Table 2. Toxic Effects According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03, Occurring in More Than 5% of Patients.
| Grade ≥3 AEs (safety population n = 87) | Patients, No. (%) | |
|---|---|---|
| Trastuzumab/nivolumab/ipilimumab (n = 44) | Trastuzumab/nivolumab/FOLFOX (n = 43) | |
| All grade ≥3 AEs | 36 (82) | 38 (88) |
| Treatment-related AEs | 20 (46) | 29 (67) |
| Leukopenia | 2 (5) | 10 (23) |
| Anemia | 5 (11) | 3 (7) |
| Infection | 5 (11) | 7 (16) |
| Fatigue | 3 (7) | 6 (14) |
| Diarrhea | 6 (14) | 2 (5) |
| Pyrexia | 1 (2) | 3 (7) |
| Neuropathy | 0 | 5 (11) |
| Pulmonary embolism | 3 (7) | 1 (2) |
| Hypertension | 0 | 3 (7) |
| Autoimmune hepatitis | 4 (9) | 0 |
| Colitis | 3 (7) | 0 |
| Pneumonitis | 3 (7) | 0 |
| Endocrine disorders (hypophysitis/thyroiditis) | 3 (7) | 1 (2) |
| SAEs | 34 (77) | 28 (65) |
| Treatment-related SAEs | 17 (39) | 15 (35) |
| Fatal SAEs | 1 (2) | 4 (9) |
| Treatment-related fatal SAEs | 0 | 1 (2) |
Abbreviations: AE, adverse event; SAE, serious AE.