Table 3 Neuromotor developmental milestones (ITTE population)
Characteristics | Visit | Statistics | ‘sapropterin continuous’ (n = 25) | ‘sapropterin extension’ (n = 26) |
|---|---|---|---|---|
Area of assessment fine motor skills, n (%) | Baseline | Normal | 16 (69.6) | 24 (92.3) |
Abnormal | 7 (30.4) | 2 (7.7) | ||
Month 12 | Normal | 16 (69.6) | 22 (91.7) | |
Abnormal | 7 (30.4) | 2 (8.3) | ||
Month 24 | Normal | 16 (94.1) | 16 (88.9) | |
Abnormal | 1 (5.9) | 2 (11.1) | ||
EOS | Normal | 11 (84.6) | 14 (100.0) | |
Abnormal | 2 (15.4) | 0 | ||
Area of assessment gross motor skills, n (%) | Baseline | Normal | 21 (91.3) | 19 (73.1) |
Abnormal | 2 (8.7) | 7 (26.9) | ||
Month 12 | Normal | 21 (91.3) | 22 (91.7) | |
Abnormal | 2 (8.7) | 2 (8.3) | ||
Month 24 | Normal | 14 (82.4) | 15 (83.3) | |
Abnormal | 3 (17.6) | 3 (16.7) | ||
EOS | Normal | 12 (92.3) | 14 (100.0) | |
Abnormal | 1 (7.7) | 0 | ||
Area of assessment language, n (%) | Baseline | Normal | 20 (87.0) | 22 (84.6) |
Abnormal | 3 (13.0) | 4 (15.4) | ||
Month 12 | Normal | 18 (78.3) | 21 (87.5) | |
Abnormal | 5 (21.7) | 3 (12.5) | ||
Month 24 | Normal | 14 (82.4) | 14 (77.8) | |
Abnormal | 3 (17.6) | 4 (22.2) | ||
EOS | Normal | 12 (92.3) | 11 (78.6) | |
Abnormal | 1 (7.7) | 3 (21.4) | ||
Area of assessment personal-social, n (%) | Baseline | Normal | 20 (87.0) | 20 (76.9) |
Abnormal | 3 (13.0) | 6 (23.1) | ||
Month 12 | Normal | 21 (91.3) | 19 (79.2) | |
Abnormal | 2 (8.7) | 5 (20.8) | ||
Month 24 | Normal | 16 (94.1) | 14 (77.8) | |
Abnormal | 1 (5.9) | 4 (22.2) | ||
EOS | Normal | 13 (100.0) | 14 (100.0) | |
Abnormal | 0 | 0 |