Grade 3–4 toxicity | Investigational arm | Control arm | P valuea |
---|---|---|---|
 | (N = 149, %) | (N = 147, %) |  |
Any | 87 (58.4%) | 86 (58.5%) | 0.984 |
Induction phase | |||
 Leucopenia | 36 (24.2) | 27 (18.4) | 0.223 |
 Neutropenia | 61 (40.9) | 45 (30.6) | 0.064 |
 Anaemia | 2 (1.3) | 2 (1.4) | 0.989 |
 Thrombocytopenia | 5 (3.4) | 1 (0.7) | 0.102 |
 Liver function | 3 (2.0) | 2 (1.4) | 0.663 |
 Renal function | 0 (0) | 0 (0) | 1.000 |
 Skin reaction | 23 (15.4) | 3 (2.0) | < 0.001 |
 Mucositis | 15 (10.1) | 5 (3.4) | 0.022 |
 Nausea | 3 (2.0) | 2 (1.4) | 0.663 |
 Vomiting | 8 (5.4) | 12 (8.2) | 0.338 |
 Diarrhoea | 3 (2.0) | 1 (0.7) | 0.321 |
Concurrent phase | |||
 Leucopenia | 31 (20.8) | 40 (27.2) | 0.197 |
 Neutropenia | 19 (12.8) | 24 (16.3) | 0.383 |
 Anaemia | 11 (7.4) | 15 (10.2) | 0.391 |
 Thrombocytopenia | 13 (8.7) | 8 (5.4) | 0.271 |
 Liver function | 3 (2.0) | 5 (3.4) | 0.462 |
 Renal function | 0 (0) | 2 (1.4) | 0.246 |
 Skin reaction | 8 (5.4) | 38 (25.9) | < 0.001 |
 Mucositis | 37 (24.8) | 54 (36.7) | 0.026 |
 Nausea | 14 (9.4) | 18 (12.2) | 0.430 |
 Vomiting | 20 (13.4) | 22 (15.0) | 0.704 |
 Diarrhoea | 2 (1.3) | 5 (3.4) | 0.244 |