Table VI.
Overview of TEAEs, both overall and according to background statin therapy* (safety population) n (%)
| Parameter | High-intensity statin (n = 580) | Low/moderate-intensity statin (n = 181) | No statin (n = 233) | All (n = 994) |
|---|---|---|---|---|
| Any TEAE | 378 (65.2) | 136 (75.1) | 198 (85.0) | 712 (71.6) |
| Treatment-emergent SAEs | 85 (14.7) | 21 (11.6) | 55 (23.6) | 161 (16.2) |
| TEAEs leading to death | 1 (0.2) | 1 (0.6) | 0 | 2 (0.2) |
| TEAEs leading to permanent treatment discontinuation | 16 (2.8) | 8 (4.4) | 21 (9.0) | 45 (4.5) |
*
High-intensity statin was defined as atorvastatin 40 or 80 mg, rosuvastatin 20 or 40 mg, or simvastatin 80 mg daily; low/moderate-intensity statin was defined as all other statins and/or doses.
SAE – serious adverse event, TEAE – treatment-emergent adverse event.