Characteristic | RCTs before 2012 (1974–2012) | RCTs after 2012 (2013–2017) | Total RCTs | |||
---|---|---|---|---|---|---|
 | No. of studies, n (%) | No. of patients, n (%) | No. of studies, n (%) | No. of patients, n (%) | No. of studies, n (%) | No. of patients, n (%) |
 | 18 (100.0) | 4058 (100.0) | 9 (100.0) | 2098 (100.0) | 27 (100.0) | 6156 (100.0) |
Trial phasea | ||||||
 III | 7 (38.9) | 2061 (50.8) | 4 (44.4) | 1473 (70.2) | 11 (40.7) | 3534 (57.4) |
 II | 5 (27.8) | 512 (12.6) | 5 (55.6) | 625 (29.8) | 10 (37.0) | 1137 (18.5) |
 NS | 6 (33.3) | 1485 (36.6) | 0 (0.0) | 0 (0.0) | 6 (22.2) | 1485 (24.1) |
Primary endpoint | ||||||
 OS | 0 (0.0) | 0 (0.0) | 2 (22.2) | 1095 (52.2) | 2 (7.4) | 1095 (17.8) |
 PFS | 3 (16.7) | 586 (14.4) | 5 (55.6) | 628 (29.9) | 8 (29.6) | 1214 (19.7) |
 Other time-to-event | 0 (0.0) | 0 (0.0) | 2 (22.2) | 375 (17.9) | 2 (7.4) | 375 (6.1) |
 RR | 1 (5.6) | 95 (2.3) | 0 (0.0) | 0 (0.0) | 1 (3.7) | 95 (1.5) |
 NS | 14 (77.8) | 3377 (83.2) | 0 (0.0) | 0 (0.0) | 14 (51.9) | 3377 (54.9) |
ITT analysis included | ||||||
 No | 17 (94.4) | 3963 (97.7) | 1 (11.1) | 118 (5.6) | 18 (66.7) | 4081 (66.3) |
 Yes | 1 (5.6) | 95 (2.3) | 8 (88.9) | 1980 (94.4) | 9 (33.3) | 2075 (33.7) |
Post-protocol treatment described | ||||||
 No | 10 (55.6) | 2885 (71.1) | 3 (33.3) | 374 (17.8) | 13 (48.1) | 3259 (52.9) |
 Yes | 8 (44.4) | 1173 (28.9) | 6 (66.7) | 1724 (82.2) | 14 (51.9) | 2897 (47.1) |