Adverse Event

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Adverse Event

Adverse events may be captured either as free text or a pre-specified list of terms.

Variables Data Type Question Code List Validation
aeyn radio Were any adverse events experienced? ny
aespid text AE Identifier
aeterm text What is the adverse event term?
aeoccur radio Does the subject have [specific adverse event]? ny
aestdtc text What is the date and time the adverse event started? datetime_dmy
aestdat text What is the date the adverse event started? date_dmy
aesttim text At what time did the adverse event start? time
aeongo radio Is the adverse event ongoing? ny
aeendtc text What is the date and time the adverse event end? datetime_dmy
aeendat text What date did the adverse event end? date_dmy
aeentim text At what time did the adverse event end? time
aesev radio What was the severity of the adverse event? aesev
aetoxgr radio What is the toxicity grade of the adverse event? toxgr
aeser radio Is the adverse event serious? ny
saestdtc text What is the date and time the adverse event/ reaction became serious? datetime_dmy
saestdat text What is the date the adverse event/ reaction became serious? date_dmy
saesttim text What is the time the adverse event/ reaction became serious? time
saeongo radio Is the serious adverse event ongoing? ny
saeendtc text What is the end date and time of the serious adverse event/reaction? datetime_dmy
saeendat text What is the end date of the serious adverse event/reaction? date_dmy
saeentim text What is the end time of the serious adverse event/reaction? time
aescong radio Is the adverse event associated with a congenital anomaly or birth defect? ny
aesdisab radio Did the adverse event result in persistent or significant disability or incapacity? ny
aesdth radio Did the adverse event result in death? ny
dsstdat_sdth text What is the date of the subjects death? date_dmy
prcdth text What was the reported primary cause of death?
secdth text What was the reported secondary cause of death?
auperf radio Was an autopsy performed? ny
aucdth notes What was the autopsy determined cause of death?
aeshosp radio Did the adverse event result in initial or prolonged hospitalisation for the subject? ny
aeslife radio Is the adverse event life threatening? ny
aesmie radio Is the adverse event a medically important event not covered by other serious criteria? ny
aerel radio Is this event related to study treatment? ny
aeacn dropdown What action was taken with study treatment? acn autocomplete
aeacnoth notes What other action was taken in response to this adverse event?
aeout dropdown What was the outcome of this adverse event? out autocomplete
aedis radio Did the adverse event cause the subject to be discontinued from the study? ny