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Some variables have been added to sections as noted below. Both of these are restricted in use, as noted in the Usage Restrictions column.  Many variable labels, notes, definitions, or examples were revised. In most cases, these revisions were to use the phrase 'treatment or product' for the case when product use is not considered a treatment. The type of revisions made are described in the tables below:

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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keySDTM-711






Revisions made

Variable

Section

New

Modified

Removed

Label

Notes

Definition

Examples

--TRT

Section 3.1.1 The Interventions Observation Class


X


X

X

X


--RSDISC

Section 3.1.1 The Interventions Observation Class


X


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

X

GNTXAID


Section 3.1.4 Identifiers for All Classes

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

Section 3.2.1 Demographics

X







RFENDTC

Section 3.2.1 Demographics

X







RFSTDTC

Section 3.2.1 Demographics

X







RFXENDTC

Section 3.2.1 Demographics

X







RFXSTDTC

Section 3.2.1 Demographics

X








The following textual changes have been made:

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