Table 3.
Incidence of grade ≥ 3 DRAEs in patients from KEYNOTE-001 and KEYNOTE-006
| AE, % | Nonrandomized and randomized cohorts | NSCLC cohorts | KEYNOTE-006 | KEYNOTE- 006 |
|---|---|---|---|---|
| (n = 411) [16] | (n = 495) [22] | (melanoma, 10 mg/kg Q2W, n = 278) [21] | (melanoma,10 mg/kg Q3W, n = 277) [21] | |
| Fatigue | 2 | <1 | 0 | <1 |
| ALT increase | <1 | <1 | 0 | <1 |
| Colitis | <1 | NR | 1 | 3 |
| Decreased appetite | <1 | 1 | 0 | 0 |
| Diarrhea | <1 | <1 | 3 | 1 |
| Dyspnea | <1 | 4 | 0 | <1 |
| Headache | <1 | NR | 0 | 0 |
| Hepatitis | <1 | NR | 1 | 2 |
| Hyperthyroidism | <1 | NR | 0 | 0 |
| Hypophysitis | <1 | NR | <1 | <1 |
| Hypothyroidism | <1 | <1 | <1 | 0 |
| Nausea | <1 | <1 | 0 | <1 |
| Pneumonitis | <1 | 2 | 0 | <1 |
| Pruritus | <1 | 0 | 0 | 0 |
| Rash | <1 | <1 | 0 | 0 |
| Arthralgia | 0 | <1 | 0 | <1 |
| Asthenia | 0 | 1 | <1 | 0 |
KEYNOTE-001 included melanoma and lung cohorts; KEYNOTE-006 included patients with melanoma
Numbers given as percentages where available
Abbreviations: AE adverse event; ALT alanine aminotransferase; DRAE drug-related AEs; NR not reported; NSCLC non-small cell lung cancer