Table 3.

Treatment-related adverse events

Ipilimumab (n = 57)Active BSC (n = 45)
EventAny, n (%)Grade 3/4, n (%)Any, n (%)Grade 3/4, n (%)
Any TRAE41 (71.9)13 (22.8)25 (55.6)4 (8.9)
TRAEs reported in ≥10% of patients
 Pruritus18 (31.6)0 (0.0)1 (2.2)0 (0.0)
 Diarrhea14 (24.6)5 (8.8)3 (6.7)0 (0.0)
 Fatigue13 (22.8)3 (5.3)3 (6.7)0 (0.0)
 Rash10 (17.5)0 (0.0)2 (4.4)0 (0.0)
 Nausea7 (12.3)0 (0.0)8 (17.8)0 (0.0)
 Asthenia6 (10.5)2 (3.5)1 (2.2)1 (2.2)
 Hypothyroidism6 (10.5)2 (3.5)0 (0.0)0 (0.0)
 Vomiting6 (10.5)0 (0.0)1 (2.2)0 (0.0)
 Palmar-plantar erythrodysesthesia syndrome3 (5.3)0 (0.0)7 (15.6)2 (4.4)
Any treatment-related SAE17 (29.8)13 (22.8)0 (0.0)0 (0.0)
 Diarrhea7 (12.3)5 (8.8)0 (0.0)0 (0.0)
 Colitis3 (5.3)3 (5.3)0 (0.0)0 (0.0)
 Fatigue2 (3.5)2 (3.5)0 (0.0)0 (0.0)
 Hypothyroidism2 (3.5)2 (3.5)0 (0.0)0 (0.0)
 Acute hepatitis1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Asthenia1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Decreased appetite1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Dehydration1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Endocrine disorder1 (1.8)0 (0.0)0 (0.0)0 (0.0)
 Hypopituitarism1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Myalgia1 (1.8)0 (0.0)0 (0.0)0 (0.0)
 Performance status decreased1 (1.8)1 (1.8)0 (0.0)0 (0.0)
 Peripheral sensory neuropathy1 (1.8)0 (0.0)0 (0.0)0 (0.0)