Date | Version | Summary of Changes |
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2021-09-22 | 2.0 Draft | - Variable QNAM=EVLINTTX replaced by QSEVINTX = LIFETIME.
- QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
- Added QSLOBXFL variable to the example to represent a baseline response for visit 1.
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2014-09-03 | 1.2 | - Updated references to QSCAT and questionnaire name throughout the document.
- Section 3.1: Assumption # 2 – Evaluation Interval mapped to QSEVINTX (from EVLINTTX).
- Section 3.2: Updated text above example table. Example table updated to include QSEVINTX in the QS table. Removed the SUPPQS.xpt table.
- Section 4: (SDTM Mapping Strategy) for QSTESTCD=CSS0111
Old value: Completely to end or stop pain New value: Completely to end or stop the pain |
2013-02-06 | 1.1 | - QSSCAT added to be compatible with all CSSR-S questionnaires
- QSTPT replaced with QNAM=EVLINTTX to be compatible with all CSSR-S questionnaires using evaluation intervals
- Corrected “Dose not apply”, associated with the Most Severe Ideation, Reasons on page 9 to “Does not apply”.
- Added QS terminology reference
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2012-08-07 | 1.0 Final | Initial Version |