Table 3.
Treatment-emergent adverse events by Child-Pugh class at start of therapy in the safety population
| Adverse events | Total (N = 331) |
Child-Pugh A (n = 246) |
Child-Pugh B (n = 48) |
Child-Pugh C (n = 2) |
Not evaluable (n = 35) |
|---|---|---|---|---|---|
| Treatment-emergent AE (all grades including deaths not documented as AE) | 233 (70) | 175 (71) | 38 (79) | 0 (0) | 20 (57) |
| AEs resulting in permanent discontinuation | 29 (8.8) | 22 (8.9) | 5 (10) | 0 (0) | 2 (5.7) |
| Treatment-emergent AE (all grades) | 167 (51) | 124 (50) | 27 (56) | 0 (0) | 16 (46) |
| Grade 3–4 | 20 (6.0) | 14 (5.7) | 4 (8.3) | 0 (0) | 20 (6.0) |
| Grade 5 | 73 (22) | 55 (22) | 11 (23) | 0 (0) | 7 (20) |
| Drug-related AE (all grades) | 95 (29) | 67 (27) | 17 (35) | 0 (0) | 11 (31) |
| Grade 3–4 | 12 (3.6) | 9 (3.7) | 2 (4.2) | 0 (0) | 1 (2.9) |
| Grade 5 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Serious AE (all grades) | 77 (23) | 58 (24) | 12 (25) | 0 (0) | 7 (20) |
| Drug-related (all grades) | 1 (0.3) | 0 (0) | 1 (2.1) | 0 (0) | 0 (0) |
| All deaths | 166 (50) | 127 (52) | 27 (56) | 0 (0) | 12 (34) |
| Treatment-emergent death | 73 (22) | 55 (22) | 11 (23) | 0 (0) | 7 (20) |
Data are presented as count (percentage). Percentages are presented to 2 significant figs
AE adverse event, SAE serious adverse event
Treatment-emergent deaths: death while on sorafenib and up to 30 days after last dose collected from all available sources
All deaths: all deaths from all sources where death information was collected including follow-up information