Table 4 Treatment-emergent SAEs across age groups, 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) |
Number of participants with at least one SAE | 7 (1.2) | 6 (1.2) | 2 (0.5) | 8 (0.9) | 15 (1.0) |
Asthenia | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
Cholelithiasis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
Hypersensitivity | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Gastroenteritis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
Labyrinthitis | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
Urinary tract infection | 0 | 1 (0.2) | 0 | 1 (0.1) | 1 (0.1) |
Gastrointestinal infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Parotitis | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Viral infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Cartilage injury | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
Flank pain | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Intervertebral disc protrusion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Syncope | 0 | 0 | 1 (0.3) | 1 (0.1) | 1 (0.1) |
Migraine | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Abortion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Ovarian cyst | 0 | 1 (0.2) | 0 | 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) |
Number of participants with at least one SAE | 8 (1.9) | 6 (1.7) | 5 (1.8) | 11 (1.7) | 19 (1.8) |
Abdominal adhesions | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Abdominal pain | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Vomiting | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Cholelithiasis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
Cholecystitis | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Cholecystitis acute | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Hypersensitivity | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Appendicitis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
Clostridium difficile colitis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Kidney infection | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Pyelonephritis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Sepsis | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Urinary tract infection | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Ankle fracture | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Post-traumatic neck syndrome | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
Traumatic fracture | 0 | 0 | 1 (0.4) | 1 (0.2) | 1 (0.1) |
Fall | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Costochondritis | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
Intervertebral disc protrusion | 0 | 1 (0.3) | 0 | 1 (0.2) | 1 (0.1) |
Migraine | 0 | 1 (0.3) | 1 (0.4) | 2 (0.3) | 2 (0.2) |
Abortion | 1 (0.2) | 0 | 0 | 0 | 1 (0.1) |
Endometriosis | 1 (0.2) | 0 | 0 | 0 | 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) |
Number of participants with at least one SAE | 3 (1.1) | 4 (1.9) | 2 (1.3) | 6 (1.6) | 9 (1.4) |
Pancreatitis | 1 (0.4) | 0 | 0 | 0 | 1 (0.2) |
Non-cardiac chest pain | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
Vestibular neuronitis | 0 | 0 | 1 (0.6) | 1 (0.3) | 1 (0.2) |
Hyponatraemia | 1 (0.4) | 0 | 0 | 0 | 1 (0.2) |
Back pain | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
Intervertebral disc protrusion | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
Fibroma | 0 | 1 (0.5) | 0 | 1 (0.3) | 1 (0.2) |
Uterine leiomyoma | 1 (0.4) | 0 | 1 (0.6) | 1 (0.3) | 2 (0.3) |
Migraine | 1 (0.4) | 0 | 0 | 0 | 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) |
Number of participants with at least one SAE | 0 | 0 | 0 | 0 | 0 |