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Comment: added sections 5.1.2 and 5.1.6 to GNTXAID per SDTM-771

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VARIABLES

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Modifications made to existing Variable

Variable

Section

New Variable

Label

Notes

Definition

Usage Restrictions?

Examples

--TRT

Section 3.1.1, The Interventions Observation Class


X

X

X



--RSDISC

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Section 3.1.1, The Interventions Observation Class


X

X

X



--DOSFRM

Section 3.1.1, The Interventions Observation Class




X



--DOSFRQ

Section 3.1.1, The Interventions Observation Class




X



--DOSTOT

Section 3.1.1, The Interventions Observation Class




X



--DOSRGM

Section 3.1.1, The Interventions Observation Class




X



--ACN

Section 3.1.2, The Events Observation Class


X


X



--ACNOTH

Section 3.1.2, The Events Observation Class




X



--REL

Section 3.1.2, The Events Observation Class




X



--SPEC

Section 3.1.3, The Findings Observation Class




X


X

--CELLEV

Section 3.1.3, The Findings Observation Class

X






GNTXAID

Section 3.1.4, Identifiers for All Classes

Section 5.1.2, Trial Sets

Section 5.1.6, Trial Summary Information

X






SPTOBID

Section 3.1.4, Identifiers for All Classes

X






STOCONID

Section 3.1.4, Identifiers for All Classes

X






--XDY

Section 3.1.5, Timing Variables for All Classes




X

--XENDY

Section 3.1.5, Timing Variables for All Classes




X

--XSTDY

Section 3.1.5, Timing Variables for All Classes




X

ACTARMUD

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Section 3.2.1, Demographics



XX

RFENDTC

Section 3.2.1, Demographics



X


RFSTDTC

Section 3.2.1, Demographics



X


RFXENDTC

Section 3.2.1, Demographics


X
X

RFXSTDTC

Section 3.2.1, Demographics


X
X

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