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Table 1 RCT characteristics

From: Surrogacy of intermediate endpoints for overall survival in randomized controlled trials of first-line treatment for advanced soft tissue sarcoma in the pre- and post-pazopanib era: a meta-analytic evaluation

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)
  1. aPhase II/III studies were counted as phase III studies
  2. Abbreviations: ITT, intention-to-treat; No., number; NS, not specified; OS, overall survival; PFS, progression-free survival; RCT, randomized controlled trial; RR, response rate