Table 5.
Treatment-emergent AEs in US patients enrolled in GIDEON by TACE group
| n (%) | No TACE n=318 | Group A Prior TACE n=158 | Group B Concomitant TACE n=29 | Group C Prior and Concomitant TACE n=38 |
|---|---|---|---|---|
| AEs (all grades) | 311 (98) | 156 (99) | 29 (100) | 38 (100) |
| Grade 3 | 85 (27) | 60 (38) | 11 (38) | 12 (32) |
| Grade 4 | 21 (7) | 11 (7) | 1 (3) | 2 (5) |
| Serious AEs (all grades) | 198 (62) | 72 (46) | 18 (62) | 17 (45) |
| Drug-related AEs (all grades) | 215 (68) | 121 (77) | 22 (76) | 30 (79) |
| Grade 3 | 61 (19) | 44 (28) | 5 (17) | 6 (16) |
| Grade 4 | 9 (3) | 3 (2) | 0 | 0 |
| AEs resulting in permanent discontinuation of sorafenib | 116 (37) | 64 (41) | 7 (24) | 8 (21) |
| Deatha | 131 (41) | 41 (26) | 9 (31) | 6 (16) |
Data refer to the safety population (n=563).
a
Death while on treatment and up to 30 days of last dose collected from all available sources.