Table 4 Toxicity and Clinical Events.
Men N = 294 | Women N = 218 | Overall N = 512 | Chi squared test p-value | |
|---|---|---|---|---|
Grade ≥ 3 heamatological toxicity (except anemia) - n (%) | 65 (22.1) | 87 (39.9) | 152 (29.7) | <0.0001 |
Grade ≥ 3 leukopenia - n (%) | 6 (2.0) | 5 (2.3) | 11 (2.1) | |
Grade ≥ 3 febrile neutropenia - n (%) | 4 (1.4) | 6 (2.8) | 10 (2.0) | |
Grade ≥ 3 non-febrile neutropenia - n (%) | 62 (21.1) | 81 (37.2) | 143 (27.9) | |
Grade ≥ 3 thrombocytopenia - n (%) | 1 (0.3) | 4 (1.8) | 5 (1.0) | |
Grade ≥ 3 anemia - n (%) | 1 (0.3) | 1 (0.5) | 2 (0.4) | — |
Grade ≥ 3 gastrointestinal toxicity - n (%) | 24 (8.2) | 31 (14.2) | 55 (10.7) | 0.0286 |
Grade ≥ 3 diarrhea - n (%) | 14 (4.8) | 20 (9.2) | 34 (6.6) | |
Grade ≥ 3 nausea - n (%) | 6 (2.0) | 8 (3.7) | 14 (2.7) | |
Grade ≥ 3 vomiting - n (%) | 5 (1.7) | 6 (2.8) | 11 (2.1) | |
Grade ≥ 3 stomatitis - n (%) | 1 (0.3) | 1 (0.5) | 2 (0.4) | |
Grade ≥ 3 mucositis - n (%) | 1 (0.3) | 3 (1.4) | 4 (0.8) | |
Grade ≥ 2 neurotoxicity - n (%) | 72 (24.5) | 61 (28.0) | 133 (26.0) | 0.3730 |
Grade ≥ 2 ototoxicity - n (%) | 1 (0.3) | 0 (0.0) | 1 (0.2) | |
Grade ≥ 2 central neurotoxicity - n (%) | 9 (3.1) | 7 (3.2) | 16 (3.1) | |
Grade ≥ 2 paresthesia/dysesthesia - n (%) | 63 (21.4) | 55 (25.2) | 118 (23.0) | |
Relapse - n (%) | 50 (17.0) | 32 (14.7) | 82 (16.0) | 0.4776 |
Death - n (%) | 45 (15.3) | 26 (11.9) | 71 (13.9) | 0.2739 |
Relapse or death - n (%) | 67 (22.8) | 39 (17.9) | 106 (20.7) | 0.1761 |