Page History
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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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Modifications made | ||||||||
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Variable | Section | New |
Modified
Label | Notes | Definition | Usage Restrictions? | Examples | Removed | |
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--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 | ||||||
--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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