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Tobacco Implementation Guide (TIG) v1.0
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Tobacco Implementation Guide Home
TIG examples
TIG Product Impact on Individual Health examples
ADaM Example.ADEX Exposure
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Versions Compared
Old Version
28
changes.mady.by.user
Christine Connolly
Saved on
Oct 03, 2023
compared with
New Version
29
changes.mady.by.user
Christine Connolly
Saved on
Oct 03, 2023
Previous Change: Difference between versions 27 and 28
Next Change: Difference between versions 29 and 30
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Definexmltable
Level
Dataset
Purpose
Analysis
Name
ADEXSUM
Dataset
Description
Class
Structure
Purpose
Keys
Location
Documentation
ADEXSUM
Exposure Summary Analysis Dataset
BASIC DATA STRUCTURE
One or more records per subject per analysis parameter
Analysis
STUDYID, USUBJID, PARAM
ADEXSUM.xpt
ADEXSUM.SAS/SAP
Definexmltable
Dataset
ADEXSUM
Level
Variable
Purpose
Analysis
Name
ADEXSUM
Variable Name
Variable Label
Type
Codelist/Controlled Terms
Core
CDISC Notes
STUDYID
Study Identifier
Char
Req
ADEX.STUDYID
USUBJID
Unique Subject Identifier
Char
Req
ADEX.USUBJID
TRTA
Actual Product
Char
Cond
ADEX.TRT01A
PARAM
Parameter
Char
Req
Assigned
PARAMCD
Parameter Code
text
Req
Assigned
PARAMN
Parameter (N)
Num
Perm
Assigned
AVAL
Analysis Value
Num
Cond
see parameter level metadata
SAFFL
Safety Population Flag
Char
Y;N
Cond
ADSL.SAFFL
Overview
Content Tools
{"serverDuration": 88, "requestCorrelationId": "7da1745004dea9ef"}