| Hypertension (SMQ)a | Embolic and Thrombotic events (SMQ)a | Ischemic heart disease (SMQ)a | |||||
---|---|---|---|---|---|---|---|---|
Dose Group | Age Group (years) | N | n/TPY | EAIR (95% CI) | n/TPY | EAIR (95% CI) | n/TPY | EAIR (95% CI) |
Double-blind treatment phase | ||||||||
Phase 3_Pooled Placebo | < 42 42 to < 50 50 to < 60 60 to ≤ 65 | 687 359 309 96 | 6/248.3 7/134.9 3/112.8 2/33.5 | 2.4 (0.9, 5.3) 5.2 (2.1, 10.7) 2.7 (0.6, 7.8) 6.0 (0.7, 21.6) | 1/249.2 0/136.2 1/113.2 2/33.8 | 0.4 (0.0, 2.2) 0.0 (NA, 2.7) 0.9 (0.0, 4.9) 5.9 (0.7, 21.4) | 0/249.3 0/136.2 0/113.3 1/33.9 | 0.0 (NA, 1.5) 0.0 (NA, 2.7) 0.0 (NA, 3.3) 3.0 (0.1, 16.4) |
Phase 3_Pooled GMB | < 42 42 to < 50 50 to < 60 60 to ≤ 65 | 742 322 300 71 | 5/273.7 2/122.5 7/110.8 2/26.0 | 1.8 (0.6, 4.3) 1.6 (0.2, 5.9) 6.3 (2.5, 13.0) 7.7 (0.9, 27.8) | 1/274.0 1/122.8 2/112.3 0/26.6 | 0.4 (0.0, 2.0) 0.8 (0.0, 4.5) 1.8 (0.2, 6.4) 0.0 (NA, 13.9) | 0/274.1 1/123.0 1/112.4 0/26.6 | 0.0 (NA, 1.4) 0.8 (0.0, 4.5) 0.9 (0.0, 5.0) 0.0 (NA, 13.9) |
All GMB exposure | ||||||||
All GMB Exposure | < 42 42 to < 50 50 to < 60 60 to ≤ 65 | 1295 599 538 154 | 13/713.6 7/360.1 14/311.7 5/89.5 | 1.8 (1.0, 3.1) 1.9 (0.8, 4.0) 4.5 (2.5, 7.5) 5.6 (1.8, 13.0) | 2/717.6 1/362.1 3/314.8 0/91.4 | 0.3 (0.0, 1.0) 0.3 (0.0, 1.5) 1.0 (0.2, 2.8) 0.0 (NA, 4.0) | 0/718.4 1/361.6 2/314.8 0/91.4 | 0.0 (NA, 0.5) 0.3 (0.0, 1.5) 0.6 (0.1, 2.3) 0.0 (NA, 4.0) |