Table 2 Summary of adverse events
N (%) | Patient subgroup | |||||||
|---|---|---|---|---|---|---|---|---|
Prior preventive treatment failure | Concomitant preventive | |||||||
Yes (N = 117) | No (N = 144) | Yes (N = 92) | No (N = 169) | |||||
Erenumab 70 mg (N = 59) | Placebo (N = 58) | Erenumab 70 mg (N = 71) | Placebo (N = 73) | Erenumab 70 mg (N = 40) | Placebo (N = 52) | Erenumab 70 mg (N = 90) | Placebo (N = 79) | |
≥1 TEAE | 41 (69.5) | 35 (60.3) | 44 (62.0) | 42 (57.5) | 26 (65.0) | 28 (53.8) | 59 (65.6) | 49 (62.0) |
Grade ≥2 | 34 (57.6) | 28 (48.3) | 38 (53.5) | 38 (52.1) | 24 (60.0) | 24 (46.2) | 48 (53.3) | 42 (53.2) |
Grade ≥3 | 3 (5.1) | 1 (1.7) | 1 (1.4) | 1 (1.4) | 2 (5.0) | 0 (0.0) | 2 (2.2) | 2 (2.5) |
Grade ≥4 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3) |
Any SAE | 1 (1.7) | 1 (1.7) | 1 (1.4) | 1 (1.4) | 0 (0.0) | 0 (0.0) | 2 (2.2) | 2 (2.5) |
AE leading to discontinuation of investigational product | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Fatal AE | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |