Sample Report Revision History

Sample Report Revision History

September 20th, 2016 CURRENT VERSION

  • Updated SDAC contact information in Introduction
  • Added Figure DEMOCOL-1 (example of color display)

October 15, 2014

  • 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

December 4, 2013

Removed “CONFIDENTIAL” watermark from each page as this is intended to be a freely circulated document

April 30, 2013

Removed Roman numbering from Introduction; all pages are now sequentially ordered beginning with page 1

 April 26, 2013

  • Figure ACCR–5: “Country Participation”  – Fixed a bug in SAS code causing incorrect means for region totals

November 6, 2012

  • Figure ENDPT–2: “Hazard Ratios: All-Cause Mortality”  – Added interaction p-values.

September 1, 2011

  • 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