| |
CheckMate025
|
Italian EAP
|
|---|
|
Everolimus N = 397
|
Nivolumab N = 406
|
Nivolumab N = 389
|
|---|
|
Any grade
|
Grade ≥ 3
|
Any grade
|
Grade ≥ 3
|
Any grade
|
Grade ≥ 3
|
|---|
|
Treatment-related AEs, %
|
88
|
37
|
79
|
19
|
32
|
7
|
|
Fatigue
|
34
|
3
|
33
|
2
|
13
|
2
|
|
Pyrexia
|
NR
|
NR
|
NR
|
NR
|
3
|
0
|
|
Nausea
|
17
|
1
|
14
|
< 1
|
0
|
0
|
|
Pruritus
|
10
|
0
|
14
|
0
|
0
|
0
|
|
Diarrhea
|
21
|
1
|
12
|
1
|
5
|
1
|
|
Decreased appetite
|
21
|
1
|
12
|
< 1
|
1
|
< 1
|
|
Rash
|
20
|
1
|
10
|
< 1
|
9
|
< 1
|
|
Hypothyroidism
|
NR
|
NR
|
NR
|
NR
|
2
|
0
|
|
Hyperthyroidism
|
NR
|
NR
|
NR
|
NR
|
2
|
0
|
|
Hypophisitis
|
NR
|
NR
|
NR
|
NR
|
< 1
|
< 1
|
|
Hypertransaminasemia
|
NR
|
NR
|
NR
|
NR
|
1
|
0
|
|
Cough
|
19
|
0
|
9
|
0
|
0
|
0
|
|
Anemia
|
24
|
8
|
8
|
2
|
2
|
< 1
|
|
Dyspnea
|
13
|
< 1
|
7
|
1
|
3
|
1
|
|
Edema peripheral
|
14
|
< 1
|
4
|
0
|
0
|
0
|
|
Pneumonitis
|
15
|
3
|
4
|
1
|
2
|
< 1
|
|
Mucosal inflammation
|
19
|
3
|
3
|
0
|
0
|
0
|
|
Dysgeusia
|
13
|
0
|
3
|
0
|
0
|
0
|
|
Hyperglycemia
|
12
|
3
|
2
|
1
|
< 1
|
< 1
|
|
Stomatitis
|
29
|
4
|
2
|
0
|
0
|
0
|
|
Hypertriglyceridemia
|
16
|
4
|
1
|
0
|
0
|
0
|
|
Epistaxis
|
10
|
0
|
1
|
0
|
0
|
0
|
- Abbreviations: NR not reported, N number, AEs adverse events, EAP Early Access Program
