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|
Patients, n (%)
|
Urelumab monotherapy N=23
|
Urelumab + nivolumab N=104
|
|---|
|
Treatment-related AEs
|
65 (53)
|
65 (53)
|
|
Most frequent treatment-related AEsa
| | |
|
Fatigue
|
18 (15)
|
27 (26)
|
|
AST increased
|
16 (13)
|
9 (9)
|
|
ALT increased
|
12 (10)
|
13 (13)
|
|
Treatment-related grade ¾ AST elevation
|
4 (3)
|
3 (3)
|
|
Treatment-related ¾ ALT elevation
|
3 (2)
|
3 (3)
|
|
Treatment-related serious AEs
|
9 (7)
|
10 (10)
|
|
Treatment-related AEs leading to discontinuation
|
6 (5)
|
7 (7)
|
|
Treatment-related deaths
|
0
|
0
|
- AE, adverse event; AKT, alanine aminotransferase; AST, aspartate aminotransferase.
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aTreatment-related AEs occurring in ≥10% of all patients