Table 2. Treatment-Related Adverse Events of Any Grade Reported in 5% or More Patients and Grade 3/4 Reported in 2 or More Patients in Either Treatment Group.
| Patients | No. (%) | |||
|---|---|---|---|---|
| Nivolumab (n = 182)a | Bevacizumab (n = 165)a | |||
| Any Grade | Grade 3/4 | Any Grade | Grade 3/4 | |
| Any treatment-related adverse event | 103 (56.6) | 33 (18.1) | 95 (57.6) | 25 (15.2) |
| Treatment-related adverse events occurring in ≥5% of patients in either group | ||||
| Fatigue | 38 (20.9) | 6 (3.3) | 23 (13.9) | 0 |
| Hypertension | 1 (0.5) | 0 | 37 (22.4) | 13 (7.9) |
| Nausea | 7 (3.8) | 0 | 9 (5.5) | 0 |
| Rash | 12 (6.6) | 0 | 4 (2.4) | 0 |
| Pruritus | 11 (6.0) | 0 | 2 (1.2) | 0 |
| Diarrhea | 10 (5.5) | 0 | 2 (1.2) | 0 |
| Increased alanine aminotransferase | 10 (5.5) | 4 (2.2) | 0 | 0 |
| Other grade 3/4 treatment-related adverse events occurring in ≥2 patients in either group | ||||
| Headache | 8 (4.4) | 2 (1.1) | 8 (4.8) | 0 |
| Increased lipase | 7 (3.8) | 4 (2.2) | 1 (0.6) | 0 |
| Pulmonary embolism | 1 (0.5) | 1 (0.5) | 6 (3.6) | 5 (3.0) |
| Seizure | 5 (2.7) | 2 (1.1) | 0 | 0 |
| Cerebrovascular accident | 0 | 0 | 4 (2.4) | 2 (1.2) |
| Pneumonitis | 4 (2.2) | 2 (1.1) | 0 | 0 |
| Increased amylase | 3 (1.6) | 2 (1.1) | 1 (0.6) | 0 |
| Hyperglycemia | 2 (1.1) | 2 (1.1) | 0 | 0 |
a
Patients who received study treatment.