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Table 1 Efficacy outcomes

From: A phase 3 study of rituximab biosimilar HLX01 in patients with diffuse large B-cell lymphoma

 Per-protocol datasetFull analysis dataset
H-CHOP (n = 188)R-CHOP (n = 194)P valueH-CHOP (n = 199)R-CHOP (n = 203)P value
Best overall response rate177 (94·1)180 (92·8)0·608184 (92·5)187 (92·1)0·839
 Complete response88 (46·8)101 (52·1)0·23190 (45·2)104 (51·2)0·190
 Partial response89 (47·3)79 (40·7) 94 (47·2)83 (40·9) 
 Stable disease8 (4·3)13 (6·7) 11 (5·5)15 (7·4) 
 Disease progression2 (1·1)1 (0·5) 2 (1·0)1 (0·5) 
 No evidence of disease1 (0·5)0 2 (1·0)0 
Duration of response
 Patients experiencing events25 (13·8)21 (11·5)0·42426 (13·7)21 (11·1)0·355
 Patients censored156 (86·2)161 (88·5) 164 (86·3)168 (88·9) 
Event-free survival
 Patients experiencing events80 (42·6)67 (34·5)0·12588 (44·2)71 (35·0)0·087
 Patients censored108 (57·4)127 (65·5) 111 (55·8)132 (65·0) 
 1-year event-free survival rate55·4 (47·9, 63·0)64·5 (57·6, 71·4) 53·7 (46·4, 61·0)63·4 (56·6, 70·2) 
Progression-free survival
 Patients experiencing events31 (16·5)29 (14·9)0·53433 (16·6)30 (14·8)0·473
 Patients censored157 (83·5)165 (85·1) 166 (83·4)173 (85·2) 
 1-year progression-free survival rate75·0 (66·5, 83·6)80·1 (73·5, 86·7) 74·1 (65·6, 82·7)79·7 (73·1, 86·3) 
Overall survival
 Patient deaths15 (8·0)13 (6·7)0·66116 (8·0)14 (6·9)0·701
 Patients censored173 (92·0)181 (93·3) 183 (92·0)189 (93·1) 
 1-year overall survival rate91·8 (87·8, 95·8)92·4 (88·3, 96·6) 91·6 (87·6, 95·5)92·1 (88·0, 96·3) 
Disease-free survival
 Patients experiencing events27 (14·4)24 (12·4)0·46228 (14·1)25 (12·3)0·477
 Patients censored161 (85·6)170 (87·6) 171 (85·9)178 (87·7) 
 1-year disease-free survival rate77·4 (68·9, 85·9)83·0 (76·7, 89·3) 76·9 (68·4, 85·4)82·6 (76·2, 88·9) 
  1. Data are n (%) or %, (95% CI). Percentage values may not total 100% because of rounding