Table 2.
Summary of adverse events
| Adverse eventa | Nivolumab 480 mg Q4W (n = 524) | Placebo Q4W (n = 264) | ||
|---|---|---|---|---|
| Any grade | Grade 3 or 4 | Any grade | Grade 3 or 4 | |
| Any adverse event, n (%) | 502 (95.8)b | 115 (21.9) | 229 (86.7)c | 32 (12.1) |
| Led to discontinuation of treatment | 91 (17.4) | 37 (7.1) | 9 (3.4) | 2 (0.8) |
| Treatment-related adverse event, n (%) | 433 (82.6) | 54 (10.3) | 142 (53.8) | 6 (2.3) |
| Led to discontinuation of treatment | 77 (14.7) | 29 (5.5) | 7 (2.7) | 2 (0.8) |
| Treatment-related adverse event in ≥5% of patientsd, n (%) | ||||
| Fatigue | 106 (20.2) | 0 | 53 (20.1) | 1 (0.4) |
| Pruritus | 97 (18.5) | 1 (0.2) | 25 (9.5) | 0 |
| Diarrhea | 80 (15.3) | 4 (0.8) | 25 (9.5) | 0 |
| Rash | 57 (10.9) | 4 (0.8) | 18 (6.8) | 0 |
| Hypothyroidism | 54 (10.3) | 0 | 0 | 0 |
| Arthralgia | 54 (10.3) | 1 (0.2) | 15 (5.7) | 0 |
| Nausea | 39 (7.4) | 0 | 7 (2.7) | 0 |
| Asthenia | 38 (7.3) | 0 | 18 (6.8) | 0 |
| Dry mouth | 36 (6.9) | 0 | 7 (2.7) | 0 |
| Hyperthyroidism | 36 (6.9) | 1 (0.2) | 3 (1.1) | 0 |
| Increased alanine aminotransferase | 33 (6.3) | 4 (0.8) | 13 (4.9) | 0 |
| Increased aspartate aminotransferase | 30 (5.7) | 6 (1.1) | 6 (2.3) | 1 (0.4) |
| Increased blood creatine phosphokinase | 30 (5.7) | 6 (1.1) | 13 (4.9) | 0 |
| Myalgia | 28 (5.3) | 0 | 14 (5.3) | 0 |
| Infusion-related reaction | 27 (5.2) | 0 | 2 (0.8) | 0 |
| Treatment-related deathe, n (%) | 1 (0.2) | 0 | ||
aThe safety population included all patients who received at least one dose of trial drug. The investigators determined whether adverse events were related to a trial drug. The events listed here occurred between the first dose and either 30 d after the last dose (adverse events and treatment-related adverse events) or 100 d after the last dose (treatment-related deaths). The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
bIncluding one patient with a grade 5 adverse event of myocardial ischemia.
cIncluding one patient with a grade 5 adverse event of ‘sudden death’.
dOccurring in ≥5% of the patients in either treatment group.
eThere was one treatment-related death due to acute kidney injury and heart failure (not related to myocarditis).
Q4W, every 4 weeks.