Sample Report Revision History
September 20th, 2016 CURRENT VERSION
- Updated SDAC contact information in Introduction
- Added Figure DEMOCOL-1 (example of color display)
- Added Figures AELISTING–1, AE–4, BYPTLFT–1, and DTH–1
- Added Figures ENDPT–1, ENDPT–2 (previous figures renamed to ENDPT–3 and ENDPT–4)
- Added Ancillary Material section
- Figures SAE–2, AE–2 – Changed display order to MedDRA internationally agreed order (from alphabetical)
- Figures SAETAB, AETAB – Added high level terms and added results for the “Vascular disorders” system organ class
- Figure LFTABN–1 – Added lower panel
- Figures LFT–1 through LFT–3 – Re-ordered individual tests in these displays
Removed “CONFIDENTIAL” watermark from each page as this is intended to be a freely circulated document
Removed Roman numbering from Introduction; all pages are now sequentially ordered beginning with page 1
- Figure ACCR–5: “Country Participation” – Fixed a bug in SAS code causing incorrect means for region totals
- Figure ENDPT–2: “Hazard Ratios: All-Cause Mortality” – Added interaction p-values.
- Figure ENDPT–1: “All-Cause Mortality” – Added the panels titled “Difference in Cumulative Event Rates” and “Difference in Log(Cumulative Hazard)”.
June 1, 2010 First version posted to website