Table 4.
Treatment‐emergent adverse events of grade 3/4/5 by treatment group in at least ≥2% of patients (all treated patients) as reported by the investigators
| Grade 3/4/5 TEAEs as per NCI‐CTC; worst grade | Full analysis set (n = 218), n (%) |
|---|---|
| Patients with any grade 3/4/5 TEAE | |
| Any grade | 117 (53.7) |
| Grade 3 | 77 (35.3) |
| Grade 4 | 38 (17.4) |
| Grade 5 | 2 (0.9) |
| Hematologic | |
| Neutropenia | |
| Any grade | 66 (30.3) |
| Grade 3 | 37 (17.0) |
| Grade 4 | 29 (13.3) |
| Anemia | |
| Any grade | 14 (6.4) |
| Grade 3 | 14 (6.4) |
| Thrombocytopenia | |
| Any grade | 12 (5.5) |
| Grade 3 | 8 (3.7) |
| Grade 4 | 4 (1.8) |
| Leukopenia | |
| Any grade | 9 (4.1) |
| Grade 3 | 7 (3.2) |
| Grade 4 | 2 (0.9) |
| Febrile neutropenia | |
| Any grade | 8 (3.7) |
| Grade 3 | 5 (2.3) |
| Grade 4 | 3 (1.4) |
| Nonhematologic | |
| Vomiting | |
| Any grade | 9 (4.1) |
| Grade 3 | 8 (3.7) |
| Grade 4 | 0 |
| Grade 5 | 1 (0.5) |
| Asthenia | |
| Any grade | 11 (5.0) |
| Grade 3 | 11 (5.0) |
| Investigations | |
| Neutrophil count decreased | |
| Any grade | 10 (4.6) |
| Grade 3 | 7 (3.2) |
| Grade 4 | 3 (1.4) |
Abbreviations: NCI‐CTC, National Cancer Institute Common Terminology Criteria; TEAE, treatment‐emergent adverse event.