Events of clinical interest
Event, n (%) ECI category ECI subcategory . | N = 21 . | |
|---|---|---|
| All grades . | Grades ≥3 . | |
| Cardiac events∗ | 5 (23.8) | 0 |
| Atrial fibrillation | 0 | 0 |
| Ventricular tachyarrhythmias | 0 | 0 |
| Leukopenia | 12 (57.1) | 9 (42.9) |
| Neutropenia | 10 (47.6) | 8 (38.1) |
| Other leukopenia | 4 (19.0) | 2 (9.5) |
| Thrombocytopenia | 1 (4.8) | 0 |
| Hemorrhage† | 7 (33.3) | 0 |
| Hepatotoxicity | 1 (4.8) | 0 |
| Hypertension | 1 (4.8) | 1 (4.8) |
| Infections‡ | 14 (66.7) | 8 (38.1) |
| Interstitial lung disease/pneumonitis | 1 (4.8) | 0 |
| Second primary malignancies | 1 (4.8) | 0 |
| Second primary malignancies (excluding skin) | 1 (4.8) | 0 |
Event, n (%) ECI category ECI subcategory . | N = 21 . | |
|---|---|---|
| All grades . | Grades ≥3 . | |
| Cardiac events∗ | 5 (23.8) | 0 |
| Atrial fibrillation | 0 | 0 |
| Ventricular tachyarrhythmias | 0 | 0 |
| Leukopenia | 12 (57.1) | 9 (42.9) |
| Neutropenia | 10 (47.6) | 8 (38.1) |
| Other leukopenia | 4 (19.0) | 2 (9.5) |
| Thrombocytopenia | 1 (4.8) | 0 |
| Hemorrhage† | 7 (33.3) | 0 |
| Hepatotoxicity | 1 (4.8) | 0 |
| Hypertension | 1 (4.8) | 1 (4.8) |
| Infections‡ | 14 (66.7) | 8 (38.1) |
| Interstitial lung disease/pneumonitis | 1 (4.8) | 0 |
| Second primary malignancies | 1 (4.8) | 0 |
| Second primary malignancies (excluding skin) | 1 (4.8) | 0 |
ECI, event of clinical interest.
Cardiac events included 2 patients with tachycardia (both grade 2), 1 patient with cardiac failure and mitral and tricuspid valve incompetence (all grade 1), 1 patient with pericarditis (grade 1) and chronic cardiac failure (grade 2), and 1 patient with arrhythmia (grade 2).
Hemorrhage was reported in 1 patient with petechiae (grade 1), 2 patients with hemorrhagic diathesis (both grade 1), 3 patients with contusion (n = 3, grade 1; n = 1, grade 2), and 1 patient with epistaxis (grade 1).
Six of the 8 grade ≥3 infections were related to COVID-19: 4 were grade 5 and 2 were grade 3.