Table 3 Summary of TEAEs during the LTE (safety population)a
LTE safety population (N = 33) | |
|---|---|
Participants with ≥1 AE, n (%) | 31 (93.9) |
Mild | 13 (39.4) |
Moderate | 17 (51.5) |
Severe | 1 (3.0) |
Participants with ≥1 treatment-related AE, n (%) | 14 (42.4) |
Mild | 5 (15.2) |
Moderate | 8 (24.2) |
Severe | 1 (3.0) |
Participants with ≥1 procedure-related AE, n (%) | 24 (72.7) |
Mild | 15 (45.5) |
Moderate | 9 (27.3) |
Severe | 0 |
Participants with ≥1 serious AE, n (%) | 4 (12.1) |
Participants with ≥1 treatment-related serious AE, n (%) | 0 |
Participants with ≥1 procedure-related serious AE, n (%) | 0 |
Participants with ≥1 AE leading to discontinuation of BIIB080, n (%) | 3 (9.1) |
