APPENDIX
TRILOGY ACS Endpoint Survey
Allocating Weights to Non-fatal and Fatal Events: The Wheel of
Misfortune
In an effort to allocate relative value to various endpoints of a clinical trial, we ask you to
evaluate the relative severity of the four endpoints and assign scores that weigh their relative
importance to you in deciding on the efficacy of a new therapy. Please ensure that your three
choices add up to a 20 point total.
Event
Points
Death
Stroke
Myocardial Infarction
Total
1.
2.
20
There are three events to consider in terms of efficacy: Death, Stroke, and MI (Please refer
to the definitions on Page 4).
Please allocate all twenty points amongst the three efficacy events based on your opinion
of their relative severity, starting with death. Fill in the table with the number of allocated
points per event. Every event must be assigned at least one point.
Part 2
From: ____________________
Refinement of the Efficacy: Safety Trade-off
1. Please indicate the maximum number of increased bleeding events [i.e. either severe or severe
and life threatening] you would accept to achieve a 20% reduction in MI events i.e. 15 per
1000 patients.
20% relative
reduction of MI’s
Severe/Lifethreatening bleeding
Baseline rate 3%
Severe bleeding
Baseline rate
3%
(30 patients/ 1000)
(30 patients/
1000)
Type of MI
Large
15 per 1000pts
___ per 1000pts
___ per 1000pts
Moderate
15 per 1000pts
___ per 1000pts
___ per 1000pts
Peri-procedural
15 per 1000pts
___ per 1000pts
___ per 1000pts
2.
Please indicate the maximum number of bleeding events you would accept to achieve a 20%
reduction in stroke events.
20% reduction in
stroke
Severe/Lifethreatening bleeding
Severe bleeding
Baseline rate 3%
Baseline rate 3% (30
patients/ 1000)
(30 patients/ 1000)
Type of Stroke
Disabling
3 per 1000pts
___ per 1000pts
___ per 1000pts
Non-disabling
3 per 1000pts
___ per 1000pts
___ per 1000pts
TIA
3 per 1000pts
___ per 1000pts
___ per 1000pts