Table 2.
Overview of Adverse Events
| Adverse Event | Canakinumab (n = 35) |
Canakinumab + Pembrolizumab (n = 35) |
Pembrolizumab (n = 18) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| All grades, n (%) | Grade 3/4, n (%) | Grade 5, n (%) | All grades, n (%) | Grade 3/4, n (%) | Grade 5, n (%) | All grades, n (%) | Grade 3/4, n (%) | Grade 5, n (%) | |
| All deaths | 3 (8.6) | 0 | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (5.6) | 0 | 1 (5.6) |
| On-treatment deaths | 3 (8.6) | 0 | 3 (8.6) | 2 (5.7) | 0 | 1 (2.9) | 1 (5.6) | 0 | 1 (5.6) |
| Adverse events | 31 (88.6) | 10 (28.6) | 3 (8.6) | 32 (91.4) | 9 (25.7) | 1 (2.9) | 15 (83.3) | 3 (16.7) | 1 (5.6) |
| Treatment related | 13 (37.1) | 0 | 0 | 13 (37.1) | 4 (11.4) | 0 | 9 (50.0) | 2 (11.1) | 0 |
| SAEs | 10 (28.6) | 6 (17.1) | 3 (8.6) | 9 (25.7) | 4 (11.4) | 1 (2.9) | 4 (22.2) | 3 (16.7) | 1 (5.6) |
| Treatment related | 0 | 0 | 0 | 2 (5.7) | 2 (5.7) | 0 | 1 (5.6) | 1 (5.6) | 0 |
| Fatal SAEs | 3 (8.6) | 0 | 3 (8.6) | 1 (2.9) | 0 | 1 (2.9) | 1 (5.6) | 0 | 1 (5.6) |
| Treatment related | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs leading to any drug discontinuation | 0 | 0 | 0 | 1 (2.9) | 1 (2.9) | 0 | 1 (5.6) | 1 (5.6) | 0 |
| Treatment related | 0 | 0 | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 |
| AEs leading to canakinumab discontinuation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| AEs leading to any dose interruption | 0 | 0 | 0 | 1 (2.9) | 1 (2.9) | 0 | 0 | 0 | 0 |
| AEs requiring additional therapy | 19 (54.3) | 7 (20.0) | 2 (5.7) | 25 (71.4) | 7 (20.0) | 1 (2.9) | 11 (61.1) | 4 (22.2) | 0 |
| Treatment related | 1 (2.9) | 0 | 0 | 13 (37.1) | 4 (11.4) | 0 | 4 (22.2) | 2 (11.1) | 0 |
| All imAEs | 0 | 0 | 0 | 9 (25.7) | 1 (2.9) | 0 | 3 (16.7) | 1 (5.6) | 0 |
| imAEs requiring additional therapy: | 0 | 0 | 0 | 8 (22.9) | 1 (2.9) | 0 | 2 (11.1) | 1 (5.6) | 0 |
| Steroids | 0 | 0 | 0 | 3 (8.6) | 1 (2.9) | 0 | 0 | 0 | 0 |
| Hormonal therapy | 0 | 0 | 0 | 5 (14.3) | 0 | 0 | 2 (11.1) | 1 (5.6) | 0 |
AE, adverse event; imAE, immune-mediated AE; SAE, serious AE.