‘sapropterin continuous’ (n = 25) | ‘sapropterin extension’ (n = 26) | Overall (N = 51) | ||||
---|---|---|---|---|---|---|
Patients n (%) | Events n (%) | Patients n (%) | Events n (%) | Patients n (%) | Events n (%) | |
TEAEs | 25 (100) | 838 (100) | 24 (92.3) | 563 (100) | 49 (96.1) | 1401 (100) |
AEs related to sapropterin | 9 (36.0) | 40 (4.8) | 4 (15.4) | 7 (1.2) | 13 (25.5) | 47 (3.4) |
SAE | 6 (24.0) | 12 (1.4) | 7 (26.9) | 7 (1.2) | 13 (25.5) | 19 (1.4) |