Table 2.

Treatment-related AEs of grade 1–4 severity that occurred in ≥10% of patients; presented by frequency at any grade and by maximum toxicity grade.

Pembrolizumab 200 mg Q3WPembrolizumab 200 mg Q3W
+ ipilimumab 50 mg Q6W+ ipilimumab 100 mg Q12W
(n = 51)(n = 51)
Treatment-related adverse event, n (%)Any gradeGrade 1/2Grade 3Grade 4Any gradeGrade 1/2Grade 3Grade 4
Any51 (100)39 (77)6 (12)5 (10)49 (96)29 (57)18 (35)2 (4)
Fatigue29 (57)29 (57)0 (0)0 (0)26 (51)26 (51)0 (0)0 (0)
Pruritus16 (31)16 (31)0 (0)0 (0)27 (53)27 (53)0 (0)0 (0)
Rash20 (39)20 (39)0 (0)0 (0)21 (41)21 (41)0 (0)0 (0)
Diarrhea13 (25)12 (24)1 (2)0 (0)18 (35)18 (35)0 (0)0 (0)
Arthralgia12 (24)12 (24)0 (0)0 (0)11 (22)10 (20)1 (2)0 (0)
Nausea8 (16)8 (16)0 (0)0 (0)12 (24)12 (24)0 (0)0 (0)
Lipase increased5 (10)0 (0)2 (4)3 (6)10 (20)2 (4)6 (12)2 (4)
Hypothyroidism7 (14)7 (14)0 (0)0 (0)9 (18)9 (18)0 (0)0 (0)
Rash pruritic5 (10)5 (10)0 (0)0 (0)9 (18)9 (18)0 (0)0 (0)
Aspartate aminotransferase increased7 (14)7 (14)0 (0)0 (0)4 (8)4 (8)0 (0)0 (0)
Alanine aminotransferase increased7 (14)7 (14)0 (0)0 (0)2 (4)2 (4)0 (0)0 (0)
Vitiligo6 (12)6 (12)0 (0)0 (0)7 (14)7 (14)0 (0)0 (0)
Dry mouth5 (10)5 (10)0 (0)0 (0)7 (14)7 (14)0 (0)0 (0)
Amylase increased2 (4)1 (2)1 (2)0 (0)7 (14)5 (10)2 (4)0 (0)
Decreased appetite6 (12)6 (12)0 (0)0 (0)6 (12)5 (10)1 (2)0 (0)
Myalgia4 (8)4 (8)0 (0)0 (0)6 (12)5 (10)1 (2)0 (0)
Asthenia5 (10)5 (10)0 (0)0 (0)3 (6)3 (6)0 (0)0 (0)
Rash macular5 (10)5 (10)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)
  • Note: One patient died from a treatment-related adverse event (autoimmune myocarditis, grade 5). Data are presented in order of descending total frequency.

  • Abbreviations: Q3W, every 3 weeks; Q6W, every 6 weeks; Q12W, every 12 weeks.