Table 2.
Safety summary post-randomization (safety evaluation set)
| AEs, n (%) | Switching (n = 118) | Continuous (n = 120) | Total (n = 238) |
|---|---|---|---|
| At least one TEAE | 67 (56.8) | 75 (62.5) | 142 (59.7) |
| At least one TEAEa | 14 (11.9) | 22 (18.3) | 36 (15.1) |
| At least one serious TEAE | 5 (4.2) | 4 (3.3) | 9 (3.8) |
| At least one non-serious TEAE | 67 (56.8) | 72 (60.0) | 139 (58.4) |
| At least one serious TEAEa | 0 (0.0) | 1 (0.8) | 1 (0.4) |
| At least one severe TEAE | 3 (2.5) | 5 (4.2) | 8 (3.4) |
| At least one TEAE of special interestb | 1 (0.8) | 0 (0.0) | 1 (0.4) |
| TEAEs leading to discontinuation | 1 (0.8) | 2 (1.7) | 3 (1.3) |
AEs adverse events, TEAE treatment-emergent adverse event
All patients who received at least one dose of study treatment in the randomized phase
aInvestigator assessed
bDefined as hepatic injury, anaphylactic reactions, serious infection, or hypersensitivity reactions