SDTM Example.ADaM Adverse Experiences

ae.xpt

xx.xpt

Row	STUDYID	DOMAIN	SPDEVID	USUBJID	AESEQ	AETERM	AEMODIFY	AEDECOD	AEBODSYS	AESEV	AESER	AEACN	AEACNDEV	AEREL	AERLDEV	AEOUT	AESHOSP	AESLIFE	AECONTRT	EPOCH	AESTDTC	AEENDTC	AESTDY	AEENDY
1	A123	AE		A2001	1	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	SEVERE	N	DOSE NOT CHANGED		DEFINITELY NOT RELATED		RECOVERED/RESOLVED			Y	PRODUCT EXPOSURE	2021-01-21	2021-01-21	16	16
2	A123	AE	VAPE-Z01	A2008	1	SKIN REDNESS	SKIN REDNESS	Skin Redness		MODERATE	N	DOSE NOT CHANGED	DEVICE REPLACED	PROBABLY RELATED	RELATED	RECOVERED/RESOLVED			N	PRODUCT EXPOSURE	2021-02-16	2021-02-21	8	13
3	A123	AE		A3009	1	INFLUENZA	INFLUENZA	Influenza	Infections and infestations	SEVERE	Y	PRODUCT DISCONTINUED		PROBABLY NOT RELATED		RECOVERING/RESOLVING	Y	Y	Y	PRODUCT EXPOSURE	2021-06-21	2021-06-26	13	18

$warningHtml

Page tree