Table 2

Summary of adverse events

Chemotherapy only
(N=33)
Chemotherapy plus ipilimumab and Nivolumab
(N=49)
Ipilimumab and nivolumab only cross-over
(N=16)
All grades
N (%)
Grade ≥3
N (%)
All grades
N (%)
Grade ≥3
N (%)
All grades
N (%)
Grade ≥3
N (%)
Any AE33 (100)16 (48)49 (100)41 (84)15 (94)4 (25)
Any TRAE32 (97)13 (39)48 (98)36 (73)14 (88)3 (19)
Any SAE13 (39)4 (12)31 (63)26 (53)5 (31)3 (19)
Immune-related adverse events (irAE)
Any irAE1 (3)032 (65)15 (31)8 (50)3 (19)
Thyroid events1 (3)022 (45)1 (2)2 (13)0
Adrenocortical insufficiency/hypophysitis005 (10)5 (10)2 (13)0
Pneumonitis004 (8)1 (2)1 (6)0
Hepatitis003 (6)3 (6)2 (13)1 (6)
Colitis/diarrhoea003 (6)2 (4)2 (13)1 (6)
Type 1 diabetes mellitus002 (4)2 (4)00
Pancreatitis/lipase increased002 (4)2 (4)00
Rash001 (2)1 (2)1 (6)1 (6)
Nephritis001 (2)000
Most common adverse events
Fatigue16 (48)1 (3)27 (55)4 (8)6 (38)0
Lymphocyte count decreased15 (45)7 (21)32 (65)18 (37)00
Rash13 (39)3 (9)27 (55)8 (16)5 (31)1 (6)
Nausea16 (48)026 (53)2 (4)2 (13)0
Constipation18 (55)1 (3)16 (33)000
Stomatitis12 (36)1 (3)20 (41)1 (2)2 (13)0
PPE10 (30)016 (33)2 (4)00
Neutrophil count decreased10 (30)5 (15)11 (22)3 (6)1 (6)0
Musculoskeletal pain2 (6)011 (22)05 (31)0
Fever2 (6)08 (16)2 (4)4 (25)0
Pruritus2 (6)03 (6)05 (31)0
  • Adverse events in the FAS population are graded according to NCI CTCAE V.4.0 and presented as N (%) by treatment arm. Individual adverse events are listed regardless of relation to study therapy. Repeated adverse events in the same subject are counted only once. The table includes all immune-related adverse events, defined as ‘adverse events of special interest’ according to the protocol, and all adverse events occurring in ≥25% of patients in any treatment group.

  • AE, adverse event; CTCAE, Common Terminology Criteria for Adverse Events; FAS, full analysis set; NCI, National Cancer Institute; PPE, palmar-plantar erythrodysesthesia syndrome; SAE, serious AE; TRAE, treatment-related adverse event.