ae CRFs

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Example Case Report Forms for AE domain

Form: Adverse Events

Question	Response
Adverse Event Verbatim	AETERM, FA.FAOBJ
Event Category	General Adverse Event Event of Interest AECAT
Did the event start before administering first dose of study medication?	Yes No PRFDOS in SUPPAE
Date Started	AESTDTC
Event ongoing?	No Yes AEENRTPT=ONGOING AEENTPT=END OF STUDY
Date Ended	AEENDTC
Severity of the Event	Mild Moderate Severe AESEV
Event Related to Study Drug	Yes No AEREL
Toxicity Grade of the Event (CTCAE)	1 2 3 4 5 AETOXGR
Action Taken with Study Drug because of Adverse Event	No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn AEACN
Other action taken?	AEACNOTH
Serious Event?	Yes No AESER
Resulted in Death?	Yes No AESDTH
Immediately Life Threatening?	Yes No AESLIFE
Required Hospitalization or Prolonged Hospitalization?	Yes No AESHOSP
If hospitalized,�
date of hospitalization	HOSTDTC
Time of hospitalization	HOSTDTC
If hospitalized,�
date of discharge	HOENDTC
Time of discharge	HOENDTC
Persistent or Significant Disability?	Yes No AESDISAB
Congenital Anomaly/Birth Defect?	Yes No AESCONG
Other Medically Important Serious Event?	Yes No AESMIE
Outcome of the Event?	Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown AEOUT
Was the event adjudicated	Yes No FAORRES when FATESTCD=ADJUD
Adjudication Result	Positive Negative FAORRES when FATESTCD=ADJRES
Relationship to Non-Study Treatment	Adjunct Therapy Study Disease Other Medical Condition Study Procedure None AERELNST