Table 3. Adverse events (ITT population; n=42).
|
Number (%) of patients |
|||
|---|---|---|---|
| Any grade | Grade 3 | Grade 4–5 | |
| Anemia | 24 (57.1) | 11 (26.2) | 1 (2.4) |
| Thrombocytopenia | 27 (64.3) | 4 (9.5) | 17 (63.1) |
| Neutropenia | 19 (45.2) | 7 (18.7) | 9 (21.4) |
| Cardiac | 2 (4.8) | — | 1a (2.4) |
| Neurological | 1 (2.4) | — | — |
| Gastrointestinal | 10 (23.8) | — | — |
| Hepatic | 2 (4.8) | 1 (2.4) | — |
| Documented infection | 6 (14.3) | 2 (4.8) | 1 (2.4) |
| Bleeding | 9 (21.4) | — | 1a (2.4) |
| Febrile neutropenia | 2 (4.8) | 2 (4.8) | — |
| Other | 8 (19.0) | 1 (2.4) | — |
Abbreviation: ITT, intent-to-treat.
a
Grade 5 event.