Table 3: AE summary.
|
Total Population N = 159 |
|
|
Any AE |
153 (96.2) |
|
Grade 3-5 |
93 (58.5) |
|
Resulted in treatment discontinuation |
31 (19.5) |
|
Serious |
87 (54.7) |
|
Resulted in death |
20 (12.6) |
|
Any treatment-related AE |
112 (70.4) |
|
Grade 3-5 |
18 (11.3) |
|
Resulted in treatment discontinuation |
14 (8.8) |
|
Serious |
16 (10.1) |
|
Resulted in death |
2 (1.3) |
|
Immune-mediated AEsa |
37 (23.3) |
|
Grade 3-5 |
14 (8.8) |
|
Required systemic corticosteroids |
18 (11.3) |
|
High starting dose |
11 (6.9) |
|
Low starting dose |
7 (4.4) |
AE: Adverse Event
aBased on a list of preferred terms intended to capture known risks of pembrolizumab and were considered regardless of attribution to study treatment by the investigator