Table 3.
Incidence of treatment-related adverse events
| Event | Cases (31 (%)) | |
|---|---|---|
| Any event | 27 (87.1) | |
| Any serious event | 18 (58.1) | |
| Any event leading to discontinuation or withdrawal of ipilimumab only | 1 (3.2) | |
| Any event leading to temporary discontinuation or withdrawal of both trial drugs | 15 (48.4) | |
| Any treatment-related event leading to withdrawal of both study drugs | 3 (9.7) | |
| Immune-related Hepatitis | 2 (6.5) | |
| Immune-related Colitis | 1 (3.2) | |
| Any event leading to patient death | 3 (9.7) | |
| Sepsis | 2 (6.5) | |
| Suicide | 1 (3.2) | |
| Any event occurring in 10% of patients | Any Grade | Grade 3 or 4 |
| Infection or sepsis | 10 (32.2) | 6 (22.5) |
| Nausea | 6 (19.4) | 1 (3.2) |
| Renal impairment | 6 (19.4) | 2 (6.4) |
| Anemia | 5 (16.1) | 0 |
| Vomiting | 5 (16.1) | 1 (3.2) |
| Constipation | 4 (12.9) | 1 (3.2) |
| Diarrhea | 4 (12.9) | 1 (3.2) |
| Fatigue | 4 (12.9) | 0 |
| Deterioration of general condition | 4 (12.9) | 3 (9.7) |
| Hypokalemia | 4 (12.9) | 3 (9.7) |
| Immune-related AEs | 14 (45.2) | 9 (29) |
| Hepatitis | 4 (12.9) | 4 (12.9) |
| Diarrhea / Colitis | 3 (9.7) | 3 (9.7) |
| Hyperthyroidism | 3 (9.7) | 0 |
| Hypophysitis | 1 (3.2) | 1 (3.2) |
| Arthritis | 1 (3.2) | 1 (3.2) |
| Pruritus | 1 (3.2) | 0 |
| Fatigue | 1 (3.2) | 0 |
Source data are provided as a Source Data file.