TABLE 2.
TEAEs that occurred in >10% of patients
| Patients (N = 34) | ||||
|---|---|---|---|---|
| Treatment-related TEAES | TEAEs of any cause | |||
| MedDRA preferred term, n (%) | Any grade | Grade ≥3 | Any grade | Grade ≥3 |
| Patients with any TEAEs | 33 (97.1) | 29 (82.4) | 34 (100) | 29 (85.3) |
| Neutropenia | 20 (58.8) | 18 (52.9) | 20 (58.8) | 18 (52.9) |
| Leukopenia | 19 (55.9) | 15 (44.1) | 19 (55.9) | 15 (44.1) |
| Decreased appetite | 19 (55.9) | 3 (8.8) | 20 (58.8) | 3 (8.8) |
| Malaise | 15 (44.1) | 1 (2.9) | 15 (44.1) | 1 (2.9) |
| Aspartate aminotransferase increased | 11 (32.4) | 1 (2.9) | 11 (32.4) | 1 (2.9) |
| Nausea | 10 (29.4) | 0 | 11 (32.4) | 0 |
| Alanine aminotransferase increased | 9 (26.5) | 0 | 9 (26.5) | 0 |
| Febrile neutropenia | 9 (26.5) | 9 (26.5) | 9 (26.5) | 9 (26.5) |
| Thrombocytopenia | 9 (26.5) | 5 (14.7) | 9 (26.5) | 5 (14.7) |
| Pneumonitis | 7 (20.6) | 2 (5.9) | 7 (20.6) | 0 |
| Infusion-related reaction | 6 (17.6) | 0 | 6 (17.6) | 0 |
| Pyrexia | 6 (17.6) | 0 | 11 (32.4) | 0 |
| Anemia | 5 (14.7) | 0 | 7 (20.6) | 1 (2.9) |
| Pruritus | 5 (14.7) | 1 (2.9) | 6 (17.6) | 1 (2.9) |
| Alopecia | 4 (11.8) | 0 | 4 (11.8) | 0 |
| Dysgeusia | 4 (11.8) | 0 | 4 (11.8) | 0 |
| Gamma-glutamyltransferase increased | 4 (11.8) | 0 | 5 (14.7) | 0 |
| Lymphopenia | 4 (11.8) | 2 (5.9) | 4 (11.8) | 2 (5.9) |
| Peripheral sensory neuropathy | 4 (11.8) | 0 | 5 (14.7) | 0 |
| Rash | 4 (11.8) | 0 | 4 (11.8) | 0 |
| Constipation | 3 (8.8) | 0 | 8 (23.5) | 0 |
| Pneumonia | 3 (8.8) | 2 (5.9) | 5 (14.7) | 2 (5.9) |
| Proteinuria | 3 (8.8) | 0 | 4 (11.8) | 0 |
| Rash maculopapular | 3 (8.8) | 0 | 4 (11.8) | 0 |
| Stomatitis | 3 (8.8) | 0 | 5 (14.7) | 0 |
| Urticaria | 3 (8.8) | 1 (2.9) | 4 (11.8) | 1 (2.9) |
| Abdominal pain upper | 2 (5.9) | 0 | 4 (11.8) | 0 |
| Cough | 2 (5.9) | 0 | 8 (23.5) | 1 (2.9) |
| Diarrhea | 2 (5.9) | 0 | 4 (11.8) | 0 |
| Hypokalemia | 2 (5.9) | 0 | 5 (14.7) | 0 |
| Insomnia | 0 | 0 | 5 (14.7) | 0 |
Abbreviation: TEAE, treatment-emergent adverse event.