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Comment: SDTM-711

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Some variables have been added to sections as noted below.

Many variable labels, notes, definitions, or examples were revisedmodified. In most cases, these revisions modifications 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)
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keySDTM-711




Modifications made


Variable

Section

New

Label

Notes

Definition

Usage Restrictions?

Examples

Removed

--TRT

Section 3.1.1 The Interventions Observation Class


X

X

X




--RSDISC

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

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



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




The following textual changes have been made:

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