Table 3.
Adverse events occurring in ≥ 10% of the patients
| Event | All grades, n (%) |
Grade 3 and 4, n (%) |
||||
|---|---|---|---|---|---|---|
| MP (n = 424) | CTDa (n = 427) | P* | MP (n = 424) | CTDa (n = 427) | P* | |
| Cytopenia† | 84 (19.8) | 66 (15.5) | .11 | 64 (15.1) | 47 (11.0) | .084 |
| Thromboembolic events‡ | 20 (4.7) | 68 (15.9) | < .0001 | |||
| Sensory neuropathy | 25 (5.9) | 101 (23.7) | < .0001 | 2 (0.5) | 11 (2.6) | .021 |
| Motor neuropathy | 11 (2.6) | 50 (11.7) | < .0001 | 5 (1.2) | 17 (4.0) | .016 |
| Constipation | 76 (17.9) | 175 (41.0) | < .0001 | 5 (1.2) | 15 (3.5) | .039 |
| Infection | 111 (26.2) | 137 (32.1) | .060 | 31 (7.3) | 55 (12.9) | .0086 |
| Rash | 30 (7.1) | 65 (15.2) | .00019 | 3 (0.7) | 7 (1.6) | .34 |
| Elevated AP level‡ | 40 (9.4) | 66 (15.5) | .0093 | |||
AP indicates alkaline phosphatase.
*
Fisher exact test.
†
Cytopenia resulting in dose modification or neutrophil count < 0.5 cells × 109/L.
‡
Data were not collected according to adverse events grade.