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. 2017 Nov 27;39(5):374–381. doi: 10.1093/eurheartj/ehx661

Table 1.

Severity of neurocognitive TEAEs

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.