHOULDER PAIN,SHOULDER PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,56,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-26,2013-03-27,NA,Y +01-710-1235,3,2013-01-29,126,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,56,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-26,2013-03-27,NA,Y +01-710-1249,1,2014-02-11,46,2014-02-11,46,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-28,2014-06-28,138,Y +01-710-1249,2,2014-02-18,53,2014-02-18,53,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-28,2014-06-28,131,Y +01-710-1249,3,2014-02-23,58,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-28,2014-06-28,NA,Y +01-710-1249,4,2014-04-24,118,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-28,2014-06-28,NA,Y +01-710-1264,1,2013-07-03,21,2013-07-05,23,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,100,Y +01-710-1264,2,2013-08-21,70,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,NA,Y +01-710-1264,3,2013-08-21,70,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,NA,Y +01-710-1264,4,2013-09-29,109,2013-09-29,109,COLD SWEAT,COLD SWEAT,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,14,Y +01-710-1264,5,2013-09-29,109,2013-09-29,109,CHILLS,CHILLS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,14,Y +01-710-1264,6,2013-10-09,119,2013-10-09,119,COLD SWEAT,COLD SWEAT,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,4,Y +01-710-1264,7,2013-10-09,119,2013-10-09,119,CHILLS,CHILLS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,4,Y +01-710-1264,8,2013-10-11,121,2013-10-11,121,COLD SWEAT,COLD SWEAT,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,2,Y +01-710-1264,9,2013-10-11,121,2013-10-11,121,CHILLS,CHILLS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,78,M,WHITE,Placebo,Pbo,ONGOING,2013-06-13,2013-10-12,2,Y +01-710-1270,1,2014-02-23,12,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-02-12,2014-03-01,NA,Y +01-710-1270,2,2014-02-23,12,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-02-12,2014-03-01,NA,Y +01-710-1271,1,2012-11-21,56,2012-11-21,56,DYSPNOEA,DYSPNOEA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,86,F,WHITE,Placebo,Pbo,ONGOING,2012-09-27,2012-12-02,12,Y +01-710-1271,2,2012-11-21,56,2012-11-21,56,MYOCARDIAL INFARCTION,MYOCARDIAL INFARCTION,CARDIAC DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,710,710,86,F,WHITE,Placebo,Pbo,ONGOING,2012-09-27,2012-12-02,12,Y +01-710-1271,3,2012-11-21,56,2012-11-26,61,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,86,F,WHITE,Placebo,Pbo,ONGOING,2012-09-27,2012-12-02,7,Y +01-710-1271,4,2012-11-22,57,NA,NA,CARDIAC FAILURE CONGESTIVE,CARDIAC FAILURE CONGESTIVE,CARDIAC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,86,F,WHITE,Placebo,Pbo,ONGOING,2012-09-27,2012-12-02,NA,Y +01-710-1271,5,2012-11-22,57,2012-11-26,61,HYPONATRAEMIA,HYPONATRAEMIA,METABOLISM AND NUTRITION DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,86,F,WHITE,Placebo,Pbo,ONGOING,2012-09-27,2012-12-02,7,Y +01-710-1278,1,2013-01-13,21,2013-01-19,27,SOMNOLENCE,SOMNOLENCE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-24,2013-03-03,44,Y +01-710-1278,4,2013-02-24,63,2013-02-26,65,BURNING SENSATION,BURNING SENSATION,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-24,2013-03-03,6,Y +01-710-1278,5,2013-03-02,69,2013-03-02,69,VOMITING,VOMITING,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-24,2013-03-03,2,Y +01-710-1278,6,2013-02-07,46,2013-03-03,70,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-24,2013-03-03,0,Y +01-710-1278,7,2013-02-24,63,2013-03-03,70,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-24,2013-03-03,0,Y +01-710-1300,1,2013-01-31,48,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-15,2013-02-19,NA,Y +01-710-1300,2,2013-02-10,58,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-15,2013-02-19,NA,Y +01-710-1300,3,2013-02-10,58,NA,NA,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-15,2013-02-19,NA,Y +01-710-1300,4,2013-02-13,61,NA,NA,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-15,2013-02-19,NA,Y +01-710-1314,2,2013-05-20,27,2013-05-24,31,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,78,F,WHITE,Placebo,Pbo,ONGOING,2013-04-24,2013-05-25,2,Y +01-710-1315,1,2013-02-26,-1,2013-02-26,-1,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,141,Y +01-710-1315,1,2013-02-26,-1,2013-02-26,-1,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,141,Y +01-710-1315,5,2013-05-14,77,2013-07-07,131,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1315,5,2013-05-14,77,2013-07-07,131,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1315,6,2013-06-18,112,2013-07-07,131,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1315,6,2013-06-18,112,2013-07-07,131,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1315,7,2013-06-18,112,2013-07-07,131,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1315,7,2013-06-18,112,2013-07-07,131,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,710,710,83,F,WHITE,Placebo,Pbo,ONGOING,2013-02-27,2013-07-16,10,Y +01-710-1354,1,2012-12-30,50,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-11-11,2013-05-01,NA,Y +01-710-1354,2,2013-02-14,96,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,73,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-11-11,2013-05-01,NA,Y +01-710-1358,1,2012-12-22,97,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-17,2013-03-12,NA,Y +01-710-1358,2,2012-12-22,97,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-17,2013-03-12,NA,Y +01-710-1358,3,2013-01-24,130,NA,NA,APPLICATION SITE DESQUAMATION,APPLICATION SITE DESQUAMATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-09-17,2013-03-12,NA,Y +01-710-1368,2,2014-03-26,155,NA,NA,DELUSION,DELUSION,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,88,F,WHITE,Placebo,Pbo,ONGOING,2013-10-23,2014-04-24,NA,Y +01-710-1368,3,2014-03-26,155,NA,NA,PSYCHOMOTOR HYPERACTIVITY,PSYCHOMOTOR HYPERACTIVITY,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,88,F,WHITE,Placebo,Pbo,ONGOING,2013-10-23,2014-04-24,NA,Y +01-710-1368,4,2013-12-25,64,2014-04-24,184,HIP FRACTURE,HIP FRACTURE,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,SEVERE,N,RECOVERED/RESOLVED,Y,Y,710,710,88,F,WHITE,Placebo,Pbo,ONGOING,2013-10-23,2014-04-24,0,Y +01-710-1385,2,2012-11-12,15,2012-11-13,16,SUPRAVENTRICULAR TACHYCARDIA,SUPRAVENTRICULAR TACHYCARDIA,CARDIAC DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,98,Y +01-710-1385,3,2012-11-26,29,NA,NA,ATRIOVENTRICULAR BLOCK FIRST DEGREE,ATRIOVENTRICULAR BLOCK FIRST DEGREE,CARDIAC DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1385,4,2012-12-18,51,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1385,5,2012-12-27,60,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1385,6,2012-12-27,60,NA,NA,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1385,7,2013-02-18,113,NA,NA,ATRIAL FIBRILLATION,ATRIAL FIBRILLATION,CARDIAC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1385,8,2013-02-18,113,NA,NA,ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED,ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,710,710,77,M,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2012-10-29,2013-02-18,NA,Y +01-710-1408,2,2013-01-31,27,2013-02-09,36,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,710,710,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-07-12,154,Y +01-710-1408,4,2013-02-24,51,2013-05-31,147,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,710,710,80,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-05,2013-07-12,43,Y +01-711-1012,1,2013-04-16,14,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,NA,Y +01-711-1012,2,2013-04-16,14,2013-05-02,30,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,0,Y +01-711-1012,3,2013-04-16,14,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,NA,Y +01-711-1012,5,2013-04-27,25,NA,NA,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,NA,Y +01-711-1012,6,2013-04-29,27,2013-05-01,29,APPLICATION SITE URTICARIA,APPLICATION SITE URTICARIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,2,Y +01-711-1012,7,2013-04-16,14,2013-05-02,30,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,711,711,67,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-04-03,2013-05-02,0,Y +01-711-1036,1,2012-07-29,1,NA,NA,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,70,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2012-07-29,2013-02-10,NA,Y +01-711-1036,3,2012-08-12,15,NA,NA,GLOSSITIS,GLOSSITIS,GASTROINTESTINAL DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,70,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2012-07-29,2013-02-10,NA,Y +01-711-1036,4,2012-08-04,7,2012-08-12,15,EAR INFECTION,EAR INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,711,711,70,M,BLACK OR AFRICAN AMERICAN,Placebo,Pbo,ONGOING,2012-07-29,2013-02-10,183,Y +01-711-1143,1,NA,NA,NA,NA,TINNITUS,TINNITUS,EAR AND LABYRINTH DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,1,NA,NA,NA,NA,TINNITUS,TINNITUS,EAR AND LABYRINTH DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,2,2013-04-11,9,NA,NA,PARAESTHESIA ORAL,PARAESTHESIA ORAL,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,2,2013-04-11,9,NA,NA,PARAESTHESIA ORAL,PARAESTHESIA ORAL,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,3,2013-04-28,26,2013-05-11,39,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,SEVERE,N,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,22,Y +01-711-1143,3,2013-04-28,26,2013-05-11,39,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,SEVERE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,22,Y +01-711-1143,6,2013-04-28,26,2013-05-11,39,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,22,Y +01-711-1143,6,2013-04-28,26,2013-05-11,39,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,22,Y +01-711-1143,7,2013-04-29,27,2013-05-15,43,SUPRAVENTRICULAR EXTRASYSTOLES,SUPRAVENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,18,Y +01-711-1143,7,2013-04-29,27,2013-05-15,43,SUPRAVENTRICULAR EXTRASYSTOLES,SUPRAVENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,18,Y +01-711-1143,8,2013-05-18,46,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,8,2013-05-18,46,NA,NA,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,11,2013-05-27,55,2013-05-31,59,RASH PRURITIC,RASH PRURITIC,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,2,Y +01-711-1143,11,2013-05-27,55,2013-05-31,59,RASH PRURITIC,RASH PRURITIC,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,2,Y +01-711-1143,12,2013-05-30,58,NA,NA,CONJUNCTIVAL HAEMORRHAGE,CONJUNCTIVAL HAEMORRHAGE,EYE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,12,2013-05-30,58,NA,NA,CONJUNCTIVAL HAEMORRHAGE,CONJUNCTIVAL HAEMORRHAGE,EYE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,13,2013-06-01,60,NA,NA,CERUMEN IMPACTION,CERUMEN IMPACTION,EAR AND LABYRINTH DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,13,2013-06-01,60,NA,NA,CERUMEN IMPACTION,CERUMEN IMPACTION,EAR AND LABYRINTH DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,NA,Y +01-711-1143,14,2013-05-28,56,2013-06-01,60,VENTRICULAR EXTRASYSTOLES,VENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,0,Y +01-711-1143,14,2013-05-28,56,2013-06-01,60,VENTRICULAR EXTRASYSTOLES,VENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,711,711,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,DISCONTINUED,2013-04-03,2013-06-01,0,Y +01-711-1433,1,2012-07-23,-188,NA,NA,HYPERTENSION,HYPERTENSION,VASCULAR DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,N,N,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-711-1433,1,2012-07-23,-188,NA,NA,HYPERTENSION,HYPERTENSION,VASCULAR DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-711-1433,2,2012-07-23,-188,NA,NA,HYPERTENSION,HYPERTENSION,VASCULAR DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-711-1433,2,2012-07-23,-188,NA,NA,HYPERTENSION,HYPERTENSION,VASCULAR DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-711-1433,3,2013-02-05,10,NA,NA,ASTHENIA,ASTHENIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-711-1433,3,2013-02-05,10,NA,NA,ASTHENIA,ASTHENIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,711,711,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-01-27,2013-02-06,NA,Y +01-713-1043,1,2013-09-26,12,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-15,2014-03-24,NA,Y +01-713-1043,4,2013-09-26,12,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-15,2014-03-24,NA,Y +01-713-1043,5,2013-10-11,27,2013-10-11,27,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,713,713,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-15,2014-03-24,165,Y +01-713-1043,6,2013-10-11,27,2013-10-11,27,VOMITING,VOMITING,GASTROINTESTINAL DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,713,713,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-15,2014-03-24,165,Y +01-713-1043,7,2014-03-08,175,2014-03-08,175,CATARACT OPERATION,CATARACT OPERATION,SURGICAL AND MEDICAL PROCEDURES,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,713,713,78,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-09-15,2014-03-24,17,Y +01-713-1073,1,2014-07-14,107,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,74,F,BLACK OR AFRICAN AMERICAN,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-30,2014-10-05,NA,Y +01-713-1141,2,2013-06-21,22,2013-07-15,46,RASH PRURITIC,RASH PRURITIC,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-31,2013-08-06,23,Y +01-713-1141,3,2013-06-30,31,NA,NA,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-31,2013-08-06,NA,Y +01-713-1141,4,2013-07-01,32,2013-07-15,46,DELIRIUM,DELIRIUM,PSYCHIATRIC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,713,713,79,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-31,2013-08-06,23,Y +01-713-1179,1,2013-08-19,11,2013-08-23,15,DYSURIA,DYSURIA,RENAL AND URINARY DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,167,Y +01-713-1179,2,2013-08-22,14,2013-08-22,14,DYSPEPSIA,DYSPEPSIA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,168,Y +01-713-1179,4,2013-09-05,28,NA,NA,ASTHENIA,ASTHENIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,NA,Y +01-713-1179,5,2013-08-28,20,2013-09-08,31,URINARY TRACT INFECTION,URINARY TRACT INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,151,Y +01-713-1179,6,2013-09-05,28,NA,NA,ASTHENIA,ASTHENIA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,NA,Y +01-713-1179,7,2013-09-12,35,NA,NA,DYSPEPSIA,DYSPEPSIA,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,NA,Y +01-713-1179,9,2013-10-10,63,2013-10-13,66,GASTROENTERITIS VIRAL,GASTROENTERITIS VIRAL,INFECTIONS AND INFESTATIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,116,Y +01-713-1179,10,2013-10-10,63,NA,NA,GASTROOESOPHAGEAL REFLUX DISEASE,GASTROOESOPHAGEAL REFLUX DISEASE,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,NA,Y +01-713-1179,13,2013-11-23,107,2013-12-02,116,VAGINAL MYCOSIS,VAGINAL MYCOSIS,INFECTIONS AND INFESTATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,66,Y +01-713-1179,14,2013-11-23,107,2013-12-02,116,CERVICITIS,CERVICITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,66,Y +01-713-1179,15,2013-10-10,63,2014-01-18,163,PELVIC PAIN,PELVIC PAIN,REPRODUCTIVE SYSTEM AND BREAST DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,64,F,WHITE,Placebo,Pbo,ONGOING,2013-08-09,2014-02-05,19,Y +01-713-1209,1,2013-05-30,4,NA,NA,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,77,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-27,2013-11-22,NA,Y +01-713-1209,2,2013-06-02,7,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,77,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-27,2013-11-22,NA,Y +01-713-1209,3,2013-05-30,4,NA,NA,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,77,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-27,2013-11-22,NA,Y +01-713-1209,4,2013-10-31,158,NA,NA,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,77,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-27,2013-11-22,NA,Y +01-713-1256,2,2012-10-30,42,2012-10-31,43,APPLICATION SITE DERMATITIS,APPLICATION SITE DERMATITIS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,71,M,WHITE,Placebo,Pbo,ONGOING,2012-09-19,2013-03-25,146,Y +01-713-1269,1,2014-02-02,7,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1269,2,2014-04-18,82,NA,NA,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1269,3,2014-06-01,126,NA,NA,SHOULDER PAIN,SHOULDER PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1269,4,2014-07-10,165,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1269,5,2014-06-01,126,NA,NA,SHOULDER PAIN,SHOULDER PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1269,6,2014-07-10,165,NA,NA,RASH,RASH,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,713,713,73,M,WHITE,Placebo,Pbo,ONGOING,2014-01-27,2014-07-28,NA,Y +01-713-1448,3,2014-03-19,60,2014-05-23,125,APPLICATION SITE IRRITATION,APPLICATION SITE IRRITATION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,713,713,71,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-19,2014-05-17,-6,Y +01-713-1448,4,2014-03-27,68,2014-05-23,125,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,713,713,71,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-19,2014-05-17,-6,Y +01-714-1035,2,2014-05-26,40,NA,NA,ELECTROCARDIOGRAM T WAVE INVERSION,ELECTROCARDIOGRAM T WAVE INVERSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,88,F,WHITE,Placebo,Pbo,ONGOING,2014-04-17,2014-10-16,NA,Y +01-714-1035,4,2014-06-04,49,NA,NA,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,88,F,WHITE,Placebo,Pbo,ONGOING,2014-04-17,2014-10-16,NA,Y +01-714-1035,5,2014-05-26,40,2014-06-04,49,BUNDLE BRANCH BLOCK RIGHT,BUNDLE BRANCH BLOCK RIGHT,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,88,F,WHITE,Placebo,Pbo,ONGOING,2014-04-17,2014-10-16,135,Y +01-714-1035,6,2014-06-04,49,2014-06-17,62,SUPRAVENTRICULAR EXTRASYSTOLES,SUPRAVENTRICULAR EXTRASYSTOLES,CARDIAC DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,88,F,WHITE,Placebo,Pbo,ONGOING,2014-04-17,2014-10-16,122,Y +01-714-1035,7,2014-07-18,93,2014-07-24,99,BRONCHITIS,BRONCHITIS,INFECTIONS AND INFESTATIONS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,714,714,88,F,WHITE,Placebo,Pbo,ONGOING,2014-04-17,2014-10-16,85,Y +01-714-1068,2,2013-08-12,5,2013-08-22,15,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,714,714,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-08,2013-10-16,56,Y +01-714-1068,3,2013-09-20,44,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-08,2013-10-16,NA,Y +01-714-1068,4,2013-09-20,44,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-08,2013-10-16,NA,Y +01-714-1068,5,2013-09-20,44,NA,NA,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-08,2013-10-16,NA,Y +01-714-1068,6,2013-09-20,44,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,79,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-08-08,2013-10-16,NA,Y +01-714-1195,4,2013-05-14,19,NA,NA,SOMNOLENCE,SOMNOLENCE,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,NA,Y +01-714-1195,5,2013-05-17,22,NA,NA,APPLICATION SITE PRURITUS,APPLICATION SITE PRURITUS,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,NA,Y +01-714-1195,6,2013-05-12,17,2013-07-17,83,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,99,Y +01-714-1195,7,2013-05-12,17,2013-07-17,83,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,99,Y +01-714-1195,8,2013-05-13,18,2013-07-17,83,APPLICATION SITE ERYTHEMA,APPLICATION SITE ERYTHEMA,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,99,Y +01-714-1195,9,2013-07-25,91,2013-08-06,103,DYSURIA,DYSURIA,RENAL AND URINARY DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,75,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-26,2013-10-23,79,Y +01-714-1288,1,2013-12-13,10,2013-12-13,10,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,187,Y +01-714-1288,2,2013-12-14,11,2013-12-15,12,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,185,Y +01-714-1288,3,2014-01-11,39,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,NA,Y +01-714-1288,4,2014-01-22,50,2014-01-25,53,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,144,Y +01-714-1288,5,2014-01-22,50,2014-01-25,53,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,144,Y +01-714-1288,7,2014-03-08,95,NA,NA,ARTHRALGIA,ARTHRALGIA,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,NA,Y +01-714-1288,8,2014-02-24,83,2014-04-08,126,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,71,Y +01-714-1288,9,2014-05-27,175,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,77,M,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-04,2014-06-17,NA,Y +01-714-1375,3,2013-03-30,33,2013-04-06,40,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,155,Y +01-714-1375,4,2013-04-04,38,2013-04-15,49,EAR PAIN,EAR PAIN,EAR AND LABYRINTH DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,146,Y +01-714-1375,5,2013-05-29,93,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,NA,Y +01-714-1375,6,2013-06-16,111,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,NA,Y +01-714-1375,7,2013-05-29,93,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,NA,Y +01-714-1375,8,2013-06-16,111,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,714,714,78,F,WHITE,Placebo,Pbo,ONGOING,2013-02-26,2013-09-07,NA,Y +01-714-1425,1,2013-08-13,-2,NA,NA,ATRIOVENTRICULAR BLOCK SECOND DEGREE,ATRIOVENTRICULAR BLOCK SECOND DEGREE,CARDIAC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,714,714,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-08-15,2013-08-22,NA,Y +01-715-1107,2,2013-05-13,77,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,715,715,65,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-26,2013-05-13,NA,Y +01-715-1107,3,2013-05-07,71,2013-05-21,85,DERMATITIS CONTACT,DERMATITIS CONTACT,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,715,715,65,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-26,2013-05-13,-8,Y +01-715-1207,1,2013-01-10,54,2013-01-10,54,NEPHROLITHIASIS,NEPHROLITHIASIS,RENAL AND URINARY DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,715,715,78,F,WHITE,Placebo,Pbo,ONGOING,2012-11-18,2013-06-01,143,Y +01-715-1319,1,2013-03-18,30,2013-03-18,30,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,715,715,65,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-17,2013-03-18,0,Y +01-715-1321,2,2014-03-14,32,2014-03-14,32,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,715,715,75,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-11,2014-04-22,40,Y +01-715-1321,3,2014-04-21,70,NA,NA,APPLICATION SITE REACTION,APPLICATION SITE REACTION,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,715,715,75,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-11,2014-04-22,NA,Y +01-715-1321,4,2014-04-22,71,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,715,715,75,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-02-11,2014-04-22,NA,Y +01-715-1405,1,2013-07-08,3,2013-07-08,3,PALPITATIONS,PALPITATIONS,CARDIAC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,715,715,69,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-06,2013-07-13,6,Y +01-715-1405,2,2013-07-08,3,2013-07-08,3,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,715,715,69,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-06,2013-07-13,6,Y +01-715-1405,3,2013-07-08,3,2013-07-08,3,DIZZINESS,DIZZINESS,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,715,715,69,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-06,2013-07-13,6,Y +01-715-1405,4,2013-07-08,3,2013-07-08,3,CONFUSIONAL STATE,CONFUSIONAL STATE,PSYCHIATRIC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,715,715,69,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-06,2013-07-13,6,Y +01-715-1405,6,2013-07-13,8,2013-07-13,8,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,715,715,69,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-07-06,2013-07-13,0,Y +01-716-1024,2,2012-08-20,43,2012-09-27,81,NASOPHARYNGITIS,NASOPHARYNGITIS,INFECTIONS AND INFESTATIONS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,716,716,87,F,WHITE,Placebo,Pbo,ONGOING,2012-07-09,2013-01-20,116,Y +01-716-1024,3,2012-12-16,161,NA,NA,EMPHYSEMA,EMPHYSEMA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,87,F,WHITE,Placebo,Pbo,ONGOING,2012-07-09,2013-01-20,NA,Y +01-716-1026,1,2014-04-17,16,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,NA,Y +01-716-1026,2,2014-04-17,16,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,NA,Y +01-716-1026,4,2014-07-16,106,2014-07-25,115,EAR INFECTION,EAR INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,84,Y +01-716-1026,5,2014-07-31,121,NA,NA,ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED,ELECTROCARDIOGRAM T WAVE AMPLITUDE DECREASED,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,NA,Y +01-716-1026,6,2014-04-18,17,2014-07-31,121,ELECTROCARDIOGRAM T WAVE INVERSION,ELECTROCARDIOGRAM T WAVE INVERSION,INVESTIGATIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,78,Y +01-716-1026,7,2014-08-15,136,2014-08-27,148,EAR INFECTION,EAR INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,716,716,73,F,WHITE,Placebo,Pbo,ONGOING,2014-04-02,2014-10-16,51,Y +01-716-1044,2,2013-05-21,25,2013-05-26,30,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,74,M,WHITE,Placebo,Pbo,ONGOING,2013-04-27,2013-11-03,162,Y +01-716-1044,3,2013-10-15,172,NA,NA,CONFUSIONAL STATE,CONFUSIONAL STATE,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,74,M,WHITE,Placebo,Pbo,ONGOING,2013-04-27,2013-11-03,NA,Y +01-716-1063,1,2013-05-09,1,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,80,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-08-28,NA,Y +01-716-1063,2,2013-07-01,54,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,80,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-08-28,NA,Y +01-716-1063,4,2013-07-04,57,2013-07-28,81,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-08-28,32,Y +01-716-1063,6,2013-07-31,84,NA,NA,LETHARGY,LETHARGY,NERVOUS SYSTEM DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,80,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-08-28,NA,Y +01-716-1063,7,2013-07-28,81,2013-07-31,84,RESTLESSNESS,RESTLESSNESS,PSYCHIATRIC DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-05-09,2013-08-28,29,Y +01-716-1071,1,2013-07-13,36,NA,NA,HYPERSOMNIA,HYPERSOMNIA,NERVOUS SYSTEM DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,78,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-08,2013-08-01,NA,Y +01-716-1071,2,2013-07-13,36,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,78,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-08,2013-08-01,NA,Y +01-716-1071,3,2013-07-31,54,2013-07-31,54,SYNCOPE,SYNCOPE,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,78,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-06-08,2013-08-01,2,Y +01-716-1094,1,2013-01-19,32,NA,NA,ATRIAL FLUTTER,ATRIAL FLUTTER,CARDIAC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-19,2013-01-26,NA,Y +01-716-1094,2,2013-01-19,32,NA,NA,BUNDLE BRANCH BLOCK RIGHT,BUNDLE BRANCH BLOCK RIGHT,CARDIAC DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-19,2013-01-26,NA,Y +01-716-1094,3,2013-01-19,32,NA,NA,VENTRICULAR SEPTAL DEFECT,VENTRICULAR SEPTAL DEFECT,"CONGENITAL, FAMILIAL AND GENETIC DISORDERS",N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,82,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-12-19,2013-01-26,NA,Y +01-716-1103,1,2014-07-09,112,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-20,2014-09-20,NA,Y +01-716-1103,2,2014-07-09,112,2014-07-16,119,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-20,2014-09-20,67,Y +01-716-1103,3,2014-07-09,112,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-20,2014-09-20,NA,Y +01-716-1103,5,2014-08-17,151,2014-08-24,158,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,SEVERE,Y,RECOVERED/RESOLVED,Y,Y,716,716,79,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-03-20,2014-09-20,28,Y +01-716-1108,1,2013-04-12,60,NA,NA,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,ELECTROCARDIOGRAM ST SEGMENT DEPRESSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,86,F,WHITE,Placebo,Pbo,ONGOING,2013-02-12,2013-08-10,NA,Y +01-716-1108,2,2013-05-01,79,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,86,F,WHITE,Placebo,Pbo,ONGOING,2013-02-12,2013-08-10,NA,Y +01-716-1151,2,2013-03-15,43,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-01,2013-06-07,NA,Y +01-716-1151,3,2013-03-15,43,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-01,2013-06-07,NA,Y +01-716-1151,4,2013-02-19,19,2013-03-22,50,MALIGNANT FIBROUS HISTIOCYTOMA,MALIGNANT FIBROUS HISTIOCYTOMA,"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)",N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,716,716,83,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-02-01,2013-06-07,78,Y +01-716-1157,2,2013-10-25,24,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,85,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-10-02,2014-04-05,NA,Y +01-716-1157,3,2013-10-25,24,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,85,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-10-02,2014-04-05,NA,Y +01-716-1157,4,2013-10-17,16,2013-11-04,34,UPPER RESPIRATORY TRACT INFECTION,UPPER RESPIRATORY TRACT INFECTION,INFECTIONS AND INFESTATIONS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,716,716,85,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-10-02,2014-04-05,153,Y +01-716-1160,1,2013-05-09,35,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,83,F,WHITE,Placebo,Pbo,ONGOING,2013-04-05,2013-10-11,NA,Y +01-716-1160,2,2013-05-09,35,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,83,F,WHITE,Placebo,Pbo,ONGOING,2013-04-05,2013-10-11,NA,Y +01-716-1167,1,2012-11-17,41,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-08,2013-04-13,NA,Y +01-716-1167,2,2012-11-17,41,NA,NA,SWELLING,SWELLING,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-08,2013-04-13,NA,Y +01-716-1167,3,2012-12-03,57,NA,NA,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-08,2013-04-13,NA,Y +01-716-1167,5,2013-03-10,154,2013-04-10,185,HYPERSENSITIVITY,HYPERSENSITIVITY,IMMUNE SYSTEM DISORDERS,N,N,MILD,N,RECOVERED/RESOLVED,Y,Y,716,716,68,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2012-10-08,2013-04-13,4,Y +01-716-1177,1,2014-08-24,-9,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,716,716,72,M,WHITE,Placebo,Pbo,ONGOING,2014-09-02,2015-03-05,NA,Y +01-716-1189,1,2012-11-24,47,NA,NA,HALLUCINATION,HALLUCINATION,PSYCHIATRIC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-09,2013-03-03,NA,Y +01-716-1189,2,2012-11-24,47,NA,NA,DELUSION,DELUSION,PSYCHIATRIC DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-09,2013-03-03,NA,Y +01-716-1189,3,2013-01-05,89,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-09,2013-03-03,NA,Y +01-716-1189,4,2013-02-07,122,NA,NA,PROSTATE CANCER,PROSTATE CANCER,"NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)",N,Y,SEVERE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,81,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-10-09,2013-03-03,NA,Y +01-716-1229,1,2013-02-20,1,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,73,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-20,2013-04-02,NA,Y +01-716-1229,2,2013-03-06,15,NA,NA,BLOOD CHOLESTEROL INCREASED,BLOOD CHOLESTEROL INCREASED,INVESTIGATIONS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,73,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-02-20,2013-04-02,NA,Y +01-716-1298,4,2013-04-22,15,2013-07-06,90,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-08,2013-07-06,0,Y +01-716-1298,5,2013-04-22,15,2013-07-06,90,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-08,2013-07-06,0,Y +01-716-1298,6,2013-06-08,62,2013-07-06,90,BLISTER,BLISTER,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,76,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2013-04-08,2013-07-06,0,Y +01-716-1308,1,2013-09-20,24,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,76,F,WHITE,Placebo,Pbo,ONGOING,2013-08-28,2013-10-07,NA,Y +01-716-1311,2,2014-07-22,70,2014-08-02,81,ABDOMINAL PAIN,ABDOMINAL PAIN,GASTROINTESTINAL DISORDERS,N,N,MODERATE,N,RECOVERED/RESOLVED,Y,Y,716,716,78,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-14,2014-09-30,60,Y +01-716-1311,3,2014-08-02,81,NA,NA,ULCER,ULCER,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,78,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-14,2014-09-30,NA,Y +01-716-1311,4,2014-05-28,15,2014-09-22,132,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,78,M,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-05-14,2014-09-30,9,Y +01-716-1364,1,2013-08-18,46,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-07-04,2014-01-09,NA,Y +01-716-1364,2,2013-09-02,61,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,84,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-07-04,2014-01-09,NA,Y +01-716-1373,1,2012-12-14,1,NA,NA,COGNITIVE DISORDER,COGNITIVE DISORDER,NERVOUS SYSTEM DISORDERS,N,Y,MILD,N,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,74,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-14,2013-02-28,NA,Y +01-716-1373,2,2012-12-15,2,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,74,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-14,2013-02-28,NA,Y +01-716-1418,2,2013-05-05,1,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,NA,Y +01-716-1418,3,2013-05-05,1,2013-05-07,3,URTICARIA,URTICARIA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,198,Y +01-716-1418,4,2013-05-07,3,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,NA,Y +01-716-1418,7,NA,NA,2013-09-26,145,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,56,Y +01-716-1418,8,NA,NA,2013-10-04,153,VISION BLURRED,VISION BLURRED,EYE DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,48,Y +01-716-1418,10,2013-09-26,145,2013-11-11,191,HEADACHE,HEADACHE,NERVOUS SYSTEM DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,80,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-05-05,2013-11-20,10,Y +01-716-1441,1,2014-05-11,110,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,85,M,WHITE,Placebo,Pbo,ONGOING,2014-01-22,2014-07-22,NA,Y +01-716-1447,1,2014-01-01,17,NA,NA,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-17,NA,Y +01-716-1447,2,2014-01-14,30,NA,NA,ERYTHEMA,ERYTHEMA,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-17,NA,Y +01-716-1447,3,2014-01-14,30,NA,NA,PRURITUS,PRURITUS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-17,NA,Y +01-716-1447,4,2014-03-14,89,NA,NA,ELECTROCARDIOGRAM T WAVE INVERSION,ELECTROCARDIOGRAM T WAVE INVERSION,INVESTIGATIONS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,716,716,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-17,NA,Y +01-716-1447,5,2014-04-05,111,2014-04-09,115,CHEST PAIN,CHEST PAIN,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,716,716,72,F,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2013-12-16,2014-06-17,70,Y +01-717-1004,1,NA,NA,NA,NA,ENURESIS,ENURESIS,RENAL AND URINARY DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,1,NA,NA,NA,NA,ENURESIS,ENURESIS,RENAL AND URINARY DISORDERS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,5,2014-01-15,2,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,5,2014-01-15,2,NA,NA,FATIGUE,FATIGUE,GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS,N,Y,MODERATE,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,7,2014-01-15,2,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,7,2014-01-15,2,NA,NA,ANXIETY,ANXIETY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,8,2014-01-15,2,NA,NA,IRRITABILITY,IRRITABILITY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,8,2014-01-15,2,NA,NA,IRRITABILITY,IRRITABILITY,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,9,2014-01-15,2,2014-02-08,26,RHINORRHOEA,RHINORRHOEA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,159,Y +01-717-1004,9,2014-01-15,2,2014-02-08,26,RHINORRHOEA,RHINORRHOEA,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,159,Y +01-717-1004,10,2014-01-13,-1,2014-02-10,28,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,157,Y +01-717-1004,10,2014-01-13,-1,2014-02-10,28,DIARRHOEA,DIARRHOEA,GASTROINTESTINAL DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,157,Y +01-717-1004,11,2014-01-15,2,2014-02-09,27,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,158,Y +01-717-1004,11,2014-01-15,2,2014-02-09,27,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,158,Y +01-717-1004,12,2014-01-15,2,2014-02-18,36,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MODERATE,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,149,Y +01-717-1004,12,2014-01-15,2,2014-02-18,36,COUGH,COUGH,"RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS",N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,149,Y +01-717-1004,14,2014-03-09,55,2014-03-15,61,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,124,Y +01-717-1004,14,2014-03-09,55,2014-03-15,61,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,124,Y +01-717-1004,15,2014-04-08,85,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,15,2014-04-08,85,NA,NA,SINUS BRADYCARDIA,SINUS BRADYCARDIA,CARDIAC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,16,2014-04-21,98,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,16,2014-04-21,98,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,17,2014-05-21,128,NA,NA,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,17,2014-05-21,128,NA,NA,BACK PAIN,BACK PAIN,MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS,N,Y,MODERATE,N,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,NA,Y +01-717-1004,19,2014-06-03,141,2014-06-10,148,WOUND,WOUND,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,Y,RECOVERED/RESOLVED,N,N,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,37,Y +01-717-1004,19,2014-06-03,141,2014-06-10,148,WOUND,WOUND,"INJURY, POISONING AND PROCEDURAL COMPLICATIONS",N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,80,F,WHITE,Xanomeline Low Dose,Xan_Lo,ONGOING,2014-01-14,2014-07-16,37,Y +01-717-1109,2,2014-02-15,20,NA,NA,SKIN IRRITATION,SKIN IRRITATION,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-27,2014-07-28,NA,Y +01-717-1109,3,2014-02-15,20,2014-02-17,22,HYPERHIDROSIS,HYPERHIDROSIS,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,N,MILD,Y,RECOVERED/RESOLVED,Y,Y,717,717,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-27,2014-07-28,162,Y +01-717-1109,4,2014-02-20,25,NA,NA,CONFUSIONAL STATE,CONFUSIONAL STATE,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-27,2014-07-28,NA,Y +01-717-1109,5,2014-02-22,27,NA,NA,INSOMNIA,INSOMNIA,PSYCHIATRIC DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-27,2014-07-28,NA,Y +01-717-1109,6,2014-03-04,37,NA,NA,PRURITUS GENERALISED,PRURITUS GENERALISED,SKIN AND SUBCUTANEOUS TISSUE DISORDERS,N,Y,MILD,Y,NOT RECOVERED/NOT RESOLVED,Y,Y,717,717,84,M,WHITE,Xanomeline High Dose,Xan_Hi,ONGOING,2014-01-27,2014-07-28,NA,Y +01-717-1109,7,2014-04-18,82,NA,NA,VENTRICULAR EXTRASYSTOLES,VENTRICULAR EXTRASYSTOLES,CARDIAC 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Dose,Xan_Hi,ONGOING,2012-12-17,2013-02-18,NA,Y +01-718-1427,15,2013-02-04,50,2013-02-25,71,DECREASED APPETITE,DECREASED APPETITE,METABOLISM AND NUTRITION DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,718,718,74,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-17,2013-02-18,-7,Y +01-718-1427,16,2013-02-04,50,2013-02-25,71,NAUSEA,NAUSEA,GASTROINTESTINAL DISORDERS,N,N,MODERATE,Y,RECOVERED/RESOLVED,Y,Y,718,718,74,F,BLACK OR AFRICAN AMERICAN,Xanomeline High Dose,Xan_Hi,ONGOING,2012-12-17,2013-02-18,-7,Y diff --git a/global.R b/global.R index 1db4a7f..3176fe0 100644 --- a/global.R +++ b/global.R @@ -1,51 +1,53 @@ -################################################################################ -# global.R -# This R Script declares the required packages for loading the Shiny App, links -# other R Scripts with global objects and defines global variables and functions. -################################################################################ - -### Declaration of required packages for running the Shiny App smoothly -------- -library(shiny) # version: 1.4.0 -library(shinyjs) # version: 1.1 -library(data.table) # version: 1.12.8 -library(DT) # version: 0.12 -library(ggplot2) # version: 3.2.1 -library(plotly) # version: 4.9.1 -library(scales) # version: 1.1.0 -library(shinycssloaders) # version: 0.3 -library(conflicted) # version: 1.0.4 -library(dplyr) # version: 0.8.3 -library(tidyr) # version: 1.0.2 -library(survival) # version: 3.1-8 -library(survminer) # version: 0.4.6 -library(fmsb) # version: 0.7.0 - -conflict_prefer("first", "dplyr") -conflict_prefer("filter", "dplyr") -# conflict_prefer("layout", "plotly") -# conflict_prefer("hidden", "shinyjs") -# conflict_prefer("dataTableOutput", "DT") - - -### Source any R Scripts other than ui.R, server.R and global.R ---------------- -source("volcano_plot.R") -source("GetStatistics.R") - - -### Definitions of global variables and functions ------------------------------ -# Check that it doesn't match any non-number -numbers_only <- function(x) !grepl("\\D", x) - -fmt_dcimals <- function(decimals = 0) { - function(x) format(x, nsmall = decimals, scientific = FALSE) -} - -reverselog_trans <- function(base = exp(1)) { - trans <- function(x) -log(x, base) - inv <- function(x) base^(-x) - trans_new(paste0("reverselog-", format(base)), trans, inv, - log_breaks(base = base), - domain = c(1e-100, Inf)) -} - - +################################################################################ +# global.R +# This R Script declares the required packages for loading the Shiny App, links +# other R Scripts with global objects and defines global variables and functions. +################################################################################ + +### Declaration of required packages for running the Shiny App smoothly -------- +library(shiny) # version: 1.4.0 +library(shinyjs) # version: 1.1 +library(data.table) # version: 1.12.8 +library(DT) # version: 0.12 +library(ggplot2) # version: 3.2.1 +library(plotly) # version: 4.9.1 +library(scales) # version: 1.1.0 +library(shinycssloaders) # version: 0.3 +library(conflicted) # version: 1.0.4 +library(dplyr) # version: 0.8.3 +library(tidyr) # version: 1.0.2 +library(survival) # version: 3.1-8 +library(survminer) # version: 0.4.6 +library(fmsb) # version: 0.7.0 +library(shinyWidgets) +library(cowplot) +# if function conflicts, default dplyr +conflict_prefer("first", "dplyr") +select <- dplyr::select; rename <- dplyr::rename; mutate <- dplyr::mutate; summarize <- dplyr::summarize; arrange <- dplyr::arrange; slice <- dplyr::slice; filter <- dplyr::filter; recode<-dplyr::recode +style <- plotly::style +# conflict_prefer("layout", "plotly") +# conflict_prefer("hidden", "shinyjs") +# conflict_prefer("dataTableOutput", "DT") + + +### Source any R Scripts other than ui.R, server.R and global.R ---------------- +source("volcano_plot.R") +source("GetStatistics.R") + + +### Definitions of global variables and functions ------------------------------ +# Check that it doesn't match any non-number +numbers_only <- function(x) !grepl("\\D", x) + +# fmt_dcimals <- function(decimals = 0) { +# function(x) format(x, nsmall = decimals, scientific = FALSE) +# } + +reverselog_trans <- function(base = exp(1)) { + trans <- function(x) -log(x, base) + inv <- function(x) base^(-x) + trans_new(paste0("reverselog-", format(base)), trans, inv, + log_breaks(base = base), + domain = c(1e-100, Inf)) +} + diff --git a/server.R b/server.R index 55a997b..20b5dbf 100644 --- a/server.R +++ b/server.R @@ -1,828 +1,399 @@ -################################################################################ -# server.R -# This R Script defines the server logics for the Shiny App. -################################################################################ - -server <- function(input, output, session) { - - data <- reactiveValues(ae_test = NULL, - statistics = NULL, - statistics_soc = NULL) - - plots <- reactiveValues(volcano_plot_data = NULL, - volcano_plot = NULL, - volcano_plot_click = NULL) - - ### Data uploading ----------------------------------------------------------- - ae_test_data <- reactive({ - file <- input$file_ae_test - if (is.null(file)) return() - df <- fread(input$file_ae_test$datapath) - }) - - statistics_data <- reactive({ - file <- input$file_statistics - if (is.null(file)) return() - df <- fread(input$file_statistics$datapath) - }) - - observe({ - if (!is.null(ae_test_data())) { - data$ae_test <- ae_test_data() - } - # if (is.null(data$ae_test)){ - # filename <- paste0(getwd(),"/ae-test.csv") - # if(file.exists(filename)){ - # data$ae_test <- fread(filename) - # } else { - # shinyjs::alert(paste0("SDTM file does not exist:",filename)) - # } - # } - }) - - - ### Extract all arms --------------------------------------------------------- - ARMCD <- reactive({ - req(data$ae_test) - unique(data$ae_test$ARMCD) - }) - - - ### Definitions of UI outputs in the control panel and related logics -------- - output$summary_by_UI <- renderUI({ - req(data$ae_test) - selectInput("summary_by", "Summary By", - choices = c("Patients", "Events"), multiple = F) - }) - - output$review_by_UI <- renderUI({ - req(data$ae_test) - selectInput("review_by", "Review By", - choices = c("PT", "SOC", "Other"), multiple = F) - }) - - output$review_by_please_specify_UI <- renderUI({ - req(data$ae_test) - req(input$review_by) - if (input$review_by != "Other") return() - textInput("review_by_please_specify", "Please specify") - }) - - output$period_UI <- renderUI({ - req(data$ae_test) - selectInput("period", "Period", - choices = c("Treatment emergent", "AE during entire study", "Other"), multiple = F) - }) - - output$period_please_specify_UI <- renderUI({ - req(data$ae_test) - req(input$period) - if (input$period != "Other") return() - numericInput("period_please_specify", - HTML("Please enter residual period (in days)"), - value = 30, min = 0, max = 10^5) - }) - - output$ser_UI <- renderUI({ - req(data$ae_test) - checkboxInput("ser", "Serious adverse event", value = FALSE) - }) - - output$drug_UI <- renderUI({ - req(data$ae_test) - checkboxInput("drug", "Drug-related adverse events", value = FALSE) - }) - - output$test_UI <- renderUI({ - req(data$ae_test) - selectInput("test", "Measure of Association", - choices = c("Rate Ratio", - "Risk Ratio", - "Hazard Ratio", - "Risk Difference", - "Rate Difference"), - multiple = F) - }) - - output$treatment1_UI <- renderUI({ - req(data$ae_test) - req(ARMCD()) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - div(style = 'height:100px; width:91%; overflow: scroll', - checkboxGroupInput("treatment1", "Exposed Group", - choices = ARMCD(), - selected = ARMCD()[1], - inline = F) - ) - }) - - output$treatment2_UI <- renderUI({ - req(data$ae_test) - req(ARMCD()) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - div(style = 'height:100px; width:91%; overflow: scroll', - checkboxGroupInput("treatment2", "Unexposed Group", - choices = setdiff(ARMCD(), input$treatment1), - selected = setdiff(ARMCD(), input$treatment1)[1], - inline = F) - ) - }) - - output$treatment1_label_UI <- renderUI({ - req(data$ae_test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - textInput("treatment1_label", "Label for Exposed Group") - }) - - output$treatment2_label_UI <- renderUI({ - req(data$ae_test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - textInput("treatment2_label", "Label for Unexposed Group") - }) - - subgroup_var_choices <- reactive({ - req(data$ae_test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - c("No Subgroup Variable", colnames(data$ae_test)) - }) - - output$subgroup_var_UI <- renderUI({ - req(data$ae_test) - req(subgroup_var_choices()) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - selectInput("subgroup_var", "Subgroup Variable", - # choices = subgroup_var_choices(), - choices = c("No Subgroup Variable", "SITE", "SEX", "RACE"), - selected = NULL, multiple = F) - }) - - output$subgroup_vals_title_UI <- renderUI({ - req(input$subgroup_var) - if(input$subgroup_var == "No Subgroup Variable") return() - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - h5(strong("Value for Subgroup")) - }) - - output$subgroup_vals_UI <- renderUI({ - req(input$subgroup_var) - if(input$subgroup_var == "No Subgroup Variable") return() - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - req(data$ae_test) - div(style = 'height:200px; width:91%; overflow: scroll', - checkboxGroupInput("subgroup_vals", "", - choices = sort(unique(data$ae_test[[input$subgroup_var]])), - inline = F) - ) - }) - - output$X_ref_UI <- renderUI({ - req(data$ae_test) - req(input$test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - if (input$test %in% c("Hazard Ratio", "Rate Ratio", "Risk Ratio")) {xref <- 1} - if (input$test %in% c("Rate Difference", "Risk Difference")) {xref <- 0} - textInput("X_ref", "X-axis Reference Line", value = xref) - }) - - output$Y_ref_UI <- renderUI({ - req(data$ae_test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - textInput("Y_ref", "Y-axis Reference Line", value = 0.05) - }) - - output$pvalue_option_UI <- renderUI({ - req(data$ae_test) - if(input$summary_by == "Events" & input$test %in% c("Hazard Ratio", - "Rate Difference", - "Rate Ratio", - "Risk Difference", - "Risk Ratio")) return() - selectInput("pvalue_option", "p-Value Option", - choices = c("Unadjusted", "Adjusted"), multiple = F) - }) - - - ### An essential step for obtaining statistics right after data uploading and - ### before the generation of volcano plot ------------------------------------ - observeEvent(input$obtain, { - req(input$review_by) - req(input$summary_by) - req(input$treatment1) - req(input$treatment2) - if (input$period == "Other") {req(input$period_please_specify)} - if (input$review_by == "SOC") return() - if (!is.null(statistics_data())) { - data$statistics <- statistics_data() - } - # if (is.null(data$statistics)){ - # filename <- paste0(getwd(),"/statistics.csv") - # if(file.exists(filename)){ - # data$statistics <- fread(filename) - # } else { - # shinyjs::alert(paste0("ADaM file does not exist:",filename)) - # } - # } - if (is.null(ae_test_data())) { - shinyjs::alert("Please import a SDTM dataset first!") - data$statistics <- NULL - } else { - if (input$summary_by == "Events" & input$test == "Hazard Ratio") { - data$statistics <- NULL - shinyjs::alert(paste0("Error: Hazard Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Rate Difference") { - data$statistics <- NULL - shinyjs::alert(paste0("Error: Rate Difference cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Rate Ratio") { - data$statistics <- NULL - shinyjs::alert(paste0("Error: Rate Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Risk Difference") { - data$statistics <- NULL - shinyjs::alert(paste0("Error: Risk Difference cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Risk Ratio") { - data$statistics <- NULL - shinyjs::alert(paste0("Error: Risk Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Patients" & input$test == "Hazard Ratio") { - withProgress(data$statistics <- GetStatistics_HazardR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - FALSE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Rate Difference") { - withProgress(data$statistics <- GetStatistics_RateD(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - FALSE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Rate Ratio") { - withProgress(data$statistics <- GetStatistics_RateR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - FALSE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Risk Difference") { - withProgress(data$statistics <- GetStatistics_RiskD(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - FALSE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Risk Ratio") { - withProgress(data$statistics <- GetStatistics_RiskR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - FALSE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - } - }) - - observeEvent(input$obtain, { - req(input$review_by) - req(input$summary_by) - if (input$period == "Other") {req(input$period_please_specify)} - if (input$review_by!="SOC") return() - if (!is.null(statistics_data())) { - data$statistics_soc <- statistics_data() - } - # if (is.null(data$statistics_soc)){ - # filename <- paste0(getwd(),"/statistics-soc.csv") - # if(file.exists(filename)){ - # data$statistics_soc <- fread(filename) - # } else { - # shinyjs::alert(paste0("ADaM file does not exist:",filename)) - # } - # } - if (is.null(ae_test_data())) { - shinyjs::alert("Please import a SDTM dataset first!") - data$statistics_soc <- NULL - } else { - if (input$summary_by == "Events" & input$test == "Hazard Ratio") { - data$statistics_soc <- NULL - shinyjs::alert(paste0("Error: Hazard Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Rate Difference") { - data$statistics_soc <- NULL - shinyjs::alert(paste0("Error: Rate Difference cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Rate Ratio") { - data$statistics_soc <- NULL - shinyjs::alert(paste0("Error: Rate Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Risk Difference") { - data$statistics_soc <- NULL - shinyjs::alert(paste0("Error: Risk Difference cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Events" & input$test == "Risk Ratio") { - data$statistics_soc <- NULL - shinyjs::alert(paste0("Error: Risk Ratio cannot be obtained ", - "if data is summarized by events instead of patients!")) - } - if (input$summary_by == "Patients" & input$test == "Hazard Ratio") { - withProgress(data$statistics_soc <- GetStatistics_HazardR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - TRUE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Rate Difference") { - withProgress(data$statistics_soc <- GetStatistics_RateD(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - TRUE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Rate Ratio") { - withProgress(data$statistics_soc <- GetStatistics_RateR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - TRUE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Risk Difference") { - withProgress(data$statistics_soc <- GetStatistics_RiskD(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - TRUE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - if (input$summary_by == "Patients" & input$test == "Risk Ratio") { - withProgress(data$statistics_soc <- GetStatistics_RiskR(ae_test_data(), - input$ser, - input$drug, - input$period, - ifelse(input$period != "Other", - NULL, input$period_please_specify), - TRUE, - input$treatment1, - input$treatment2), - message = "Executing data pre-processing...", - detail = "This step should take a while.", - min = 0, max = 1, value = 1) - } - } - }) - - - ### Definition of 'Reset' button UI output and its consequent triggerings ---- - output$reset_UI <- renderUI({ - req(data$ae_test) - actionButton("reset", "Reset") - }) - - observeEvent(input$reset, { - updateSelectInput(session, "summary_by", "Summary By", - choices = c("Patients", "Events")) - updateSelectInput(session, "review_by", "Review By", - choices = c("PT", "SOC", "Other")) - updateSelectInput(session, "period", "Period", - choices = c("Treatment emergent", - "AE during entire study", - "Other")) - updateCheckboxInput(session, "ser", "Serious adverse event", value = FALSE) - updateCheckboxInput(session, "drug", "Drug-related adverse events", value = FALSE) - updateSelectInput(session, "test", "Measure of Association", - choices = c("Rate Ratio", - "Risk Ratio", - "Hazard Ratio", - "Risk Difference", - "Rate Difference")) - updateCheckboxGroupInput(session, "treatment1", "Exposed Group", - choices = ARMCD(), selected = ARMCD()[1], inline = F) - updateCheckboxGroupInput(session, "treatment2", "Unexposed Group", - choices = setdiff(ARMCD(), input$treatment1), - selected = setdiff(ARMCD(), input$treatment1)[1], - inline = F) - updateTextInput(session, "treatment1_label", "Label for Exposed Group") - updateTextInput(session, "treatment2_label", "Label for Unexposed Group") - updateSelectInput(session, "subgroup_var", "Subgroup Variable", - choices = c("No Subgroup Variable", "SITE", "AGE", "SEX", "RACE"), - selected = NULL) - updateTextInput(session, "X_ref", "X-axis Reference Line", value = 1) - updateTextInput(session, "Y_ref", "Y-axis Reference Line", value = 0.05) - updateSelectInput(session, "pvalue_option", "p-Value Option", - choices = c("Unadjusted", "Adjusted")) - }) - - - ### Definition of 'Obtain Statistics' button UI output ----------------------- - output$obtain_UI <- renderUI({ - req(data$ae_test) - actionButton("obtain", "Obtain Statistics") - }) - - - ### Definition of 'Update Plot' button UI output ----------------------------- - output$update_UI <- renderUI({ - req(data$ae_test) - if (input$review_by == "PT") {req(data$statistics)} - if (input$review_by == "SOC") {req(data$statistics_soc)} - actionButton("update", "Update Plot") - }) - - - ### Check the prerequisite of customized labels for exposed/unexposed group -- - observeEvent(input$update, { - if(nchar(input$treatment1_label) == 0) { - shinyjs::alert("Please enter label for the exposed group.") - return() - } - - if(nchar(input$treatment2_label) == 0) { - shinyjs::alert("Please enter label for the unexposed group.") - return() - } - }) - - - ### Generation of volcano plot ----------------------------------------------- - observeEvent(c(input$update - # input$review_by, - # input$review_by_please_specify, - # input$period, - # input$period_please_specify, - # input$ser, - # input$drug, - # input$test, - # input$treatment1, - # input$treatment2, - # input$treatment1_label, - # input$treatment2_label, - # input$subgroup_var, - # input$subgroup_vals, - # input$X_ref, - # input$Y_ref, - # input$pvalue_option - ), { - req(data$ae_test) - if (input$review_by == "PT") {req(data$statistics)} - if (input$review_by == "SOC") {req(data$statistics_soc)} - req(input$treatment1_label) - req(input$treatment2_label) - - if(length(input$treatment1) == 0) { - shinyjs::alert("Please select an exposed group.") - return() - } - - if(length(input$treatment2) == 0) { - shinyjs::alert("Please select an unexposed group.") - return() - } - - # if(length(input$period_please_specify)>0) { - # if(!numbers_only(input$period_please_specify)) { - # shinyjs::alert("Please enter only an integer for risk period.") - # return() - # } - # } - - if(length(input$X_ref) > 0) { - X_ref <- as.numeric(input$X_ref) - if(is.na(X_ref)) { - shinyjs::alert("Please enter a numeric value for X-axis reference line.") - return() - } - } - - if(length(input$Y_ref) > 0) { - Y_ref <- as.numeric(input$Y_ref) - if(is.na(Y_ref)) { - shinyjs::alert("Please enter a numeric value for Y-axis reference line.") - return() - } else { - if (!(as.numeric(input$Y_ref) >= 0 & as.numeric(input$Y_ref) <= 1)) { - shinyjs::alert("Please enter a valid value between 0 and 1 for Y-axis reference line.") - return() - } - } - } - - plots$volcano_plot <- NULL - plots$volcano_plot_data <- NULL - plots$volcano_plot_click <- NULL - withProgress(message = 'Plotting data', value = 0, { - out <- try( - volcano.plot( - data = isolate(data$ae_test), - statistics_data = isolate(data$statistics), - statistics_soc_data = isolate(data$statistics_soc), - ser = input$ser, - drug = input$drug, - period = input$period, - residual = input$period_please_specify, - test = input$test, - Treatment1 = input$treatment1, - Treatment2 = input$treatment2, - treatment1_label = input$treatment1_label, - treatment2_label = input$treatment2_label, - subgroup_var = input$subgroup_var, - subgroup_vals = input$subgroup_vals, - X_ref = as.numeric(input$X_ref), - Y_ref = as.numeric(input$Y_ref), - X_label = paste(input$test, input$treatment1_label, "vs", input$treatment2_label), - review_by = input$review_by, - summary_by = input$summary_by, - pvalue_option = input$pvalue_option) - ) - if (!"try-error" %in% class(p)) { - - tempdata <- data$ae_test %>% - mutate_at(names(data$ae_test)[!(names(data$ae_test) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data$ae_test), ~na_if(., "")) - - if (input$summary_by == "Patients") { - N1.total <- tempdata %>% - drop_na(RFSTDTC) %>% - filter(ARMCD %in% input$treatment1) %>% - distinct(USUBJID) %>% tally() %>% as.numeric() - - N2.total <- tempdata %>% - drop_na(RFSTDTC) %>% - filter(ARMCD %in% input$treatment2) %>% - distinct(USUBJID) %>% tally() %>% as.numeric() - } - - # if (input$summary_by == "Events") { - # N1.total <- tempdata %>% - # filter(!is.na(AESTDT) | !is.na(AEDECOD)) %>% - # filter(ARMCD %in% input$treatment1) %>% - # tally() %>% as.numeric() - # N2.total <- tempdata %>% - # filter(!is.na(AESTDT) | !is.na(AEDECOD)) %>% - # filter(ARMCD %in% input$treatment2) %>% - # tally() %>% as.numeric() - # } - - if (input$summary_by == "Patients") { - text1 <- paste0("<- Favors ", input$treatment1_label, - " n=", out$N1, " (N=", N1.total, ")") - text2 <- paste0("Favors ", input$treatment2_label, - " n=", out$N2, " (N=", N2.total, ") ->") - } else { - text1 <- paste0("<- Favors ", input$treatment1_label, - " (N=", N1.total, ")") - text2 <- paste0("Favors ", input$treatment2_label, - " (N=", N2.total, ") ->") - } - - plots$volcano_plot <- out$plot - plots$volcano_plot_data <- out$data - output$volcano_plot <- renderPlotly({ - ggplotly(plots$volcano_plot,tooltip = c("label")) %>% - plotly::layout(annotations = - list(x = 0, y = 0.02, text = text1, - showarrow = F, xref = 'paper', yref = 'paper', - xanchor = 'left', yanchor = 'bottom', xshift = 0, yshift = 0, - font = list(size = 15, color = "blue"))) %>% - plotly::layout(annotations = - list(x = .95, y = 0.02, text = text2, - showarrow = F, xref = 'paper', yref = 'paper', - xanchor = 'right', yanchor = 'bottom', xshift = 0, yshift = 0, - font = list(size = 15, color = "blue"))) - - }) - output$volcano_plot_UI <- renderUI({ - req(plots$volcano_plot) - # req(input$treatment1_label) - # req(input$treatment2_label) - plotlyOutput("volcano_plot", height = "625px") %>% withSpinner(type = 5) - }) - } else { - #Catch Error - plots$volcano_plot <- NULL - plots$volcano_plot_data <- NULL - shinyjs::alert("Error occurred processing the selected data.") - } - }) - }) - - - ### Definitions and logics for the drilldown table from click triggering ----- - observeEvent(event_data("plotly_click"), { - plots$volcano_plot_click <- event_data("plotly_click") - }) - - volcano_plot_table <- reactive({ - req(plots$volcano_plot_click) - plots$volcano_plot$data[as.numeric(plots$volcano_plot_click$key),] %>% - inner_join(plots$volcano_plot_data) %>% - select(USUBJID, - SITE, - AGE, - SEX, - RACE, - ARM, - SBJTSTAT, - AEBODSYS, - AEDECOD, - AESTDT, - AESTDY, - AEENDT, - AESER, - AEONGO, - AESEV, - AEREL, - AEOUT, - TRTEMFL, - STUDYFL) - }) - - #List the details of filtered data that matches the selected SOC/PT - output$volcano_plot_drill <- DT::renderDataTable({ - datatable(volcano_plot_table(), extensions = 'Buttons', - colnames = c('Subject ID', - 'Site', - 'Age', - 'Sex', - 'Race', - 'Treatment', - 'Subject Status', - 'SOC', - 'PT', - 'Onset Date', - 'Time to Onset', - 'End Date', - 'Serious AE?', - 'Still Ongoing?', - 'Severity', - 'Causality', - 'Outcome', - 'Treatment Emergent?', - 'During Entire Study?'), - options = list(dom = 'Bfrtip', - buttons = I('colvis'), - #buttons = c(I('colvis'), - # 'copy', - # 'csv', - # 'excel', - # 'print', - # 'pdf'), - pageLength = 10) - - - - ) - }, server = FALSE) - - output$volcano_plot_drill_UI <- renderUI({ - req(plots$volcano_plot_click) - DT::dataTableOutput("volcano_plot_drill") - }) - - - ### Specifications on the footnote of volcano plot --------------------------- - output$footnote_UI <- renderUI({ - req(plots$volcano_plot) - - # if (input$summary_by == "Events") { - # ft <- paste0(" Note:
", - # "* N is the total number of events.") - # } - - if (input$summary_by == "Patients") { - - if (input$ser == FALSE & input$drug == FALSE) { - ftn <- "* n is the number of patients with adverse events." - } - if (input$ser == TRUE & input$drug == FALSE) { - ftn <- "* n is the number of patients with serious adverse events." - } - if (input$ser == FALSE & input$drug == TRUE) { - ftn <- "* n is the number of patients with drug-related adverse events." - } - if (input$ser == TRUE & input$drug == TRUE) { - ftn <- "* n is the number of patients with serious adverse events and drug-related adverse events." - } - - ft <- paste0(" Note:
", - "* N is the total number of treated patients.
", - ftn) - } - - return(HTML(ft)) - }) -} - - +################################################################################ +# server.R +# This R Script defines the server logics for the Shiny App. +################################################################################ + +server <- function(input, output, session) { + + + data <- reactiveValues(ae_test = NULL, + statistics = NULL, + statistics_soc = NULL) + + plots <- reactiveValues(volcano_plot_data = NULL, + volcano_plot = NULL, + volcano_plot_click = NULL) + + ### Data uploading ----------------------------------------------------------- + ae_test_data <- reactive({ + # SDTM + file <- input$file_ae_test + if (is.null(file)) return() + df <- fread(input$file_ae_test$datapath)%>% as.data.frame() %>% + mutate(AESTDT = as.Date(AESTDT), AEENDT = as.Date(AEENDT), RFSTDTC = as.Date(RFSTDTC), RFENDTC = as.Date(RFENDTC)) + }) + + # what is statistics_data used for? + statistics_data <- reactive({ + file <- input$file_statistics + if (is.null(file)) return() + df <- fread(input$file_statistics$datapath) + }) + + # once data is loaded, all other inputs are loaded + output$fileUploaded <- reactive({ return(!is.null(ae_test_data())) }) + outputOptions(output, 'fileUploaded', suspendWhenHidden=FALSE) + + + observe({ + #only runs for SDTM + if (!is.null(ae_test_data())) { + data$ae_test <- ae_test_data() + } + }) + + + ### Extract all arms --------------------------------------------------------- + ARMCD <- reactive({ + req(data$ae_test) + unique(data$ae_test$ARMCD) + }) + + + ### Definitions of UI outputs in the control panel and related logics -------- + output$review_by_please_specify_UI <- renderUI({ + req(data$ae_test) + req(input$review_by) + if (input$review_by != "Other") return() + textInput("review_by_please_specify", "Please specify") + }) + + + output$period_please_specify_UI <- renderUI({ + req(data$ae_test) + req(input$period) + if (input$period != "Other") return() + numericInput("period_please_specify", + HTML("Please enter residual period (in days)"), + value = 30, min = 0, max = 10^5) + }) + + output$treatment1_UI <- renderUI({ + req(data$ae_test) + req(input$summary_by != "Events") + div(style = 'height:100px; width:91%; overflow: scroll', + checkboxGroupInput("treatment1", "Group A", + choices = ARMCD(), + selected = ARMCD()[1], + inline = F) + ) + }) + + output$treatment2_UI <- renderUI({ + req(data$ae_test) + req(input$summary_by != "Events") + div(style = 'height:100px; width:91%; overflow: scroll', + checkboxGroupInput("treatment2", "Group B", + choices = setdiff(ARMCD(), input$treatment1), + selected = setdiff(ARMCD(), input$treatment1)[1], + inline = F) + ) + }) + + output$treatment1_label_UI <- renderUI({ + req(data$ae_test) + req(input$summary_by != "Events") + textInput("treatment1_label", "Label for Group A", value="Exposed",width="75%") + }) + + output$treatment2_label_UI <- renderUI({ + req(data$ae_test) + req(input$summary_by != "Events") + textInput("treatment2_label", "Label for Group B",value="Unexposed",width="75%") + }) + + + + output$subgroup_vals_UI <- renderUI({ + if(input$subgroup_var == "No Subgroup Variable") return() + req(input$summary_by != "Events") + div(style = 'height:100px; width:91%; overflow: scroll', + checkboxGroupInput("subgroup_vals", "Value for Subgroup", + choices = sort(unique(data$ae_test[[input$subgroup_var]])), + inline = F) + ) + }) + + + ### An essential step for obtaining statistics right after data uploading and before the generation of volcano plot ------------------------------------ + observeEvent(input$obtain, { + req(input$treatment1) + req(input$treatment2) + if (input$period == "Other") {req(input$period_please_specify)} + if (input$review_by != "SOC"){ + if (!is.null(statistics_data())) { data$statistics <- statistics_data() } + else if(!is.null(statistics_data())) {data$statistics_soc <- statistics_data() } + } + + if (input$summary_by == "Events") { + data$statistics <- NULL + shinyjs::alert(paste0("Error: ",input$test, "cannot be obtained if data is summarized by events instead of patients!")) + } + + if (input$summary_by == "Patients"){ + if (input$review_by != "SOC"){ + + withProgress(data$statistics <- GetStatistics_all(data = ae_test_data(), + ae_filter = input$ae_filter, + period = input$period, + residual = ifelse(input$period != "Other",NULL, input$period_please_specify), + soc = FALSE, + treatment1= input$treatment1, + treatment2 = input$treatment2, + test = input$test + ), + message = "Executing data pre-processing...", + detail = "This step should take a while.", + min = 0, max = 1, value = 1) + } else if (input$review_by == "SOC"){ + + withProgress(data$statistics_soc <- GetStatistics_all(data = ae_test_data(), + ae_filter = input$ae_filter, + period = input$period, + residual = ifelse(input$period != "Other",NULL, input$period_please_specify), + soc = FALSE, + treatment1= input$treatment1, + treatment2 = input$treatment2, + test = input$test + ), + message = "Executing data pre-processing...", + detail = "This step should take a while.", + min = 0, max = 1, value = 1) + + + + } + } + + + + }) + + + ### Definition of 'Reset' button UI output and its consequent triggerings ---- + output$reset_UI <- renderUI({ + req(data$ae_test) + actionBttn("reset", "Reset Options",color = "primary",style = "bordered",block=TRUE) + }) + + + observeEvent(input$reset, { + updateSelectInput(session, "summary_by", "Summary By", choices = c("Patients", "Events")) + updateSelectInput(session, "review_by", "Review By", choices = c("PT", "SOC", "Other")) + updateSelectInput(session, "period", "Period", choices = c("Treatment emergent", "AE during entire study", "Other")) + updateCheckboxInput(session, "ser", "Serious adverse event", value = FALSE) + updateCheckboxInput(session, "drug", "Drug-related adverse events", value = FALSE) + updateSelectInput(session, "test", "Measure of Association", choices = c("Rate Ratio", "Risk Ratio", "Hazard Ratio", "Risk Difference", "Rate Difference")) + updateCheckboxGroupInput(session, "treatment1", "Group A", choices = ARMCD(), selected = ARMCD()[1], inline = F) + updateCheckboxGroupInput(session, "treatment2", "Group B", choices = setdiff(ARMCD(), input$treatment1), selected = setdiff(ARMCD(), input$treatment1)[1], inline = F) + updateTextInput(session, "treatment1_label", "Label for Group A") + updateTextInput(session, "treatment2_label", "Label for Group B") + updateSelectInput(session, "subgroup_var", "Subgroup Variable", choices = c("No Subgroup Variable", "SITE", "AGE", "SEX", "RACE"), selected = "No Subgroup Variable") + updatenumericInput(session, "X_ref", "X-axis Reference Line", value = 1) + updatenumericInput(session, "Y_ref", "Y-axis Reference Line", value = 0.05) + updateSelectInput(session, "pvalue_option", "p-Value Option", choices = c("Unadjusted", "Adjusted")) + }) + + + ### Definition of 'Obtain Statistics' button UI output ----------------------- + output$obtain_UI <- renderUI({ + req(data$ae_test) + actionBttn("obtain", "Obtain Statistics",color = "primary",style = "bordered",block=TRUE) + }) + + + ### Definition of 'Update Plot' button UI output ----------------------------- + output$update_UI <- renderUI({ + req(data$ae_test) + if (input$review_by == "PT") {req(data$statistics)} + if (input$review_by == "SOC") {req(data$statistics_soc)} + actionBttn("update", "Update Plot",color = "primary",style = "bordered",block=TRUE) + }) + + + + ### Generation of volcano plot ----------------------------------------------- + observeEvent(c(input$update + # input$X_ref, + # input$Y_ref, + # input$pvalue_option + ), { + req(data$ae_test) + if (input$review_by == "PT") {req(data$statistics)} + if (input$review_by == "SOC") {req(data$statistics_soc)} + req(input$treatment1_label) + req(input$treatment2_label) + + if(length(input$treatment1) == 0) { + shinyjs::alert("Please select Group A.") + return() + } + + if(length(input$treatment2) == 0) { + shinyjs::alert("Please select Group B.") + return() + } + + + plots$volcano_plot <- NULL + plots$volcano_plot_data <- NULL + withProgress(message = 'Plotting data', value = 0, { + out <- try( + volcano.plot( + data = isolate(data$ae_test), + statistics_data = isolate(data$statistics), + statistics_soc_data = isolate(data$statistics_soc), + ae_filter = input$ae_filter, + period = input$period, + residual = input$period_please_specify, + test = input$test, + treatment1 = input$treatment1, + treatment2 = input$treatment2, + subgroup_var = input$subgroup_var, + subgroup_vals = input$subgroup_vals, + X_ref = as.numeric(input$X_ref), + X_label = paste(input$test, input$treatment1_label, "vs.", input$treatment2_label), + review_by = input$review_by, + summary_by = input$summary_by, + pvalue_label = input$pvalue_label + ) + ) + if (!"try-error" %in% class(p)) { + + tempdata <- data$ae_test %>% + mutate_at(names(data$ae_test)[!(names(data$ae_test) %in% c("AESEQ", "AESTDY", "AEENDY", + "AGE", "RFENDY", "SAFFN"))], + ~as.character(.)) %>% + mutate_at(names(data$ae_test), ~na_if(., "")) + + if (input$summary_by == "Patients") { + N1.total <- tempdata %>% + drop_na(RFSTDTC) %>% + filter(ARMCD %in% input$treatment1) %>% + distinct(USUBJID) %>% tally() %>% as.numeric() + + N2.total <- tempdata %>% + drop_na(RFSTDTC) %>% + filter(ARMCD %in% input$treatment2) %>% + distinct(USUBJID) %>% tally() %>% as.numeric() + } + + # if (input$summary_by == "Events") { + # N1.total <- tempdata %>% + # filter(!is.na(AESTDT) | !is.na(AEDECOD)) %>% + # filter(ARMCD %in% input$treatment1) %>% + # tally() %>% as.numeric() + # N2.total <- tempdata %>% + # filter(!is.na(AESTDT) | !is.na(AEDECOD)) %>% + # filter(ARMCD %in% input$treatment2) %>% + # tally() %>% as.numeric() + # } + + if (input$summary_by == "Patients") { + text1 <- paste0("<- Favors ", input$treatment1_label, + " n=", out$N1, " (N=", N1.total, ")") + text2 <- paste0("Favors ", input$treatment2_label, + " n=", out$N2, " (N=", N2.total, ") ->") + } else { + text1 <- paste0("<- Favors ", input$treatment1_label, + " (N=", N1.total, ")") + text2 <- paste0("Favors ", input$treatment2_label, + " (N=", N2.total, ") ->") + } + + plots$volcano_plot <- out$plot + plots$volcano_plot_data <- out$data + output$volcano_plot <- renderPlotly({ + output = ggplotly(plots$volcano_plot,tooltip = c("label"), source="volcano_plot") %>% + plotly::layout(annotations = + list(x = 0, y = 0.02, text = text1, + showarrow = F, xref = 'paper', yref = 'paper', + xanchor = 'left', yanchor = 'bottom', xshift = 0, yshift = 0, + font = list(size = 12, color = "blue"))) %>% + plotly::layout(annotations = + list(x = .95, y = 0.02, text = text2, + showarrow = F, xref = 'paper', yref = 'paper', + xanchor = 'right', yanchor = 'bottom', xshift = 0, yshift = 0, + font = list(size = 12, color = "blue"))) + + output$x$layout$legend$font$size=8.5 # change legend text size + output + + }) + output$volcano_plot_UI <- renderUI({ + req(plots$volcano_plot) + plotlyOutput("volcano_plot", height = "650px") %>% withSpinner(type = 5) + }) + } else { + #Catch Error + plots$volcano_plot <- NULL + plots$volcano_plot_data <- NULL + shinyjs::alert("Error occurred processing the selected data.") + } + }) + }) + + + #List the details of filtered data that matches the selected SOC/PT + output$volcano_plot_drill <- DT::renderDataTable({ + s=event_data("plotly_click",source="volcano_plot") + req(length(s)>0) + + volcano_plot_table = plots$volcano_plot$data[as.numeric(s$key),] %>% + inner_join(plots$volcano_plot_data) %>% + select(USUBJID, SITE, AGE, SEX, RACE, ARM, SBJTSTAT, AEBODSYS, AEDECOD, AESTDT, AESTDY, AEENDT, AESER, AEONGO, + AESEV, AEREL, AEOUT,TRTEMFL, STUDYFL) + + datatable(volcano_plot_table, extensions = 'Buttons', + colnames = c('Subject ID', 'Site', 'Age', 'Sex', 'Race', 'Treatment', 'Subject Status', 'SOC', + 'PT', 'Onset Date', 'Time to Onset', 'End Date','Serious AE?','Still Ongoing?','Severity', + 'Causality','Outcome', 'Treatment Emergent?','During Entire Study?'), + options = list(dom = 'Bfrtip', buttons = I('colvis'), pageLength = 10) + ) + }, server = FALSE) + + + + ### Specifications on the footnote of volcano plot --------------------------- + output$footnote_UI <- renderText({ + req(plots$volcano_plot) + + if (input$summary_by == "Events") { + ft <- paste0(" Note:
", + "* N is the total number of events.
", + "Dashed horizontal line represents p-value of 0.05
", + "Dotted horizontal line represents FDR adjsuted p-value of approximately 0.05") + } + + if (input$summary_by == "Patients") { + if (is.null(input$ae_filter)){ + ftn = "* n is the number of patients with adverse events." + } else{ + + ae_filter_name = tolower(input$ae_filter) + if (length(ae_filter_name)<=1){ + ftn <- paste("* n is the number of patients with ",ae_filter_name,"adverse events.") + } + else if (length(ae_filter_name)>1){ + ftn <- paste0("* n is the number of patients with ",paste0(ae_filter_name[-length(ae_filter_name)],collapse=", "), " and ", ae_filter_name[length(ae_filter_name)], " adverse events.") + } + } + ft <- paste0(" Note:
", + "* N is the total number of treated patients.
", + ftn, "
", + "Dashed horizontal line represents p-value of 0.05
", + "Dotted horizontal line represents FDR adjsuted p-value of approximately 0.05" + ) + + } + + return(HTML(ft)) + }) + + + + + +} + + diff --git a/ui.R b/ui.R index 2dde808..ae0852d 100644 --- a/ui.R +++ b/ui.R @@ -1,59 +1,60 @@ -################################################################################ -# ui.R -# This R Script only defines the Web layout for the Shiny App. -################################################################################ - -ui <- pageWithSidebar( - headerPanel('Volcano Plot'), - sidebarPanel(width = 3, - useShinyjs(), - div(uiOutput("update_UI"), style = "display: inline-block"), - div(style = "display: inline-block; width: 30px"), - div(uiOutput("obtain_UI"), style = "display: inline-block"), - div(style = "display: inline-block; width: 30px"), - div(uiOutput("reset_UI"), style = "display: inline-block"), - br(), - br(), - fileInput("file_ae_test", label = h5("Import SDTM dataset"), accept = ".csv"), - br(), - fileInput("file_statistics", label = h5("Import ADaM dataset"), accept = ".csv"), - br(), - uiOutput("summary_by_UI"), - br(), - uiOutput("review_by_UI"), - uiOutput("review_by_please_specify_UI"), - br(), - uiOutput("period_UI"), - uiOutput("period_please_specify_UI"), - br(), - uiOutput("ser_UI"), - uiOutput("drug_UI"), - br(), - uiOutput("test_UI"), - br(), - uiOutput("treatment1_UI"), - br(), - uiOutput("treatment2_UI"), - br(), - uiOutput("treatment1_label_UI"), - br(), - uiOutput("treatment2_label_UI"), - br(), - uiOutput("subgroup_var_UI"), - uiOutput("subgroup_vals_title_UI"), - uiOutput("subgroup_vals_UI"), - uiOutput("X_ref_UI"), - uiOutput("Y_ref_UI"), - uiOutput("pvalue_option_UI") - ), - mainPanel( - uiOutput("volcano_plot_UI"), - br(), - div(uiOutput("footnote_UI"), - style = "font-size: 12px; white-space: pre"), - br(), - uiOutput("volcano_plot_drill_UI") - ) -) - - +################################################################################ +# ui.R +# This R Script only defines the Web layout for the Shiny App. +################################################################################ +# test# +ui <- fluidPage( + tags$head(tags$style(HTML("hr {border-top: 1px solid #999999;}"))), # horizontal line option + fluidRow(align="center",h1("Volcano Plot")), + useShinyjs(), + column(width=4, + wellPanel( + fluidRow( + column(width=1), + column(width=4,radioGroupButtons("data_type","Type: (Doesn't work yet)",choices=c("SDTM","ADaM"), selected="SDTM", status="primary", size="normal")), + column(width=6,fileInput("file_ae_test", label = "Import dataset (.csv)", accept = ".csv")) + )), + conditionalPanel(condition = "output.fileUploaded", + wellPanel( + fluidRow(align="center", + fluidRow( + column(width=4,uiOutput("obtain_UI")), + column(width=4,uiOutput("update_UI")), + column(width=4,uiOutput("reset_UI")) + ), hr(), + fluidRow( + column(width=6,selectInput("summary_by", "Summary By", choices = c("Patients", "Events"), width="75%")), + column(width=6,selectInput("review_by", "Review By", choices = c("PT", "SOC", "Other"), width="75%"), uiOutput("review_by_please_specify_UI")), + ), + fluidRow( + column(width=6,selectInput("period", "Period",choices = c("Treatment emergent", "AE during entire study", "Other"), width="75%"), uiOutput("period_please_specify_UI")), + column(width=6,selectInput("ae_filter", "Adverse Event filter(s)", choices=c("Serious","Drug-related","Mild","Moderate","Severe"), selected=NULL, multiple=TRUE, width="75%") + ),hr(), + fluidRow( + column(width=6,uiOutput("treatment1_UI"), uiOutput("treatment1_label_UI")), + column(width=6,uiOutput("treatment2_UI"), uiOutput("treatment2_label_UI")) + ),hr(), + fluidRow( + selectInput("test", "Measure of Association", choices = c("Rate Ratio", "Risk Ratio", "Hazard Ratio", "Risk Difference", "Rate Difference"), width="75%"), + selectInput("subgroup_var", "Subgroup Variable", choices = c("No Subgroup Variable", "SITE", "SEX", "RACE"),selected = "No Subgroup Variable", width="75%"), uiOutput("subgroup_vals_UI") + ),br(),hr(), + fluidRow( + column(width=6,numericInput("X_ref", "X-axis Reference Lines", value = 0,width="75%") ), + column(width=6,selectInput("pvalue_label", "P-value Transformation",choices = c("None", "-log10"), selected="-log10",width="75%")) + + ) + )) + ) + )), + column(width=8, + uiOutput("volcano_plot_UI"), + + br(), + div(htmlOutput("footnote_UI"),style = "font-size: 12px; white-space: pre"), + htmlOutput("test"), + br(), + DT::dataTableOutput("volcano_plot_drill") + ) +) + + diff --git a/volcano-plot.Rproj b/volcano-plot.Rproj new file mode 100644 index 0000000..066341e --- /dev/null +++ b/volcano-plot.Rproj @@ -0,0 +1,13 @@ +Version: 1.0 + +RestoreWorkspace: Default +SaveWorkspace: Default +AlwaysSaveHistory: Default + +EnableCodeIndexing: Yes +UseSpacesForTab: Yes +NumSpacesForTab: 4 +Encoding: UTF-8 + +RnwWeave: Sweave +LaTeX: pdfLaTeX diff --git a/volcano_plot.R b/volcano_plot.R index dd996bb..2c8d880 100644 --- a/volcano_plot.R +++ b/volcano_plot.R @@ -1,187 +1,184 @@ -################################################################################ -# volcano_plot.R -# 1 Function: Generation of volcano plot along with specifications. -################################################################################ - -volcano.plot <- function(data, - statistics_data, - statistics_soc_data, - ser, - drug, - period, - residual, - test, - Treatment1, - Treatment2, - treatment1_label, - treatment2_label, - subgroup_var, - subgroup_vals, - X_ref, - Y_ref, - X_label, - review_by, - summary_by, - pvalue_option) -{ - assign("data", data, envir = .GlobalEnv) - assign("statistics_data", statistics_data, envir = .GlobalEnv) - assign("statistics_soc_data", statistics_soc_data, envir = .GlobalEnv) - assign("ser", ser, envir = .GlobalEnv) - assign("drug", drug, envir = .GlobalEnv) - assign("period", period, envir = .GlobalEnv) - assign("residual", residual, envir = .GlobalEnv) - assign("test", test, envir = .GlobalEnv) - assign("Treatment1", Treatment1, envir = .GlobalEnv) - assign("Treatment2", Treatment2, envir = .GlobalEnv) - assign("treatment1_label", treatment1_label, envir = .GlobalEnv) - assign("treatment2_label", treatment2_label, envir = .GlobalEnv) - assign("subgroup_var", subgroup_var, envir = .GlobalEnv) - assign("subgroup_vals", subgroup_vals, envir = .GlobalEnv) - assign("X_ref", X_ref, envir = .GlobalEnv) - assign("Y_ref", Y_ref, envir = .GlobalEnv) - assign("X_label", X_label, envir = .GlobalEnv) - assign("review_by", review_by, envir = .GlobalEnv) - assign("summary_by", summary_by, envir = .GlobalEnv) - assign("pvalue_option", pvalue_option, envir = .GlobalEnv) - - ### Data pre-processing & data imputation ------------------------------------ - data <- data %>% - mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", - "AGE", "RFENDY", "SAFFN"))], - ~as.character(.)) %>% - mutate_at(names(data), ~na_if(., "")) %>% - mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% - mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) - - - ### Filtering based on selected treatment groups ----------------------------- - data <- data %>% - filter(ARMCD %in% c(Treatment1, Treatment2)) - - - ### Filtering based on subgroup variable ------------------------------------- - if (subgroup_var != "No Subgroup Variable") { - data <- filter(data, length(subgroup_vals) == 0 | get(subgroup_var) %in% subgroup_vals) - } - - - ### Filtering based on other options from control panel ---------------------- - if (ser == TRUE) { - data <- data %>% filter(AESER == "Y") - } - - if (drug == TRUE) { - data <- data %>% filter(AEREL == "Y") - } - - if (period == "Treatment emergent") { - data <- data %>% filter(TRTEMFL == "Y") - } - - if (period == "AE during entire study") { - data <- data %>% filter(STUDYFL == "Y") - } - - if (period == "Other") { - data <- data %>% filter((as.Date(AESTDT) > as.Date(RFSTDTC)) & (as.Date(AESTDT) < (as.Date(RFENDTC) + residual))) - } - - - ### Calculation of lowercase n ----------------------------------------------- - TRT_N <- data %>% - filter(!is.na(AEDECOD)) %>% - group_by(ARMCD) %>% - {if (summary_by == "Patients") filter(., !is.na(RFSTDTC)) else .} %>% - {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% - {if (summary_by == "Events") summarise(., N = n()) else .} - - N1 <- sum(subset(TRT_N, ARMCD %in% Treatment1)$N) - N2 <- sum(subset(TRT_N, ARMCD %in% Treatment2)$N) - - - ### Data preparation for the next step of data integration ------------------- - PT_N <- data %>% - filter(!is.na(AEDECOD) & !is.na(RFSTDTC)) %>% - group_by(AEDECOD, ARMCD) %>% - {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% - {if (summary_by == "Events") summarise(., N = n()) else .} - - SOC_N <- data %>% - filter(!is.na(AEDECOD) & !is.na(RFSTDTC)) %>% - group_by(AEBODSYS, ARMCD) %>% - {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% - {if (summary_by == "Events") summarise(., N = n()) else .} - - - ### Integration of data for the purpose of graph & listing presentation ------ - if (review_by == "SOC") { - statistics_data <- statistics_soc_data %>% - inner_join(data %>% select(ARMCD, AEBODSYS) %>% unique()) %>% - inner_join(SOC_N) %>% - mutate(N1 = (ARMCD %in% Treatment1) * N, - N2 = (ARMCD %in% Treatment2) * N, - pvalue = TESTP, - Summary = paste0("\nSOC:", AEBODSYS, - "\n<", N1, ",", N2,">", - "\n", test, ":", TEST, - "\np-Value:", pvalue)) - } else { - statistics_data <- statistics_data %>% - inner_join(data %>% select(ARMCD, AEBODSYS, AEDECOD) %>% unique()) %>% - inner_join(PT_N) %>% - mutate(N1 = (ARMCD %in% Treatment1) * N, - N2 = (ARMCD %in% Treatment2) * N, - pvalue = TESTP, - Summary = paste0("\nSOC:", AEBODSYS, - "\nPT:", AEDECOD, " <", N1, ",", N2, ">", - "\n", test, ":", TEST, - "\np-Value:", pvalue)) - } - - - ### Construction of volcano plot --------------------------------------------- - if (dim(statistics_data)[1] == 0) { - p <- ggplot() + - annotate("text", x = 4, y = 25, size = 8, label = "No data selected for plot.") + - theme_bw() + - theme(panel.grid.major = element_blank(), - panel.grid.minor = element_blank(), - axis.title.x = element_blank(), - axis.text.x = element_blank(), - axis.ticks.x = element_blank(), - axis.title.y = element_blank(), - axis.text.y = element_blank(), - axis.ticks.y = element_blank()) - return(list(plot = p, data = data)) - } - breaks <- c(Y_ref, 0, .00001, .0001, .001, .01, .1, 1) - key <- row.names(statistics_data) - - # pt_size <- statistics_data %>% - # mutate('N3' = N1+N2) %>% - # select('N3') - pt_size <- statistics_data %>% - mutate('N3' = N1 + N2) - - if (test %in% c("Hazard Ratio", "Rate Ratio", "Risk Ratio")) {x_L <- 0; x_U <- 2 * X_ref} - if (test == "Rate Difference") { - x_L <- min(statistics_data$TEST, na.rm = TRUE) - 1 - x_U <- max(statistics_data$TEST, na.rm = TRUE) + 1 - } - if (test == "Risk Difference") {x_L <- X_ref - 1; x_U <- X_ref + 1} - - p <- ggplot(statistics_data, aes(TEST, pvalue, label = Summary, color = AEBODSYS, key = key)) + - # geom_point() + - geom_point(size = pt_size$N3) + - geom_hline(aes(yintercept = Y_ref), color = 'grey30', linetype = "dotted") + - geom_vline(aes(xintercept = X_ref), color = 'grey30', linetype = "dotted") + - theme_bw() + - xlim(x_L, x_U) + - xlab(X_label) + - scale_y_continuous(trans = reverselog_trans(10), breaks = breaks, labels = fmt_dcimals()) + - coord_cartesian(ylim = c(0.00001, 1)) - return(list(plot = p, data = data, N1 = N1, N2 = N2)) -} - - +################################################################################ +# volcano_plot.R +# 1 Function: Generation of volcano plot along with specifications. +################################################################################ + +volcano.plot <- function(data, + statistics_data, + statistics_soc_data, + ae_filter, + period, + residual, + test, + treatment1, + treatment2, + subgroup_var, + subgroup_vals, + X_ref, + X_label, + review_by, + summary_by, + pvalue_label + ) +{ + + + + ### Data pre-processing & data imputation ------------------------------------ + data <- data %>% + mutate_at(names(data)[!(names(data) %in% c("AESEQ", "AESTDY", "AEENDY", + "AGE", "RFENDY", "SAFFN"))], + ~as.character(.)) %>% + mutate_at(names(data), ~na_if(., "")) %>% + mutate(AEDECOD = ifelse(!is.na(AESTDT) & is.na(AEDECOD), "Not yet coded", AEDECOD)) %>% + mutate(AESTDT = ifelse(is.na(AESTDT) & !is.na(AEDECOD), RFSTDTC, AESTDT)) + + + ### Filtering based on selected treatment groups ----------------------------- + data <- data %>% filter(ARMCD %in% c(treatment1, treatment2)) + + + ### Filtering based on subgroup variable ------------------------------------- + if (subgroup_var != "No Subgroup Variable") { + data <- filter(data, length(subgroup_vals) == 0 | get(subgroup_var) %in% subgroup_vals) + } + + + ### Filtering based on other options from control panel ---------------------- + # filter data for seriousness, drug-related, and severity + if (length(ae_filter)>0){ + if ("Serious" %in% ae_filter) { data <- data %>% filter(AESER == "Y") } + if ("Drug-related" %in% ae_filter) { data <- data %>% filter(AEREL == "Y") } + if (sum(c("Mild","Moderate","Severe") %in% ae_filter)>0){ + severity_filter = ae_filter[which(ae_filter%in% c("Mild","Moderate","Severe"))] + data = data %>% filter(AESEV %in% severity_filter) + } + } + + # filter data for ae timeframe + if (period == "Treatment emergent") { + data <- data %>% filter(TRTEMFL == "Y") + } else if (period == "AE during entire study") { data <- data %>% filter(STUDYFL == "Y") + } else if (period == "Other") { data <- data %>% filter((AESTDT > RFSTDTC) & (AESTDT < (RFENDTC + residual))) + } + + # filter data for seriousness, drug-related, and severity + if (length(ae_filter)>0){ + if ("Serious" %in% ae_filter) { data <- data %>% filter(AESER == "Y") } + if ("Drug-related" %in% ae_filter) { data <- data %>% filter(AEREL == "Y") } + if (sum(c("Mild","Moderate","Severe") %in% ae_filter)>0){ + severity_filter = ae_filter[which(ae_filter%in% c("Mild","Moderate","Severe"))] + data = data %>% filter(AESEV %in% severity_filter) + } + } + + ### Calculation of lowercase n ----------------------------------------------- + TRT_N <- data %>% + filter(!is.na(AEDECOD)) %>% + group_by(ARMCD) %>% + {if (summary_by == "Patients") filter(., !is.na(RFSTDTC)) else .} %>% + {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% + {if (summary_by == "Events") summarise(., N = n()) else .} + + N1 <- sum(subset(TRT_N, ARMCD %in% treatment1)$N) + N2 <- sum(subset(TRT_N, ARMCD %in% treatment2)$N) + + + ### Data preparation for the next step of data integration ------------------- + PT_N <- data %>% + filter(!is.na(AEDECOD) & !is.na(RFSTDTC)) %>% + group_by(AEDECOD, ARMCD) %>% + {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% + {if (summary_by == "Events") summarise(., N = n()) else .} + + SOC_N <- data %>% + filter(!is.na(AEDECOD) & !is.na(RFSTDTC)) %>% + group_by(AEBODSYS, ARMCD) %>% + {if (summary_by == "Patients") summarise(., N = length(unique((USUBJID)))) else .} %>% + {if (summary_by == "Events") summarise(., N = n()) else .} + + + ### Integration of data for the purpose of graph & listing presentation ------ + if (review_by == "SOC") { + statistics_data <- statistics_soc_data %>% group_by() %>% + inner_join(data %>% select(ARMCD, AEBODSYS) %>% unique()) %>% + inner_join(SOC_N) %>% + mutate(N1 = (ARMCD %in% Treatment1) * N, + N2 = (ARMCD %in% Treatment2) * N, + pvalue = TESTP, + adjpvalue = p.adjust(pvalue, method="fdr"), + Summary = paste0("\nSOC:", AEBODSYS, + "\n","n=",ifelse(N1==0,N2,N1), + "\n", test, ":", TEST, + "\np-Value:", round(pvalue,4))) + } else { + statistics_data <- statistics_data %>% group_by() %>% + inner_join(data %>% select(ARMCD, AEBODSYS, AEDECOD) %>% unique()) %>% + inner_join(PT_N) %>% + mutate(N1 = (ARMCD %in% treatment1) * N, + N2 = (ARMCD %in% treatment2) * N, + pvalue = TESTP, + adjpvalue = p.adjust(pvalue, method="fdr"), + Summary = paste0("\n SOC:", AEBODSYS, + "\n PT:", AEDECOD, + "\n n=",ifelse(N1==0,N2,N1), + "\n", test, ":", TEST, + "\n p-value:", round(pvalue,4)," (adj. p-value: ", round(adjpvalue,4))) + } + + + ### Construction of volcano plot --------------------------------------------- + if (nrow(statistics_data) == 0) { + p <- ggplot() + + annotate("text", x = 4, y = 25, size = 8, label = "No data selected for plot.") + + theme_bw() + + theme(panel.grid.major = element_blank(), + panel.grid.minor = element_blank(), + axis.title.x = element_blank(), + axis.text.x = element_blank(), + axis.ticks.x = element_blank(), + axis.title.y = element_blank(), + axis.text.y = element_blank(), + axis.ticks.y = element_blank()) + return(list(plot = p, data = data)) + } + + + statistics_data = statistics_data %>% filter(TEST!=Inf) + + key <- row.names(statistics_data) + + pvalue_adj0.05 = (statistics_data %>% group_by() %>% filter(adjpvalue<=0.05) %>% arrange(desc(adjpvalue)) %>% slice(1))$pvalue + + + p <- ggplot(statistics_data, aes(TEST, pvalue, label = Summary, key = key)) + + geom_point(aes(size=N), pch=21, alpha=0.5, fill="skyblue2") + + geom_hline(yintercept = 0.05, color = 'grey30', linetype = "dashed") + + geom_hline(yintercept = pvalue_adj0.05, color = 'grey30', linetype = "dotted") + + geom_vline(xintercept = ifelse(grepl("Ratio",test),1,0), color = 'grey30', linetype = "dashed") + + geom_vline(xintercept = ifelse(grepl("Ratio",test),1,0)+c(-X_ref,X_ref), color = 'grey30', linetype = "dashed") + + theme_classic() + + background_grid(major = "xy", minor = "none", color.major="grey92")+ + theme(legend.position = "none")+ + scale_x_continuous(X_label,expand = expansion(mult = c(0.05, 0.05)))+ + scale_size_continuous(range = c(2, 15)) + + if (pvalue_label=="-log10"){ + p=p+ scale_y_continuous("-log10(p-value)", + trans = reverselog_trans(10), + breaks = as.numeric(paste0("1e-",0:20)), + labels = as.character(0:20), + expand = expansion(mult = c(0.05, 0.05))) + } else if (pvalue_label=="None"){ + p=p+ scale_y_continuous("P-value", + trans = reverselog_trans(10), + breaks = c(0.05, 0, .000000001,.00000001,.0000001,.000001,.00001,.00001, .0001, .001, .01, .1, 1), + labels = as.character(c(0.05, 0, .000000001,.00000001,.0000001,.000001,.00001,.00001, .0001, .001, .01, .1, 1)), + expand = expansion(mult = c(0.05, 0.05))) + + } + + return(list(plot = p, data = data, N1 = N1, N2 = N2)) +} + +