|
Event
|
Ipilimumab 3 mg/kg (n = 40)
|
Ipilimumab 10 mg/kg (n = 42)
|
|---|
|
Death, n (%)
| | |
|
All
|
18 (45.0)
|
20 (47.6)
|
|
Within 70 days of last dose
|
8 (20.0)
|
8 (19.0)
|
|
Within 30 days of last dose
|
3 (7.5)
|
4 (9.5)
|
|
Serious AE, n (%)
| | |
|
All
|
18 (45.0)
|
20 (47.6)
|
|
Drug-related
|
7 (17.5)
|
8 (19.0)
|
|
AE leading to study discontinuation, n (%)
|
5 (12.5)
|
11 (26.2)
|
|
Drug-related AE, n (%)
| | |
|
Any grade
|
33 (82.5)
|
32 (76.2)
|
|
Grade 3-4
|
6 (15.0)
|
13 (31.0)
|
|
Grade 5
|
1 (2.5)
|
1 (2.4)
|
|
irAE, n (%)
| | |
|
Overall
| | |
|
Any grade
|
22 (55.0)
|
28 (66.7)
|
|
Grade 3-4
|
3 (7.5)
|
8 (19.0)
|
|
Grade 5
|
1 (2.5)
|
1 (2.4)
|
|
GI
| | |
|
Any grade
|
11 (27.5)
|
19 (45.2)
|
|
Grade 3-4
|
3 (7.5)
|
3 (7.2)
|
|
Grade 5
|
1 (2.5)
|
1 (2.4)
|
|
Liver
| | |
|
Any grade
|
0
|
2 (4.8)
|
|
Grade 3-4
|
0
|
2 (4.8)
|
|
Endocrine
| | |
|
Any grade
|
2 (5.0)
|
2 (4.8)
|
|
Grade 3-4
|
0
|
2 (4.8)
|
|
Skin
| | |
|
Any grade
|
16 (40.0)
|
21 (50.0)
|
|
Grade 3-4
|
0
|
1 (2.4)
|
|
Other
| | |
|
Any grade
|
1 (2.5)
|
3 (7.1)
|
|
Grade 3-4
|
0
|
1 (2.4)
|
- AE: adverse event; GI: gastrointestinal; irAE: immune-related adverse event.
