Table 2

Model of number of patients meeting the inclusion criteria required to meet target event rate decreases

StrategyProportion of patients with predictive probability of experiencing a PFS event at year 1 on placebo in RAINIER (%)Observed proportion of patients with PFS events at year 1 in the risk group in RAINIER (%)Number of patients eligible for RAINIER required at screening to identify one patient in the risk group, nNumber of patients in risk group needed to identify 1 PFS event in that risk group, nTotal number of RAINIER-eligible patients needed to reach target event rate (247 events in risk group), n
RAINIER overall47.847.1517
Model-predicted probability threshold, percentile
 >10%93.249.31.072.03538
 >20%80.455.31.241.81556
 >30%67.761.01.481.64599
 >40%53.766.41.861.51693
 >50%42.273.62.371.36796
 >60%33.683.02.981.20886
 >70%25.588.13.921.141100
 >80%17.687.75.681.141601
  • PFS, progression-free survival.