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Rowcaps

Rows 1-2:

Show examples of modifying the reported term for coding purposes, with the modified term in AEMODIFY. These adverse events were not serious, so the seriousness criteria variables are null. Note that for the event in row 2, AESTDY = "1". Day 1 was the day treatment started; the AE start and end times, as well as dates, were collected to allow comparison of the AE timing to the start of treatment.

Row 3:

Shows an example of the overall seriousness question AESER answered with "Y" and the relevant corresponding seriousness category variables (AESHOSP and AESLIFE) answered "Y". The other seriousness category variables are left blank. This row also shows AEENRF being populated because the AE was marked as “Continuing” as of the end of the study reference period for the subject (see Section 4.4.7, Relative Timing Variables).

Dataset2

Row	STUDYID	DOMAIN	USUBJID	AESEQ	AETERM	AEMODIFY	AEDECOD	AEBODSYS	AESEV	AESER	AEACN	AEREL	AEOUT	AESHOSP	AESLIFE	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY	AEENRF
1	ABC123	AE123101	ABC123-0001	1	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	SEVERE	N	NOT APPLICABLE	DEFINITELY NOT RELATED	RECOVERED/RESOLVED			SCREENING	20052004-10-122005	2004-10-1214	-1-1	2
2	ABC123	AE123101	ABC123-0001	2	BACK PAIN FOR 6 HOURS	BACK PAIN	Back pain	Musculoskeletal and connective tissue disorders	MODERATE	N	DOSE REDUCED	PROBABLY RELATED	RECOVERED/RESOLVED			PRODUCT EXPOSURE	20052004-10-13T13:05	20052004-10-13T19:00	1	1
3	ABC123	AE123101	ABC123-0001	3	PULMONARY EMBOLISM		Pulmonary embolism	Vascular disorders	MODERATE	Y	DOSE REDUCED	PROBABLY NOT RELATED	RECOVERING/RESOLVING	Y	Y	PRODUCT EXPOSURE	20052004-10-21		9		AFTER

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