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Dataset wrap

Name	adae

Dataset2

tableid	adae

Row	STUDYID	USUBJID	AETERM	AEMODIFY	AEDECOD	AEBODSYS	ASTDT	AENDT	ASTDY	AENDY	PREFL	TRTEMFL	FUPFL	AETRTEM	AOCCFL	AOCCPFL	AOCCSFL	AESER	AEREL	AERLDEV	RELGR1	AESEV	AEACN	AEACNDEV	AEOUT	TRTA	SAFFL	TRTSDT	TRTEDT	AESEQ	AESTDTC	AEENDTC	AESTDY	AEENDY	AEENRF
1	A123	A2001	POUNDING HEADACHE	HEADACHE	Headache	Nervous system disorders	21JAN2021	21JAN2021	14	14		Y						N	DEFINITELY NOT RELATED		NOT RELATED	SEVERE	DOSE NOT CHANGED		RECOVERED/RESOLVED	Placebo	Y	08JAN2021	28JAN2021	1	2021-01-21	2021-01-21	14	14
2	A123	A2008	SKIN REDNESS	SKIN REDNESS	Skin Redness		16FEB2021	21FEB2021	9	14		Y		Y	Y	Y	Y	N	PROBABLY RELATED	RELATED	RELATED	MODERATE	DOSE NOT CHANGED	DEVICE REPLACED	RECOVERED/RESOLVED	Placebo	Y	08FEB2021	01MAR2021	2	2021-02-16	2021-02-21	9	14
3	A123	A3009	INFLUENZA	INFLUENZA	Influenza	Infections and infestations	21JUN2021	26JUN2021	13	18		Y	Y	Y		Y	Y	Y	PROBABLY NOT RELATED		NOT RELATED	SEVERE	TRIAL INTERVENTION DISCONTINUED		RECOVERING/RESOLVING	Placebo	Y	09JUN2021	21JUN2021	3	2021-06-21	2021-06-26	13	18

Definexmltable

Level	Dataset
Purpose	Analysis
Name	ADAE

Dataset	Description	Class	Structure	Purpose	Keys	Location	Documentation
ADAE	Adverse Events Analysis Dataset	OCCURRENCE DATA STRUCTURE	One record per subject per adverse event	Analysis	STUDYID, USUBJID,

PARQUAL

AEBODSYS,

PARAMCD, AVISIT,

AEDECOD, AETERM

ADAE.xpt

ADAE

ADSL

.SAS/SAP

Cond

Definexmltable

Dataset	ADAE
Level	Variable
Purpose	Analysis
OID	ADAE
Name	ADAE

Variable Name	Variable Label	Type	Core	Notes
STUDYID	Study Identifier	text	Req	AE.STUDYID
USUBJID	Unique Subject Identifier	text	Req	AE.USUBJID
AETERM	Reported Term for the Adverse

Event

Experience	text		Req	AE.AETERM
AEMODIFY	Modified Reported Term	text		Perm	AE.MODIFY
AEBODSYS	Body System or Organ Class	text		Req	AE.AEBODSYS
AEDECOD	Dictionary-Derived Term	text		Req	AE.AEDECOD
ASTDT	Analysis Start Date	integer		Cond	Created from converting AE.AESTDTC from character ISO8601 format to numeric date format
AENDT	Analysis End Date	integer		Cond	Created from converting AE.AEENDTC from character ISO8601 format to numeric date format
ASTDY	Analysis Start Relative Day	integer		Cond	ASTDT – ADSL.TRTSDT + 1 if ASTDT ≥ TRTSDT, else ASTDT – ADSL.TRTSDT if ASTDT< TRTSDT
AENDY	Analysis End Relative Day	integer		Cond	AENDT – ADSL.TRTSDT + 1 if AENDT ≥ TRTSDT, else AENDT – ADSL.TRTSDT if AENDT < TRTSDT
PREFL	Pre-product Flag	text	Y	Cond	If ASTDT < ADSL.TRTSDT then PREFL=’Y’
TRTEMFL

Productt

Product

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-787

Emergent Analysis Flag

text

Y

Cond

If ADSL.TRTSDT≤ASTDT then TRTEMFL=’Y’

FUPFL

Follow-up Flag

text

Y

Cond

If ASTDT > ADSL.TRTEDT then FUPFL=’Y’

AETRTEM

Product Emergent Flag

text

(NY)

Perm

SUPPAE.QVAL where QNAM=’AETRTEM’.

AOCCFL

1st Occurrence within Subject Flag

text

Y

Perm

Sort the data in the required order and flag the first

treatment

product emergent record for each subject.
AOCCPFL	1st Occurrence of Preferred Term Flag	text	Y	Perm	Sort the data in the required order and flag the first

treatment

product emergent record for each AEDECOD for each subject.
AOCCSFL	1st Occurrence of SOC Flag	text	Y	Perm	Sort the data in the required order and flag the first

treatment

product emergent record for each body system for each subject.
AESER	Serious

Event

Experience

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-788

text

(NY)

Req

AE.AESER

AEREL

Causality

text

Perm

AE.AEREL

AERLDEV

Relationship of Event to Device

text

*

Perm

AE.AERLDEV

RELGR1

Pooled Causality Group y

text

Perm

set to RELATED if AE.AEREL in (DEFINITELY,PROBABLY,POSSIBLY), set to NOT RELATED if AEREL in (PROBABLY NOT, DEFINITELY NOT)

AEACN

Action Taken with Study Product

text

(

ACN

AEOUT	Outcome of Adverse
TPACN)	Perm	AE.AEACN
AEACNDEV	Action Taken with Device	text		Perm	AE.AEACNDEV

Event

Experience	text	(OUT)	Perm	AE.AEOUT

TRTP

Planned Product

text

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