Table 7. Nonhaematologic toxicity.
|
Arm A |
Arm B |
Arm C |
Arm D |
|||||
|---|---|---|---|---|---|---|---|---|
| All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | All grades | Grade 3–4 | |
| Toxicity type | % of patients | |||||||
| Gastrointestinal origin | ||||||||
| Diarrhoea | 88 | 10 | 76 | 24 | 74 | 13 | 77 | 25 |
| Nausea | 73 | 15 | 73 | 5 | 65 | 9 | 80 | 23 |
| Vomiting | 54 | 10 | 57 | 3 | 50 | 9 | 59 | 16 |
| Gastrointestinal pain | 17 | 2 | 16 | 3 | 17 | 2 | 23 | 2 |
| Anorexia | 12 | — | 14 | — | 17 | — | 34 | 5 |
| Other | ||||||||
| Fatigue | 51 | 7 | 38 | 3 | 61 | 4 | 52 | 7 |
| Fever in absence of infection | 12 | 2 | 19 | - | 15 | 4 | 16 | — |
| Infection | 7 | 2 | 11 | 5 | 11 | — | 11 | 7 |
| Cholinergic syndrome | 68a | — | 41a | — | 61a | 2 | 7a | — |
| Alopecia | 71b | — | 43 | — | 67b | — | 34b | — |
Toxicity is expressed as % of patients with adverse events possibly or probably related to study drug medication; worst grade during study. N=41 in arm A, 37 in arm B, 46 in arm C and 44 in arm D.
Arm D is significantly different from arm A, B and C (P⩽0.001).
Arm D is significantly different from arm A and C (P<0.001).