Table 6.
Summary of cardiovascular and cerebrovascular AEs by age groups (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) |
| Participants with CV/ cerebrovascular TEAEs | 12 (2.0) | 7 (1.4) | 10 (2.6) | 17 (1.9) | 29 (2.0) |
| Palpitations | 2 (0.3) | 2 (0.4) | 3 (0.8) | 5 (0.6) | 7 (0.5) |
| Hypertension | 2 (0.3) | 3 (0.6) | 0 | 3 (0.3) | 5 (0.3) |
| Hot flush | 2 (0.3) | 0 | 2 (0.5) | 2 (0.2) | 4 (0.3) |
| Flushing | 1 (0.2) | 0 | 1 (0.3) | 1 (0.1) | 2 (0.1) |
| Bundle branch block right | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Cardiac flutter | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Diastolic hypertension | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Haematoma | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Hypotension | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Junctional ectopic tachycardia | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
| Orthostatic hypotension | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Sinus tachycardia | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Supraventricular extrasystoles | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| Tachycardia | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Tricuspid valve incompetence | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Ventricular extrasystoles | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
| 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 CV/ cerebrovascular TEAEs | 10 (2.4) | 5 (1.4) | 7 (2.5) | 12 (1.9) | 22 (2.1) |
| Hypertension | 2 (0.5) | 2 (0.6) | 1 (0.4) | 3 (0.5) | 5 (0.5) |
| Palpitations | 2 (0.5) | 1 (0.3) | 2 (0.7) | 3 (0.5) | 5 (0.5) |
| Extrasystoles | 1 (0.2) | 0 | 1 (0.4) | 1 (0.2) | 2 (0.2) |
| Hot flush | 2 (0.5) | 0 | 0 | 0 | 2 (0.2) |
| Arrhythmia | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Capillary fragility | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Deep vein thrombosis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Haematoma | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Hypertensive crisis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
| Hypotension | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| Supraventricular tachycardia | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
| Thrombosis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
| 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 CV/ cerebrovascular TEAEs | 7 (2.7) | 4 (1.9) | 4 (2.5) | 8 (2.2) | 1 (0.2) |
| Hot flush | 1 (0.4) | 1 (0.5) | 2 (1.3) | 3 (0.8) | 5 (0.8) |
| Flushing | 0 | 1 (0.5) | 0 | 1 (0.3) | 4 (0.6) |
| Hypertension | 4 (1.5) | 1 (0.5) | 0 | 1 (0.3) | 2 (0.3) |
| Atrioventricular block first degree | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
| Palpitations | 1 (0.4) | 0 | 1 (0.6) | 1 (0.3) | 1 (0.2) |
| Peripheral coldness | 0 | 0 | 1 (0.6) | 1 (0.3) | 1 (0.2) |
| 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 CV/ cerebrovascular TEAEs | 4 (5.8) | 2 (5.3) | 0 | 2 (2.7) | 6 (4.2) |
| Hot flush | 1 (1.4) | 1 (2.6) | 0 | 1 (1.4) | 2 (1.4) |
| Flushing | 1 (1.4) | 0 | 0 | 0 | 1 (0.7) |
| Hypertensive crisis | 0 | 1 (2.6) | 0 | 1 (1.4) | 1 (0.7) |
| Tachycardia | 1 (1.4) | 0 | 0 | 0 | 1 (0.7) |
| Ventricular extrasystoles | 1 (1.4) | 0 | 0 | 0 | 1 (0.7) |
Data pooled from phase 2 CM, STRIVE, ARISE, LIBERTY, and EMPOwER studies (safety analysis set). The table contains AEs with onset date within 91 days from the first administration of erenumab. % = n/N × 100
The table contains AEs with onset date within 91 days from the first administration of the study drug. AEs are presented at the dose level at which the event occurred, so individuals who received erenumab at more than 1 dose level during the study were counted in both dose levels. Therefore, the total erenumab column may not be the sum of the individuals included in each of the individual dose levels
Abbreviations: AE Adverse event, CM Chronic migraine, CV Cardiovascular, N Number of individuals exposed to the given dose level, n number of individuals reporting at least 1 occurrence of an AE in that class within 91 days from the first administration, SAE Serious AE, TEAE Treatment-emergent AE