Summary of treatment-emergent AEs in the DBTP and OLEP (open-label analysis set)
| Event | DBTP | OLEP | ||
| Erenumab 140 mg N=118, n (%)/e(r) | Placebo N=122, n (%)/e(r) | 1 year | 1-year+2 years | |
| Overall population N=240, n (%)/e(r) | Overall population N=240, n (%)/e(r) | |||
| Any AE | 70 (59.3)/17.4(402.6) | 68 (55.7)/18.0(377.9) | 194 (80.8)/79.9(242.9) | 207 (86.3)/104.6(198.0) |
| Any SAE | 2 (1.7)/27.9(7.2) | 1 (0.8)/29.1(3.4) | 16 (6.7)/222.7(7.2) | 25 (10.4)/398.4(6.3) |
| Any AE leading to discontinuation of treatment | 1 (0.8)/27.9(3.6) | 0 (0)/29.3(0) | 4 (1.7)/229.3(1.7) | 9 (3.8)/422.9(2.1) |
| Any treatment-related AE | 21 (17.8)/24.2(86.7) | 24 (19.7)/25.2(95.1) | 57 (23.8)/189.3(30.1) | 66 (27.5)/334.2(19.8) |
| Most frequently reported treatment-emergent AEs (per 100 patient-years) during the DBTP and OLEP, by preferred term | ||||
| Nasopharyngitis | 6 (5.1)/26.9(22.3) | 12 (9.8)/27.7(43.3) | 74 (30.8)/178.6(41.4) | 99 (41.3)/291.6(33.9) |
| Influenza | – | – | 31 (12.9)/212.6(14.6) | 39 (16.3)/379.6(10.3) |
| Back pain | 5 (4.2)/27.2(18.4) | 2 (1.6)/28.9(6.9) | 18 (7.5)/219.5(8.2) | 26 (10.8)/393.6(6.6) |
| Sinusitis | 1 (0.8)/27.9(3.6) | 1 (0.8)/29.1(3.4) | 10 (4.2)/224.0(4.5) | 20 (8.3)/405.6(4.9) |
| Migraine | 1 (0.8)/27.9(3.6) | 2 (1.6)/28.9(6.9) | 10 (4.2)/224.8(4.4) | 19 (7.9)/405.1(4.7) |
| Urinary tract infection | 0 (0)/28.1(0) | 1 (0.8)/29.1(3.4) | 10 (4.2)/225.9(4.4) | 18 (7.5)/405.9(4.4) |
| Gastroenteritis | 1 (0.8)/27.9(3.6) | 0 (0)/29.3(0) | 11 (4.6)/222.9(4.9) | 16 (6.7)/408.3(3.9) |
| Oropharyngeal pain | 1 (0.8)/27.8(3.6) | 0 (0)/29.3(0) | 6 (2.5)/227.4(2.6) | 16 (6.7)/410.9(3.9) |
| Arthralgia | 1 (0.8)/28.0(3.6) | 4 (3.3)/28.6(14.0) | 8 (3.3)/225.5(3.5) | 15 (6.3)/411.0(3.7) |
| Bronchitis | 2 (1.7)/27.8(7.2) | 1 (0.8)/29.1(3.4) | 11 (4.6)/223.7(4.9) | 15 (6.3)/406.4(3.7) |
| Injection site pain | 7 (5.9)/27.0(26.0) | 7 (5.7)/28.1(24.9) | 13 (5.4)/221.5(5.9) | 14 (5.8)/403.7(3.5) |
| Fatigue | 3 (2.5)/27.4(10.9) | 2 (1.6)/28.8(6.9) | 12 (5.0)/223.0(5.4) | 14 (5.8)/406.4(3.4) |
| Hypertension | 1 (0.8)/28.0(3.6) | 1 (0.8)/29.3(3.4) | 7 (2.9)/225.3(3.1) | 14 (5.8)/410.6(3.4) |
| Constipation | 1 (0.8)/27.9(3.6) | 2 (1.6)/29.0(6.9) | 6 (2.5)/226.4(2.7) | 13 (5.4)/415.0(3.1) |
| Nausea | 3 (2.5)/27.6(10.9) | 2 (1.6)/29.0(6.9) | 7 (2.9)/226.5(3.1) | 13 (5.4)/414.1(3.1) |
| Dizziness | 3 (2.5)/27.7(10.8) | 2 (1.6)/28.9(6.9) | 12 (5.0)/222.0(5.4) | 12 (5.0)/404.7(3.0) |
| Cystitis | 1 (0.8)/27.9(3.6) | 2 (1.6)/28.9(6.9) | 11 (4.6)/224.6(4.9) | 12 (5.0)/410.0(2.9) |
| Upper respiratory tract infection | 4 (3.4)/27.6(14.5) | 0 (0)/29.3(0) | 9 (3.8)/224.2(4.0) | 12 (5.0)/408.5(2.9) |
Time at risk during the OLEP is the time from the start of OLEP to onset of the first event in the OLEP or the minimum (end of study date, data cut-off date, last investigational product dose+112). Data cut-off date: Week 116 or if participant discontinued prior Week 116 then minimum (end of study date, last patient last week 116) - Double-blind treatment (either erenumab 140 mg or placebo) was given at day 1, week 4 and week 8 visit then open label erenumab 140 mg was given during OLEP starting from week 12 visit. MedDRA V.22.1 was used for the reporting of AEs. The 1-year+2-year overall population data are cumulative of the data from DBTP, first and second year of OLEP. In the 'overall population' column, preferred terms are sorted by AE frequency in decreasing order.
e, sum across all participants, the total time at risk in the OLEP in years r, exposure-adjusted patient rate per 100 patient-years (n/e × 100).
AE, adverse event; DBTP, double-blind treatment phase; n, number of participants reporting at least one occurrence of an AE in that class; N, number of participants in the analysis set; OLEP, open-label extension phase; SAE, serious AE.