crfgen - JSON CRF Library

Forms in AE (2)

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Adverse Events

Sources: DB1, SDTM | Forms loaded: 2

AE (Adverse Events)

FA (Findings About Events or Interventions)

HO (Healthcare Encounters)

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AE, FA, HO

#	Question	Response / annotation
1	Adverse Event Verbatim field_001	AETERM FAOBJ
2	Event Category field_002	General Adverse Event Event of Interest AECAT
3	Did the event start before administering first dose of study medication? field_003	Yes No PRFDOS in SUPPAE
4	Date Started field_004	AESTDTC
5	Event ongoing? field_005	No Yes AEENRTPT
6	Date Ended field_006	AEENDTC
7	Severity of the Event field_007	Mild Moderate Severe AESEV
8	Event Related to Study Drug field_008	Yes No AEREL
9	Toxicity Grade of the Event (CTCAE) field_009	1 2 3 4 5 AETOXGR
10	Action Taken with Study Drug because of Adverse Event field_010	No action taken Dose increased Dose reduced Drug interrupted Drug withdrawn AEACN
11	Other action taken? field_011	AEACNOTH
12	Serious Event? field_012	Yes No AESER
13	Resulted in Death? field_013	Yes No AESDTH
14	Immediately Life Threatening? field_014	Yes No AESLIFE
15	Required Hospitalization or Prolonged Hospitalization? field_015	Yes No AESHOSP
16	Hospital admission details field_016
17	Date of hospitalization field_017	HOSTDTC
18	Time of hospitalization field_018	HOSTDTC
19	Hospital discharge details field_019
20	Date of discharge field_020	HOENDTC
21	Time of discharge field_021	HOENDTC
22	Persistent or Significant Disability? field_022	Yes No AESDISAB
23	Congenital Anomaly/Birth Defect? field_023	Yes No AESCONG
24	Other Medically Important Serious Event? field_024	Yes No AESMIE
25	Outcome of the Event? field_025	Recovered/Resolved Not Recovered/Not Resolved Fatal Unknown AEOUT
26	Was the event adjudicated? field_026	Yes No FAORRES when FATESTCD = ADJUD
27	Adjudication Result field_027	Positive Negative FAORRES when FATESTCD = ADJRES
28	Relationship to Non-Study Treatment field_028	Adjunct Therapy Study Disease Other Medical Condition Study Procedure None AERELNST

Adverse Event Log

Sources: DB1, SDTM | Forms loaded: 2

AE (Adverse Events)

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#	Question	Response / annotation
1	Subject Identifier PT	USUBJID
2	Adverse Event (verbatim) AETERM_RAW	AETERM
3	MedDRA Preferred Term AEDECOD_RAW	AEDECOD
4	Start Date AESTDT_RAW	AESTDTC
5	End Date AEENDT_RAW	AEENDTC
6	Severity AESEV_RAW	Mild Moderate Severe AESEV
7	Serious? AESER_RAW	Yes No AESER
8	Action Taken AEACN_RAW	Dose Not Changed Dose Reduced Drug Interrupted Drug Withdrawn AEACN
9	Causality AEREL_RAW	Not Related Possibly Related Probably Related Related AEREL
10	Outcome AEOUT_RAW	Recovered/Resolved Recovering Not Recovered Fatal Unknown AEOUT