Table 1.
Placebo-controlled pool |
Ezetimibe-controlled pool |
Pool of all studies |
||||
---|---|---|---|---|---|---|
Alirocumab (n = 2476) | Placebo (n = 1276) | Alirocumab (n = 864) | Ezetimibe (n = 618) | Alirocumab (n = 3340) | Control (n = 1894) | |
Any neurocognitive TEAE, n (%) | 22 (0.9) | 9 (0.7) | 10 (1.2) | 8 (0.9) | 32 (1.0) | 17 (0.9) |
Mild | 14 (63.6) | 4 (44.4) | 9 (90.0) | 4 (50.0) | 23 (0.7) | 8 (0.4) |
Moderate | 8 (36.4) | 4 (44.4) | 1 (10.0) | 4 (50.0) | 9 (0.3) | 8 (0.4) |
Severe | 0 | 1 (11.1) | 0 | 0 | 0 | 1 (0.1) |
Neurocognitive TEAEs categorized using the Sponsor CMQ.
CMQs, custom Medical Dictionary of Regulatory Activities queries; TEAEs, treatment-emergent adverse events.