Table 2.

mCMO for the high (A), medium (B), and low (C) required benefit for SMALL: number of trials meeting these criteria for success out of the 43 pivotal randomized studies analyzed according to the selection criteria described in the text

CriteriaNumber of positive trials
Prognosis in control armTrials analyzed (n)HRMedian gain in OSHRMedian gain in OS“Either” parameter“Both” parameters
A. High threshold for mCMO: SMALL
 <9 mo90.603 mo1331
 9–12 mo80.654 mo0110
 12–18 mo90.655 mo1010
 >18 mo170.706 mo2231
B. Medium threshold for mCMO: SMALL
 <9 mo90.652.5 mo1441
 9–12 mo80.703 mo2332
 12–18 mo90.703.5 mo3452
 >18 mo170.754 mo3663
C. Low threshold for mCMO: SMALL
 <9 mo90.702 mo4554
 9–12 mo80.752.5 mo5454
 12–18 mo90.753 mo4563
 >18 mo170.803.5 mo4774