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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