|
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
|
- EOS end of extension period (month 36), ITTE intention-to-treat extension (population)
