Activity Stage
|
Timing of analysis: control arm events
|
Critical value
(Hazard Ratio)
|
---|
I
|
114
|
1·00
|
II
|
215
|
0·92
|
III
|
334
|
0·89
|
- The intermediate analyses are timed according to the number of events reports on the control arm. Discontinuation of recruitment to a research arm will be considered if the observed hazard ratio is greater than the critical value (also known as the critical cutpoint or "hurdle")