Table 3.
Overall safety for both trial periods combined (safety analysis set)
| Group A (N=34) |
Group B (N=53) |
Group C (N=43) |
|
| Any TEAEs | 33 (97.1) | 51 (96.2) | 37 (86.0) |
| TEAEs leading to death | – | 2 (3.8) | – |
| Serious TEAEs | 15 (44.1) | 18 (34.0) | 12 (27.9) |
| Grade 3–5 TEAEs | 22 (64.7) | 32 (60.4) | 24 (55.8) |
| TEAEs of special interest | – | 2 (3.8) | – |
| DCVAC/OvCa-related TEAEs | 2 (5.9) | 2 (3.8) | – |
| TEAEs leading to discontinuation of DCVAC/OvCa | – | 1 (1.9) | – |
| Leukapheresis-related AEs | 5 (14.7) | 3 (5.7) | – |
| CT-related TEAEs | 29 (85.3) | 50 (94.3) | 35 (81.4) |
| TEAEs leading to discontinuation of CT | 1 (2.9) | 1 (1.9) | 1 (2.3) |
Values are n (%)
CT, chemotherapy; Group A, DCVAC/OvCa in parallel with CT; Group B, CT and sequential DCVAC/OvCa; Group C, CT only; TEAE, treatment-emergent adverse event.