Table 5.
Adverse reactions occurring in ≥10% of patients receiving nivolumab in combination with ipilimumab
| Adverse reaction | N1I3 Q3 arm (n = 49) | |
|---|---|---|
| All grades (%) | Grades 3–4 (%) | |
| Skin and subcutaneous tissue | ||
| Rash | 53 | 8 |
| Pruritus | 53 | 4 |
| Musculoskeletal and connective tissue | ||
| Musculoskeletal pain | 41 | 2 |
| Arthralgia | 10 | 0 |
| Gastrointestinal | ||
| Diarrhea | 39 | 4 |
| Abdominal pain | 22 | 6 |
| Nausea | 20 | 0 |
| Ascites | 14 | 6 |
| Constipation | 14 | 0 |
| Dry mouth | 12 | 0 |
| Dyspepsia | 12 | 2 |
| Vomiting | 12 | 2 |
| Stomatitis | 10 | 0 |
| Abdominal distension | 8 | 0 |
| Respiratory, thoracic, and mediastinal | ||
| Cough | 37 | 0 |
| Dyspnea | 14 | 0 |
| Pneumonitis | 10 | 2 |
| Metabolism and nutrition | ||
| Decreased appetite | 35 | 2 |
| General | ||
| Fatigue | 27 | 2 |
| Pyrexia | 27 | 0 |
| Malaise | 18 | 2 |
| Edema | 16 | 2 |
| Influenza‐like illness | 14 | 0 |
| Chills | 10 | 0 |
| Nervous system | ||
| Headache | 22 | 0 |
| Dizziness | 20 | 0 |
| Endocrine | ||
| Hypothyroidism | 20 | 0 |
| Adrenal insufficiency | 18 | 4 |
| Investigations | ||
| Weight decreased | 20 | 0 |
| Psychiatric | ||
| Insomnia | 18 | 0 |
| Blood and lymphatic system | ||
| Anemia | 10 | 4 |
| Infections | ||
| Influenza | 10 | 2 |
| Upper respiratory tract infection | 6 | 0 |
| Vascular | ||
| Hypotension | 10 | 0 |