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 |