Table 3

Selected TRAEs

EventIpilimumab (N=9)Ipilimumab plus nivolumab (N=10)Total (N=19)
Any gradeGrade 3 or 4Any gradeGrade 3 or 4Any gradeGrade 3 or 4
Any TRAE9 (100)5 (56)9 (90)4 (40)18 (95)9 (47)
 Pruritus5 (56)05 (50)010 (53)0
 Maculopapular rash3 (33)04 (40)07 (37)0
 Diarrhea3 (33)1 (11)6 (60)2 (20)9 (47)3 (16)
 Colitis2 (22)2 (22)1 (10)03 (16)2 (11)
 Alanine aminotransferase increased2 (22)05 (50)1 (10)7 (37)1 (5)
 Aspartate aminotransferase increased1 (11)04 (40)1 (10)5 (26)1 (5)
 Hyponatremia2 (22)1 (11)2 (20)04 (21)1 (5)
 Hypokalemia2 (22)1 (11)1 (10)1 (10)3 (16)2 (11)
 Arthralgia2 (22)01 (10)03 (16)0
 Hypophysitis1 (11)03 (30)04 (21)0
 Adrenal insufficiency1 (11)1 (11)001 (5)1 (5)
 White blood cell count decreased2 (22)1 (11)1 (10)03 (16)1 (5)
 Neutrophil count decreased1 (11)1 (11)1 (10)02 (11)1 (5)
 Urinary tract infection1 (11)1 (11)001 (5)1 (5)
 Hypotension002 (20)1 (10)2 (11)1 (5)
TRAE leading to discontinuation1 (11)1 (11)4 (40)05 (26)1 (5)
  • TRAE, treatment-related adverse event.