Table 3.
Incidence of non-haematological adverse events (stratified by grades 1–2, ≥3 during induction + maintenance phase and maintenance phase only; AEs grades 1–2 in at least 10% of patients and all ≥3 events are reported)
| Induction + Maintenance (n = 90) | Maintenance only (n = 41) | |||
|---|---|---|---|---|
| Adverse event, n (%) | Grade 1/2 | Grade ≥ 3 | Grade 1/2 | Grade ≥ 3 |
| Non-haematological | ||||
| Upper respiratory infection | 24 (26.7) | 1 (1.1) | 8 (19.5) | 1 (2.4) |
| Lower respiratory infection | 13 (14.4) | 8 (8.9) | 1 (2.4) | 0 (0.0) |
| Viral infection | 7 (7.8) | 3 (3.3) | 2 (4.9) | 0 (0.0) |
| Urinary tract infection | 1 (1.1) | 2 (2.2) | 0 (0.0) | 1 (2.4) |
| Infection unspecified | 10 (11.1) | 2 (2.2) | 2 (4.9) | 0 (0.0) |
| Varicella zoster virus inf. | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0 (0.0) |
| Sepsis | 0 (0.0) | 1 (1.1) | 0 (0.0) | 0 (0.0) |
| Polyneuropathy | 33 (36.7) | 4 (4.4) | 7 (17.1) | 1 (2.4) |
| Fatigue | 33 (36.7) | 2 (2.2) | 4 (9.8) | 0 (0.0) |
| Constipation | 26 (28.8) | 1 (1.1) | 1 (2.4) | 0 (0.0) |
| Diarrhoea | 8 (8.9) | 3 (3.3) | 1 (2.4) | 1 (2.4) |
| Nausea | 16 (17.8) | 0 (0.0) | 3 (7.3) | 0 (0.0) |
| Oedema | 26 (28.9) | 0 (0.0) | 4 (9.8) | 0 (0.0) |
| Pain | 22 (24.4) | 6 (6.7) | 9 (22.0) | 0 (0.0) |
| Renal disorders | 2 (2.2) | 2 (2.2) | 0 (0.0) | 0 (0.0) |
| Cardiac disorders | 4 (4.4) | 2 (2.2) | 0 (0.0) | 1 (2.4) |
| Secondary malignancies | 1 (1.1) | 2 (2.2) | 0 (0.0) | 0 (0.0) |
| Haematological | ||||
| Anaemia | 66 (73.3) | 16 (17.8) | 34 (82.9) | 4 (9.6) |
| Leukopenia | 46 (51.1) | 5 (5.6) | 28 (68.3) | 1 (2.4) |
| Neutropenia | 35 (38.9) | 2 (2.2) | 17 (41.5) | 0 (0.0) |
| Thrombocytopenia | 36 (40) | 7 (7.8) | 17 (41.5) | 3 (7.3) |