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Table 1 Trial Outcome Measures

From: Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial

Trials stage Primary outcome measures Secondary outcome measures
Pilot phase Safety* Feasibility
Activity Stage I I: Failure-free survival (FFS) Overall survival (OS)
   Toxicity
   Skeletal related events
Activity Stage II I: Failure-free survival (FFS) Overall survival (OS)
   Toxicity
   Skeletal related events
Activity Stage III I: Failure-free survival (FFS) Overall survival (OS)
   Toxicity
   Skeletal related events
Efficacy Stage IV D: Overall survival Quality of life
   Cost effectiveness
   Failure-free survival
   Toxicity
   Skeletal related events
  1. *Based on toxicity
  2. Including biochemical failure (see protocol)