Page History
The following new section was added:
- Section 6.8 Related References Dataset
Some Three variables have been added to the following sectionsections as noted below.Both of these are restricted in use, as noted in the Usage Restrictions column.
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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:
| Jira | ||||||||
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Revisions made | ||||||||
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| 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 |
Revisions made
Label
| X | X | |||||
-- |
ACNOTH | Section 3.1.2 The Events Observation Class | X | ||||||
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REL | Section 3.1.2 The Events Observation Class | X | ||||||
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SPEC |
| Section 3.1.3 The Findings Observation Class |
Revisions made
Label
--SPEC
| 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 |
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| 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 |
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| X | ||||||||
RFENDTC | Section 3.2.1 Demographics | X | ||||||
RFSTDTC | Section 3.2.1 Demographics | X | ||||||
RFXENDTC | Section 3.2.1 Demographics | X | ||||||
RFXSTDTC |
The following new section was added:
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Section 3.2.1 Demographics | X |
The following textual changes have been made:
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