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|
Outcome
|
Number of patients (%)
|
|---|
| |
N = 103
| |
|---|
|
All grades
|
Grade 3 or 4
|
Grade 5
|
|---|
|
TEAEs
|
99 (96)
|
38 (37)
|
3 (3)
|
|
Study drug-related TEAEs
|
87 (84)
|
16 (16)
|
0
|
|
Related TEAEs with rate ≥ 10%
| | | |
|
Decreased white blood cell count
|
17 (17)
|
0
|
0
|
|
Asthenia
|
17 (17)
|
0
|
0
|
|
Rash
|
16 (16)
|
1 (1)
|
0
|
|
Hypothyroidism
|
16 (16)
|
0
|
0
|
|
Hyperthyroidism
|
12 (12)
|
0
|
0
|
|
Decreased neutrophil count
|
12 (12)
|
1 (1)
|
0
|
|
Anemia
|
12 (12)
|
5 (5)
|
0
|
|
SAEs
|
27 (26)
|
20 (19)
|
3 (3)
|
|
Related SAEs
|
10 (10)
|
9 (9)
|
0
|
|
Related TEAEs leading to discontinuation
|
3 (3)
|
3 (3)
|
0
|
|
irAEs
|
44 (43)
|
8 (8)
|
0
|
|
irAEs leading to discontinuation
|
3 (3)
|
3 (3)
|
0
|
|
Injection site reactions
|
9 (9)
|
0
|
0
|
|
Injection site pain
|
2 (2)
|
0
|
0
|
|
Injection site reaction
|
6 (6)
|
0
|
0
|
|
Injection site swelling
|
1 (1)
|
0
|
0
|
- AE, adverse event; irAE, immune-related adverse event; SAE, serious adverse event; TEAE, treatment-emergent adverse event
