Table 4.
Summary of adverse events in Japanese patients from the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 studies
| n (%) | KEYNOTE-059 | KEYNOTE-061 | KEYNOTE-062 | ||
|---|---|---|---|---|---|
| All patients | All patients | All patients | |||
| Pembrolizumab | Pembrolizumab | Chemotherapy | Pembrolizumab | Chemotherapy | |
| n = 34 | n = 47 | n = 50 | n = 38 | n = 32 | |
| ≥ 1 AE | 30 (88) | 41 (87) | 48 (96) | 36 (95) | 32 (100) |
| TRAE | 20 (59) | 23 (49) | 46 (92) | 22 (58) | 30 (94) |
| Grade 3–5 AEs | 15 (44) | 14 (30) | 26 (52) | 14 (37) | 22 (69) |
| Grade 3–5 TRAE | 6 (18)a | 2 (4) | 22 (44) | 8 (21) | 19 (59) |
| Serious AE | 9 (27) | 7 (15) | 4 (8) | 8 (21) | 11 (34) |
| Serious TRAE | 4 (12) | 0 (0) | 1 (2) | 5 (13) | 7 (22) |
| Discontinuation due to AE | 2 (6) | 0 (0) | 3 (6) | 3 (8) | 9 (28) |
| Discontinuation due to TRAE | 2 (6) | 0 (0) | 3 (6) | 2 (5) | 9 (28) |
| Death | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
AE adverse event, TRAE treatment-related adverse event
aNo grade 5 TRAEs occurred