| Treatment-related adverse events . | NIVO3 n = 85 No. (%) . | NIVO3 + IPI1 n = 81 No. (%) . | ||
|---|---|---|---|---|
| Any Grade . | Grade 3/4 . | Any Grade . | Grade 3/4 . | |
| Patients with any TRAE | 49 (57.6)a | 12 (14.1) | 52 (64.2)a | 22 (27.2) |
| TRAEs in ≥5% of patients in either moduleb | ||||
| Fatigue | 9 (10.6) | 1 (1.2) | 7 (8.6) | 0 |
| Decreased appetite | 8 (9.4) | 1 (1.2) | 4 (4.9) | 0 |
| ALT increased | 7 (8.2) | 1 (1.2) | 9 (11.1) | 5 (6.2) |
| Abdominal pain | 7 (8.2) | 0 | 3 (3.7) | 0 |
| AST increased | 6 (7.1) | 1 (1.2) | 10 (12.3) | 4 (4.9) |
| Neutrophil count decreased | 6 (7.1) | 3 (3.5) | 1 (1.2) | 1 (1.2) |
| Headache | 6 (7.1) | 0 | 5 (6.2) | 0 |
| Diarrhea | 6 (7.1) | 0 | 5 (6.2) | 1 (1.2) |
| WBC count decreased | 6 (7.1) | 0 | 2 (2.5) | 0 |
| Vomiting | 5 (5.9) | 0 | 7 (8.6) | 0 |
| Nausea | 5 (5.9) | 0 | 4 (4.9) | 0 |
| Rash | 5 (5.9) | 2 (2.4) | 2 (2.5) | 1 (1.2) |
| Weight decreased | 2 (2.4) | 0 | 6 (7.4) | 2 (2.5) |
| Neurological disorders | 14 (16.5) | 1 (1.2) | 11 (13.6) | 1 (1.2) |
| Serious TRAEs | 10 (11.8)a | 5 (5.9) | 20 (24.7) | 13 (16.0) |
| TRAEs leading to discontinuation | 10 (11.8)a | 6 (7.1) | 14 (17.3) | 12 (14.8) |
| Treatment-related adverse events . | NIVO3 n = 85 No. (%) . | NIVO3 + IPI1 n = 81 No. (%) . | ||
|---|---|---|---|---|
| Any Grade . | Grade 3/4 . | Any Grade . | Grade 3/4 . | |
| Patients with any TRAE | 49 (57.6)a | 12 (14.1) | 52 (64.2)a | 22 (27.2) |
| TRAEs in ≥5% of patients in either moduleb | ||||
| Fatigue | 9 (10.6) | 1 (1.2) | 7 (8.6) | 0 |
| Decreased appetite | 8 (9.4) | 1 (1.2) | 4 (4.9) | 0 |
| ALT increased | 7 (8.2) | 1 (1.2) | 9 (11.1) | 5 (6.2) |
| Abdominal pain | 7 (8.2) | 0 | 3 (3.7) | 0 |
| AST increased | 6 (7.1) | 1 (1.2) | 10 (12.3) | 4 (4.9) |
| Neutrophil count decreased | 6 (7.1) | 3 (3.5) | 1 (1.2) | 1 (1.2) |
| Headache | 6 (7.1) | 0 | 5 (6.2) | 0 |
| Diarrhea | 6 (7.1) | 0 | 5 (6.2) | 1 (1.2) |
| WBC count decreased | 6 (7.1) | 0 | 2 (2.5) | 0 |
| Vomiting | 5 (5.9) | 0 | 7 (8.6) | 0 |
| Nausea | 5 (5.9) | 0 | 4 (4.9) | 0 |
| Rash | 5 (5.9) | 2 (2.4) | 2 (2.5) | 1 (1.2) |
| Weight decreased | 2 (2.4) | 0 | 6 (7.4) | 2 (2.5) |
| Neurological disorders | 14 (16.5) | 1 (1.2) | 11 (13.6) | 1 (1.2) |
| Serious TRAEs | 10 (11.8)a | 5 (5.9) | 20 (24.7) | 13 (16.0) |
| TRAEs leading to discontinuation | 10 (11.8)a | 6 (7.1) | 14 (17.3) | 12 (14.8) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; IPI, ipilimumab; NIVO, nivolumab; TRAE, treatment-related adverse event; WBC, white blood cell.
aNo treatment-related deaths were reported.
bOrder based on NIVO3 mg/kg treatment group.
| Treatment-related adverse events . | NIVO3 n = 85 No. (%) . | NIVO3 + IPI1 n = 81 No. (%) . | ||
|---|---|---|---|---|
| Any Grade . | Grade 3/4 . | Any Grade . | Grade 3/4 . | |
| Patients with any TRAE | 49 (57.6)a | 12 (14.1) | 52 (64.2)a | 22 (27.2) |
| TRAEs in ≥5% of patients in either moduleb | ||||
| Fatigue | 9 (10.6) | 1 (1.2) | 7 (8.6) | 0 |
| Decreased appetite | 8 (9.4) | 1 (1.2) | 4 (4.9) | 0 |
| ALT increased | 7 (8.2) | 1 (1.2) | 9 (11.1) | 5 (6.2) |
| Abdominal pain | 7 (8.2) | 0 | 3 (3.7) | 0 |
| AST increased | 6 (7.1) | 1 (1.2) | 10 (12.3) | 4 (4.9) |
| Neutrophil count decreased | 6 (7.1) | 3 (3.5) | 1 (1.2) | 1 (1.2) |
| Headache | 6 (7.1) | 0 | 5 (6.2) | 0 |
| Diarrhea | 6 (7.1) | 0 | 5 (6.2) | 1 (1.2) |
| WBC count decreased | 6 (7.1) | 0 | 2 (2.5) | 0 |
| Vomiting | 5 (5.9) | 0 | 7 (8.6) | 0 |
| Nausea | 5 (5.9) | 0 | 4 (4.9) | 0 |
| Rash | 5 (5.9) | 2 (2.4) | 2 (2.5) | 1 (1.2) |
| Weight decreased | 2 (2.4) | 0 | 6 (7.4) | 2 (2.5) |
| Neurological disorders | 14 (16.5) | 1 (1.2) | 11 (13.6) | 1 (1.2) |
| Serious TRAEs | 10 (11.8)a | 5 (5.9) | 20 (24.7) | 13 (16.0) |
| TRAEs leading to discontinuation | 10 (11.8)a | 6 (7.1) | 14 (17.3) | 12 (14.8) |
| Treatment-related adverse events . | NIVO3 n = 85 No. (%) . | NIVO3 + IPI1 n = 81 No. (%) . | ||
|---|---|---|---|---|
| Any Grade . | Grade 3/4 . | Any Grade . | Grade 3/4 . | |
| Patients with any TRAE | 49 (57.6)a | 12 (14.1) | 52 (64.2)a | 22 (27.2) |
| TRAEs in ≥5% of patients in either moduleb | ||||
| Fatigue | 9 (10.6) | 1 (1.2) | 7 (8.6) | 0 |
| Decreased appetite | 8 (9.4) | 1 (1.2) | 4 (4.9) | 0 |
| ALT increased | 7 (8.2) | 1 (1.2) | 9 (11.1) | 5 (6.2) |
| Abdominal pain | 7 (8.2) | 0 | 3 (3.7) | 0 |
| AST increased | 6 (7.1) | 1 (1.2) | 10 (12.3) | 4 (4.9) |
| Neutrophil count decreased | 6 (7.1) | 3 (3.5) | 1 (1.2) | 1 (1.2) |
| Headache | 6 (7.1) | 0 | 5 (6.2) | 0 |
| Diarrhea | 6 (7.1) | 0 | 5 (6.2) | 1 (1.2) |
| WBC count decreased | 6 (7.1) | 0 | 2 (2.5) | 0 |
| Vomiting | 5 (5.9) | 0 | 7 (8.6) | 0 |
| Nausea | 5 (5.9) | 0 | 4 (4.9) | 0 |
| Rash | 5 (5.9) | 2 (2.4) | 2 (2.5) | 1 (1.2) |
| Weight decreased | 2 (2.4) | 0 | 6 (7.4) | 2 (2.5) |
| Neurological disorders | 14 (16.5) | 1 (1.2) | 11 (13.6) | 1 (1.2) |
| Serious TRAEs | 10 (11.8)a | 5 (5.9) | 20 (24.7) | 13 (16.0) |
| TRAEs leading to discontinuation | 10 (11.8)a | 6 (7.1) | 14 (17.3) | 12 (14.8) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; IPI, ipilimumab; NIVO, nivolumab; TRAE, treatment-related adverse event; WBC, white blood cell.
aNo treatment-related deaths were reported.
bOrder based on NIVO3 mg/kg treatment group.
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