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Variable Name	Variable Label	Type
STUDYID	Study Identifier	text
USUBJID	Unique Subject Identifier	text
SITEID	Study Site Identifier	text
ASTDT	Analysis Start Date	integer
ASTDTM	Analysis Start Date/Time	integer
AENDT	Analysis End Date	integer
AENDTM	Analysis End Date/Time	integer
ASTDY	Analysis Start Relative Day	integer
AENDY	Analysis End Relative Day	integer
APERIOD	Period	integer
APERIODC	Period (C)	text
APHASE	Phase	text
TRTEMFL	Treatment Emergent Analysis Flag	text
AETRTEM	Treatment Emergent Flag	text
AOCCFL	1st Occurrence within Subject Flag	text
AOCCPFL	1st Occurrence of Preferred Term Flag	text
AOCCSFL	1st Occurrence of SOC Flag	text
AESER	Serious Event	text
AEREL	Causality	text
RELGR1	Pooled Causality Group 1	text
RELGR1N	Pooled Causality Group 1 (N)	integer
AETOXGR	Standard Toxicity Grade	text
ATOXGR	Analysis Toxicity Grade	text
ATOXGRN	Analysis Toxicity Grade (N)	integer
TRTP	Planned Treatment	text
COUNTRY	Country	text
AGE	Age	integer
SEX	Sex	text
RACE	Race	text
ETHNIC	Ethnicity	text
SAFFL	Safety Population Flag	text
RANDFL	Randomized Population Flag	text
TRTSDT	Date of First Exposure to Treatment	integer
TRTEDT	Date of Last Exposure to Treatment	integer
AETERM	Reported Term for the Adverse Event	text
AEBODSYS	Body System or Organ Class	text
AEDECOD	Dictionary-Derived Term	text
AEOUT	Outcome of Adverse Event	text
AESEQ	Sequence Number	integer

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