Table 3.
Treatment-related adverse events occurring in ≥10% of patients, or grades 3–4 occurring in ≥2% of patients.
| All grades | Grades 3–4 | |
|---|---|---|
| Adverse event N (%) | ||
| Fatigue | 50 (85) | 1 (2) |
| Nausea | 43 (73) | 0 (0) |
| Alopecia | 39 (66) | 0 (0) |
| Anemia | 35 (59) | 4 (7) |
| Rash | 35 (59) | 1 (2) |
| Diarrhea | 27 (46) | 0 (0) |
| Peripheral sensory neuropathy | 20 (37) | 0 (0) |
| Leukopenia | 16 (27) | 3 (5) |
| Neutropenia | 13 (22) | 4 (7) |
| Vomiting | 12 (20) | 0 (0) |
| Anorexia | 11 (19) | 0 (0) |
| Dyspnea | 9 (15) | 1 (2) |
| Myalgia | 9 (15) | 0 (0) |
| Mucositis | 7 (12) | 1 (2) |
| ALT increased | 7 (12) | 0 (0) |
| Weight loss | 7 (12) | 0 (0) |
| Hypertension | 6 (10) | 0 (0) |
| Cough | 6 (10) | 0 (0) |
| Febrile neutropenia | 3 (5) | 3 (5) |
| Dehydration | 3 (5) | 2 (3) |
| Immune-related adverse events | ||
| Hypothyroidisma | 8 (13) | 0 (0) |
| Hyperthyroidismb | 4 (7) | 0 (0) |
| Adrenal insufficiency | 1 (2) | 0 (0) |
| Diabetes mellitus | 2 (3) | 2 (3) |
| Dermatitis | 12 (20) | 0 (0) |
| Colitis | 4 (7) | 2 (3) |
| Guillan–Barre syndrome | 1 (2) | 1 (2) |
| Optic neuritis | 1 (2) | 0 (0) |
| Pneumonitis | 1 (2) | 0 (0) |
| Arthritis | 1 (2) | 0 (0) |
| Parotitisc | 1 (2) | |
| SAE | 14 | n/a |
SAE serious adverse event.
aTreatment-related adverse events were events that were attributed to a trial treatment by investigators.
bFour patients had both hyperthyroidism and hypothyroidism over the course of their treatment.
cImmune-related adverse event without a grade.