Table 2.
DRAEs with incidence ≥5 % observed in patients from KEYNOTE-001 and KEYNOTE-006
| AE, % | Nonrandomized and randomized cohorts KEYNOTE-001 | NSCLC cohorts KEYNOTE-001 | 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 | 36 | 19 | 21 | 19 |
| Pruritus | 24 | 11 | 14 | 14 |
| Rash | 20 | 10 | 15 | 13 |
| Arthralgia | 16 | 9 | 9 | 12 |
| Diarrhea | 16 | 8 | 17 | 14 |
| Nausea | 12 | 8 | 10 | 11 |
| Vitiligo | 11 | NR | 9 | 11 |
| Asthenia | 9 | 5 | 12 | 11 |
| Cough | 9 | 2 | 4 | 4 |
| Myalgia | 9 | 3 | 7 | 2 |
| Headache | 8 | 2 | 3 | 2 |
| Hypothyroidism | 8 | 7 | 10 | 9 |
| Decreased appetite | 7 | 11 | 6 | 7 |
| Dyspnea | 7 | 4 | 1 | 3 |
| Chills | 6 | 2 | 1 | 0 |
| Pyrexia | 6 | 4 | 4 | 1 |
| ALT increase | 5 | 2 | 4 | 1 |
| Pneumonitis | 3 | 4 | <1 | 2 |
| Hyperthyroidism | 1 | 2 | 7 | 3 |
| Colitis | <1 | NR | 2 | 4 |
| Hepatitis | <1 | NR | 1 | 2 |
| Hypophysitis | NR | NR | <1 | <1 |
| Nephritis | NR | NR | 0 | <1 |
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; DRAEs drug-related AEs; NR not reported; NSCLC non-small cell lung cancer