Table 7 Summary of GI AEs across age groups with incidence of ≥ 2.5% in any erenumab group by preferred term (safety analysis set)
Aged < 40 years, n (%) | Placebo (n = 597) | Erenumab 70 mg (n = 514) | Erenumab 140 mg (n = 382) | Erenumab 70 + 140 mg (n = 896) | Total (N = 1493) |
Participants with GI TEAEs | 47 (7.9) | 48 (9.3) | 44 (11.5) | 92 (10.3) | 139 (9.3) |
 Constipation | 6 (1.0) | 16 (3.1) | 15 (3.9) | 31 (3.5) | 37 (2.5) |
Aged 40–49 years, n (%) | Placebo (n = 421) | Erenumab 70 mg (n = 356) | Erenumab 140 mg (n = 275) | Erenumab 70 + 140 mg (n = 631) | Total (N = 1052) |
Participants with GI TEAEs | 37 (8.8) | 26 (7.3) | 19 (6.9) | 45 (7.1) | 82 (7.8) |
 Constipation | 7 (1.7) | 8 (2.2) | 7 (2.5) | 15 (2.4) | 22 (2.1) |
Aged 50–59 years, n (%) | Placebo (n = 262) | Erenumab 70 mg (n = 214) | Erenumab 140 mg (n = 158) | Erenumab 70 + 140 mg (n = 372) | Total (N = 634) |
Participants with GI TEAEs | 25 (9.5) | 17 (7.9) | 15 (9.5) | 32 (8.6) | 57 (9.0) |
 Constipation | 3 (1.1) | 4 (1.9) | 7 (4.4) | 11 (3.0) | 14 (2.2) |
Aged ≥ 60 years, n (%) | Placebo (n = 69) | Erenumab 70 mg (n = 38) | Erenumab 140 mg (n = 35) | Erenumab 70 + 140 mg (n = 73) | Total (N = 142) |
Participants with GI TEAEs | 7 (10.1) | 3 (7.9) | 2 (5.7) | 5 (6.8) | 12 (8.5) |
 Constipation | 1 (1.4) | 0 | 1 (2.9) | 1 (1.4) | 2 (1.4) |
 Dyspepsia | 0 | 1 (2.6) | 0 | 1 (1.4) | 1 (0.7) |
 Nausea | 2 (2.9) | 1 (2.6) | 1 (2.9) | 2 (2.7) | 4 (2.8) |
 Toothache | 1 (1.4) | 1 (2.6) | 0 (0) | 1 (1.4) | 2 (1.4) |