Table 3.
TEAEs with incidence of ≥ 3.0% in any erenumab group (safety analysis set), by preferred term
| 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) |
| Number of participants with at least one AE | 265 (44.4) | 227 (44.2) | 167 (43.7) | 394 (44.0) | 659 (44.1) |
| Upper respiratory tract infection | 19 (3.2) | 23 (4.5) | 15 (3.9) | 38 (4.2) | 57 (3.8) |
| Viral upper respiratory tract infection | 24 (4.0) | 23 (4.5) | 14 (3.7) | 37 (4.1) | 61 (4.1) |
| Constipation | 6 (1.0) | 16 (3.1) | 15 (3.9) | 31 (3.5) | 37 (2.5) |
| Injection-site pain | 10 (1.7) | 22 (4.3) | 9 (2.4) | 31 (3.5) | 41 (2.7) |
| 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) |
| Number of participants with at least one AE | 207 (49.2) | 150 (42.1) | 118 (42.9) | 268 (42.5) | 475 (45.2) |
| Viral upper respiratory tract infection | 23 (5.5) | 15 (4.2) | 8 (2.9) | 23 (3.6) | 46 (4.4) |
| Upper respiratory tract infection | 8 (1.9) | 12 (3.4) | 2 (0.7) | 14 (2.2) | 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) |
| Number of participants with at least one AE | 109 (41.6) | 93 (43.5) | 80 (50.6) | 173 (46.5) | 282 (44.5) |
| Viral upper respiratory tract infection | 11 (4.2) | 10 (4.7) | 10 (6.3) | 20 (5.4) | 31 (4.9) |
| Upper respiratory tract infection | 6 (2.3) | 9 (4.2) | 4 (2.5) | 13 (3.5) | 19 (3.0) |
| Constipation | 3 (1.1) | 4 (1.9) | 7 (4.4) | 11 (3.0) | 14 (2.2) |
| Injection-site pain | 2 (0.8) | 3 (1.4) | 5 (3.2) | 8 (2.2) | 10 (1.6) |
| Oropharyngeal pain | 3 (1.1) | 3 (1.4) | 5 (3.2) | 8 (2.2) | 11 (1.7) |
| Dizziness | 1 (0.4) | 0 | 5 (3.2) | 5 (1.3) | 6 (0.9) |
| 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) |
| Number of participants with at least one AE | 41 (59.4) | 15 (39.5) | 17 (48.6) | 32 (43.8) | 73 (51.4) |
| Fatigue | 2 (2.9) | 2 (5.3) | 2 (5.7) | 4 (5.5) | 6 (4.2) |
| Upper respiratory tract infection | 2 (2.9) | 3 (7.9) | 1 (2.9) | 4 (5.5) | 6 (4.2) |
| Alopecia | 0 | 0 | 2 (5.7) | 2 (2.7) | 2 (1.4) |
| Back pain | 0 | 0 | 2 (5.7) | 2 (2.7) | 2 (1.4) |
| Injection-site pain | 0 | 0 | 2 (5.7) | 2 (2.7) | 2 (1.4) |
| Ligament sprain | 0 | 2 (5.3) | 0 | 2 (2.7) | 2 (1.4) |
| Musculoskeletal stiffness | 0 | 2 (5.3) | 0 | 2 (2.7) | 2 (1.4) |
| Sinusitis | 2 (2.9) | 2 (5.3) | 0 | 2 (2.7) | 4 (2.8) |
| Viral upper respiratory tract infection | 4 (5.8) | 2 (5.3) | 0 | 2 (2.7) | 6 (4.2) |
Data pooled from the phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The summary shows TEAEs with onset day within the first 3 months (91 days) from the first administration of erenumab/placebo. Preferred terms are sorted in descending frequency of AEs in the 70/140 mg column and then alphabetically. A participant with multiple AEs is counted only once in the “at least one AE” row. A participant with multiple AEs with the same preferred term is counted only once for that preferred term
Abbreviations: AEs Adverse events, CM Chronic migraine, TEAE Treatment-emergent adverse event