PPT Slide
Three Alternate Approaches Suggested by the FDA
Approach #1
- Patients who died or were transplanted after withdrawal but within 100 days of randomization were reassigned to the deterioration group
- 2 active + 1 placebo patients reclassified to worst rank
Approach #2
- Patients who died or were transplanted after withdrawal but within 100 days of randomization plus patients who received epoprostenol within 30 days of discontinuation were reassigned to the deterioration group
- 8 active + 1 placebo patients reclassified to worst rank
Approach #3
- Patients who died, were transplanted or received epoprostenol after withdrawal but within 100 days of randomization were reassigned to the deterioration group
- 10 active + 1 placebo reclassified to worst rank