Skip to main content

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
  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; DRAEs drug-related AEs; NR not reported; NSCLC non-small cell lung cancer