TABLE 3.
Treatment‐related AEs
| Induction phase | Maintenance phase | |||
|---|---|---|---|---|
| Any AE | 35/40 (87.5) | 9/25 (36.0) | ||
| Gr I–II | 22 (53.7) | 6 (24.0) | ||
| Gr III–IV | 26 (63.4) | 4 (16.0) | ||
| Grade I–II | Grade III–IV | Grade I–II | Grade III–IV | |
| Neutropenia | 7 (17.5) | 18 (45.0) | ||
| Neutropenic fever | 0 (0.0) | 5 (12.5) | ||
| Anemia | 7 (17.5) | 4 (10.0) | ||
| Thrombocytopenia | 9 (22.5) | 1 (2.5) | ||
| Acute kidney injury | 4 (10.0) | 1 (2.5) | ||
| Nausea | 0 (0.0) | 3 (7.5) | ||
| Diarrhea | 2 (5.0) | 0 (0.0) | ||
| Liver function abnormality | 2 (5.0) | 1 (2.5) | ||
| Hiccup | 1 (2.5) | 0 (0.0) | ||
| Anaphylaxis | 0 (0.0) | 1 (2.5) | ||
| Pneumonia | 1 (2.5) | 1 (2.5) | ||
| Hypotension | 1 (2.5) | 0 (0.0) | ||
| Oral thrush | 1 (2.5) | 0 (0.0) | ||
| Polyneuropathy | 0 (0.0) | 1 (2.5) | ||
| Immune‐related AEs | ||||
| Hyperthyroidism | 1 (4.0) | 0 (0.0) | ||
| Hypothyroidism | 1 (4.0) | 0 (0.0) | ||
| Pancreatitis | 0 (0.0) | 1 (4.0) | ||
| Hepatitis | 0 (0.0) | 1 (4.0) | ||
| Pneumonitis | 0 (0.0) | 1 (4.0) | ||
| Colitis | 1 (4.0) | 0 (0.0) | ||
| Adrenal insufficiency | 1 (4.0) | 0 (0.0) | ||
| AKI | 1 (4.0) | 1 (4.0) | ||
| Thrombocytopenia | 1 (4.0) | 0 (0.0) | ||
Abbreviations: AE, adverse events; AKI, acute kidney injury; Gr, grade.