Table 1.
Incidence of chest pain and number of chest pain events during the TEAE period by treatment group and overall
| Alirocumab (n = 9451) | Placebo (n = 9443) | Overall (N = 18,894) | Unadjusted relative risk alirocumab vs placebo | |
|---|---|---|---|---|
| Combineda | ||||
| Total number of events (patients with events, n) | 1439 (1055) | 1554 (1176) | 2993 (2231) | |
| Risk (95 % CI) | 0.112 (0.105–0.118) | 0.125 (0.118–0.131) | 0.118 (0.114–0.123) | 0.896 |
| Non-hospitalized chest pain events as AE | ||||
| Total number of events (patients with events, n) | 892 (710) | 949 (780) | 1841 (1490) | |
| Risk (95 % CI) | 0.075 (0.070–0.080) | 0.083 (0.077–0.088) | 0.079 (0.075–0.083) | 0.910 |
| Hospitalized chest pain events negatively adjudicated for unstable angina or myocardial infarction | ||||
| Total number of events (patients with events, n) | 547 (449) | 605 (503) | 1152 (952) | |
| Risk (95 % CI) | 0.048 (0.043–0.052) | 0.053 (0.049–0.058) | 0.050 (0.047–0.054) | 0.892 |
a
Combined: Non-hospitalized chest pain events as AE or hospitalized chest pain events negatively adjudicated for unstable angina or myocardial infarction.
AE, adverse events; CI, confidence interval; TEAE, treatment-emergent adverse event.