Table 5 Adverse events reported in ≥ 20% of patients if grade 2 or if grades 3–4 occurring at any frequency
Adverse event, n (%) | Arm A, 100 mg/m2 (n = 79) | Arm B, 125 mg/m2 (n = 79) | ||||||
|---|---|---|---|---|---|---|---|---|
All | Grade 2 | Grade 3 | Grade 4 | All | Grade 2 | Grade 3 | Grade 4 | |
Anaemia | 67 (85) | 26 (33) | 2 (2.5) | – | 66 (83.5) | 29 (37) | – | – |
Leucopaenia | 47 (59) | 20 (25) | 7 (9) | – | 58 (73) | 23 (29) | 15 (19) | 1 (1) |
Neutropaenia | 46 (58) | 18 (23) | 14 (18) | 1 (1) | 55 (67) | 13 (16) | 25 (32) | 3 (4) |
Fatigue | 60 (76) | 25 (32) | 9 (11) | – | 60 (76) | 36 (46) | 4 (5) | – |
Peripheral neuropathy | 43 (54) | 12 (15) | 3 (4) | – | 51 (64.5) | 22 (28) | 8 (10) | – |
Nausea/vomiting | 37 (47) | 8 (10) | 1 (1) | – | 30 (38) | 12 (15) | 2 (2.5) | – |
Alopecia | 35 (44) | 24 (30) | / | / | 32 (40.5) | 21 (27) | / | / |
Myalgia/arthralgia | 33 (42) | 11 (14) | 1 (1) | – | 33 (42) | 9 (11) | – | – |
Dyspnoea | 14 (18) | 4 (5) | – | – | 15 (19) | 1 (1) | 1 (1) | – |
Fever | 14 (18) | 2 (2.5) | – | – | 14 (18) | – | 1 (1) | – |
Hepatotoxicity | 14 (18) | 5 (6) | 2 (2.5) | – | 16 (20) | 1 (1) | 1 (1) | – |
Infection | 16 (20) | 8 (10) | 2 (2.5) | 1 (1) | 8 (10)° | 3 (4) | – | – |
Diarrhoea | 11 (14) | 3 (4) | 4 (5) | – | 15 (19)° | 5 (6) | – | – |
Renal toxicity | 2 (2.5)° | – | 1 (1) | – | 4 (6) | 1 (1) | – | – |
Febrile neutropenia | 1 (1) | / | 1 (1) | – | 2 (2.5) | / | 2 (2.5) | – |