Table 2.
Summary of adverse events.
| Pembrolizumab monotherapy (n = 39) | Pembrolizumab plus acalabrutinib (n = 37) | Total (N = 76) | |
|---|---|---|---|
| AEs (all grades) | 39 (100) | 37 (100) | 76 (100) |
| Grade 3–4 | 15 (38.5) | 24 (64.9) | 45 (59.2) |
| AEs related to pembrolizumab (all grades) | 23 (59.0) | 11 (29.7) | 36 (47.4) |
| Grade 3–4 | 3 (7.7) | 6 (16.2) | 11 (14.5) |
| AEs related to acalabrutinib (all grades) | 0 | 12 (32.4) | 18 (23.7) |
| Grade 3–4 | 0 | 3 (8.1) | 5 (6.6) |
| AEs related to pembrolizumab and acalabrutinib (any grade) | 0 | 19 (51.4) | 23 (30.3) |
| Grade 3–4 | 0 | 6 (16.2) | 6 (7.9) |
| SAEs | 12 (30.8) | 25 (67.6) | 45 (59.2) |
| Related to pembrolizumab | 1 (2.6) | 3 (8.1) | 5 (6.6) |
| Related to acalabrutinib | 0 | 1 (2.7) | 2 (2.6) |
| Related to pembrolizumab and acalabrutinib | 0 | 3 (8.1) | 3 (3.9) |
| AEs leading to study drug modification | 0 | 2 (5.4) | 4 (5.3) |
| AEs leading to study drug delay | 5 (12.8) | 17 (45.9) | 26 (34.2) |
| AEs leading to study drug discontinuation | 3 (7.7) | 7 (18.9) | 16 (21.1) |
| Fatal/grade 5 AEs | 1 (2.6) | 3 (8.1) | 7 (9.2) |
Abbreviations: AE, adverse event; SAE, serious adverse event.
aCrossover is not the originally randomized group. AEs experienced up to crossover date are summarized for pembrolizumab arm; AEs on or after the crossover date are summarized for the crossover group.