Figure 3.

Fixed effects meta-analysis of the safety population: (A) major adverse cardiovascular event, fatal and non-fatal myocardial infarction and fatal and non-fatal stroke (pooled data from ORION-9, ORION-10 and ORION-11), and (B) major adverse cardiovascular event by individual study. *Inclisiran, n = 1833; ^†Placebo, n = 1822. The meta-analysis used the Peto method¹⁶ for pooling studies to ensure that patients enrolled in ORION-9 were included in the analysis, although there were no reported stroke events in the ORION-9 trial. The model used for the meta-analysis included study as a fixed effect. The major adverse cardiovascular event count included treatment emergent adverse events and non- treatment emergent adverse events. Fatal and non-fatal stroke counts included only serious adverse events. Definitions of major adverse cardiovascular event, fatal and non-fatal myocardial infarction, and fatal and non-fatal stroke are provided in the Supplementary material online, Table S2. Test of heterogeneity and I²for major adverse cardiovascular event or adverse cardiovascular event, Q = 0.48 P = 0.79; I² = 0.00%.