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Table 3 Incidence of grade ≥ 3 DRAEs in patients from KEYNOTE-001 and KEYNOTE-006

From: Pembrolizumab

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
  1. KEYNOTE-001 included melanoma and lung cohorts; KEYNOTE-006 included patients with melanoma
  2. Numbers given as percentages where available
  3. Abbreviations: AE adverse event; ALT alanine aminotransferase; DRAE drug-related AEs; NR not reported; NSCLC non-small cell lung cancer