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AEs 1L R/M nivolumab or IC after platinum-based
therapy in the primary/adjuvant setting
Received study drug in 1L R/M setting
Nivolumab (n = 51)
Investigator’s choice (n = 25)
Any grade
Grade 3–4
Any grade
Grade 3–4
Any TRAE, n (%)
35 (68.6)
14 (27.5)
18 (72.0)
8 (32.0)
TRAEs in ≥15% of patients, n (%)
Fatigue
Nausea
Asthenia
Mucosal inflammation
Alopecia
9 (17.6)
7 (13.7)
4 (7.8)
1 (2.0)
0
3 (5.9)
0
0
0
0
3 (12.0)
5 (20.0)
5 (20.0)
5 (20.0)
4 (16.0)
0
0
1 (4.0)
0
0
Select TRAEs, n (%)
Skin
Endocrine
Gastrointestinal
Hepatic
Pulmonary
Renal
Hypersensitivity/infusion reactions
10 (19.6)
4 (7.8)
4 (7.8)
3 (5.9)
1 (2.0)
1 (2.0)
2 (3.9)
0
0
1 (2.0)
0
0
0
0
4 (16.0)
0
2 (8.0)
1 (4.0)
1 (4.0)
0
1 (4.0)
1 (4.0)
0
0
0
0
0
1 (4.0)