Table 2.
Grade 3 or higher treatment-related toxicities in at least 4% of patients on either arm.
| Event | Ipilimumab (N=23) | Nivolumab + Ipilimumab (N=68) |
|---|---|---|
| Diarrhea | 3 (13%) | 9 (13%) |
| AST Increased | 2* (7%) | 5 (7%) |
| ALT Increased | 2* (7%) | 5 (7%) |
| Rash | 1 (4%) | 4 (6%) |
| Fatigue | 1 (4%) | 4 (6%) |
| Anemia | 0 (0%) | 4 (6%) |
| Hypotension | 0 (0%) | 4 (6%) |
| Hyponatremia | 1 (4%) | 4* (6%) |
| Pruritus | 0 (0%) | 3 (4%) |
| Vomiting | 0 (0%) | 3 (4%) |
| Endocrine Disorders (Other) | 0 (0%) | 3 (4%) |
| Alkaline Phosphatase Increased | 1 (4%) | 2 (3%) |
| Colitis | 0 (0%) | 3* (4%) |
| Hypokalemia | 0 (0%) | 3* (4%) |
| Adrenal Insufficiency | 1 (4%) | 3* (4%) |
| Atrial Fibrillation | 1 (4%) | 1 (1%) |
| Bilirubin Increased | 1 (4%) | 0 (0%) |
| Hypophosphatemia | 1 (4%) | 0 (0%) |
| Hyperglycemia | 1* (4%) | 0 (0%) |
| Colonic Perforation | 1 (4%) | 0 (0%) |
*
1 each of these events was grade 4.
Legend. All adverse events reported were assessed as possibly, probably, or definitely related to study treatment. To be included in the safety analysis, patients must have received at least one dose of protocol therapy. Adverse event severity was scored using NCI Common Terminology Criteria for Adverse Events version 4.0. One patient in the ipilimumab arm had a grade 5 Adverse Event (death) due to colonic perforation. One patient in the nivolumab plus ipilimumab arm had a grade 5 Adverse Event (death) due to disseminated intravascular coagulation.