Table 2 DRAEs with incidence ≥5 % observed in patients from KEYNOTE-001 and KEYNOTE-006
From: Pembrolizumab
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 |