Table 1.

Cataract-related treatment-emergent adverse events in the safety population

	Placebo (N = 9443)	Alirocumab (N = 9451)
Any cataract-related treatment-emergent adverse event
N, % (95% CI)	134, 1.4% (1.2, 1.7)	127, 1.3% (1.1, 1.5)
Event rate per 100 patient-years (95% CI)a	0.5 (0.5, 0.6)	0.5 (0.4, 0.6)
Hazard ratio versus placebo (95% CI)b		0.93 (0.73, 1.20)
Subcategories of cataract-related treatment-emergent adverse events, N (%)
Cataract	127 (1.3%)	116 (1.2%)
Atopic cataract	0	1 (< 0.1%)
Cataract cortical	2 (< 0.1%)	1 (< 0.1%)
Cataract nuclear	3 (< 0.1%)	1 (< 0.1%)
Cataract subcapsular	0	1 (< 0.1%)
Lenticular opacities	1 (< 0.1%)	1 (< 0.1%)
Cataract diabetic	1 (< 0.1%)	0

CI Confidence interval

^a Calculated as number of patients with an event divided by total patient years. For patients with event, number of patient years is calculated up to date of the first event, for patients without event, it corresponds to the length of the treatment-emergent adverse event period

^b Calculated using a Cox model