Table 3.
Adverse events grade 2–4 during induction treatment.
| CTCAE grade n (%) | 2 | 3 | 4 |
|---|---|---|---|
| Any hematologic AE | 17 (26) | 6 (9) | 2 (3) |
| Anemia | 7 (11) | 2 (3) | – |
| Thrombocytopenia | 8 (12) | 3 (5) | – |
| Neutropenia | 15 (23) | 2 (3) | 2 (3) |
| Any non-hematologic AE | 28 (43) | 30 (46) | 3 (5)b |
| Cardiac | 3 (5) | 1 (2) | 2 (4)a |
| Central nervous system | 7 (11) | 7 (11)d | – |
| Gastro-intestinal | 14 (22) | 9 (14) | – |
| Infections | 18 (28) | 6 (9) | – |
| Infusion related reactions | 2 (3) | 2 (3) | – |
| Pain | 14 (22) | 4 (6) | – |
| Peripheral neuropathyc | 10 (15) | 5 (8) | – |
| Secondary primary malignancy | 3 (5) | 2 (3) | 1 (2)a |
AEs of grade ≥3 that occurred in at least 5% of patients and AEs of special interest are reported.
a
Including 1 patient with grade 5 AE.
b
Including 2 patients with grade 5 AE.
c
Grade 1 peripheral neuropathy was observed in 12 (18%) patients.
d
2 gait disturbance, 2 syncope, 1 Guillain-Barré syndrome, 1 brain stem infarction, 1 carpal tunnel syndrome AE: adverse event; CTCAE: National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.016; n: number.