Table 4.
Summary of the most commonly reported adverse events (regardless of causality and reported at any grade in ≥10 % of patients)
| n (%) | All patients (N = 36) | Age ≤65 years (n = 19) | Age >65 years (n = 17) | |||
|---|---|---|---|---|---|---|
| All grades | Grade ≥ 3 | All grades | Grade ≥ 3 | All Grades | Grade ≥ 3 | |
| Patients with ≥ 1 AE | 36 (100.0) | 31 (86.1) | 19 (100.0) | 16 (84.2) | 17 (100.0) | 15 (88.2) |
| Neutropenia | 26 (72.2) | 23 (63.9) | 16 (84.2) | 14 (73.7) | 10 (58.8) | 9 (52.9) |
| Anemia | 17 (47.2) | 15 (41.7) | 9 (47.4) | 8 (42.1) | 8 (47.1) | 7 (41.2) |
| Thrombocytopenia | 17 (47.2) | 11 (30.6) | 11 (57.9) | 6 (31.6) | 6 (35.3) | 5 (29.4) |
| Pyrexia | 9 (25.0) | 0 | 5 (26.3) | 0 | 4 (23.5) | 0 |
| Constipation | 8 (22.2) | 2 (5.6) | 6 (31.6) | 1 (5.3) | 2 (11.8) | 1 (5.9) |
| Nasopharyngitis | 8 (22.2) | 0 | 2 (10.5) | 0 | 6 (35.3) | 0 |
| Lymphopenia | 7 (19.4) | 6 (16.7) | 4 (21.1) | 3 (15.8) | 3 (17.6) | 3 (17.6) |
| Diarrhea | 7 (19.4) | 0 | 5 (26.3) | 0 | 2 (11.8) | 0 |
| Nausea | 7 (19.4) | 0 | 4 (21.1) | 0 | 3 (17.6) | 0 |
| Leukopenia | 6 (16.7) | 4 (11.1) | 3 (15.8) | 2 (10.5) | 3 (17.6) | 2 (11.8) |
| Peripheral edema | 6 (16.7) | 0 | 2 (10.5) | 0 | 4 (23.5) | 0 |
| Rash | 6 (16.7) | 0 | 4 (21.1) | 0 | 2 (11.8) | 0 |
| Insomnia | 6 (16.7) | 0 | 2 (10.5) | 0 | 4 (23.5) | 0 |
| Pneumonia | 5 (13.9) | 3 (8.3) | 1 (5.3) | 0 | 4 (23.5) | 3 (17.6) |
| Decreased appetite | 5 (13.9) | 3 (8.3) | 2 (10.5) | 1 (5.3) | 3 (17.6) | 2 (11.8) |
| Malaise | 5 (13.9) | 0 | 4 (21.1) | 0 | 1 (5.9) | 0 |
| Dysgeusia | 5 (13.9) | 0 | 2 (10.5) | 0 | 3 (17.6) | 0 |
| Hypoxia | 4 (11.1) | 1 (2.8) | 3 (15.8) | 1 (5.3) | 1 (5.9) | 0 |
| Epistaxis | 4 (11.1) | 0 | 2 (10.5) | 0 | 2 (11.8) | 0 |
| Upper respiratory tract infection | 4 (11.1) | 0 | 2 (10.5) | 0 | 2 (11.8) | 0 |
AE adverse event