Table 5 Incidence of treatment-emergent AEs by time period

Subjects at each time point, n

PBO/RIS

48

45

44

43

22

0

0

RIS/RIS

292

266

254

242

136

67

42

Direct-enroll

50

44

41

40

19

0

0

Any AE, n (%)

PBO/RIS

39 (81)

11 (24)

9 (20)

21 (49)

3 (14)

–

–

RIS/RIS

197 (67)

82 (31)

80 (31)

117 (48)

51 (38)

33 (49)

8 (19)

Direct-enroll

40 (80)

21 (48)

18 (44)

23 (58)

3 (16)

–

–

Somnolence, n (%)

PBO/RIS

15 (31)

1 (2)

2 (5)

1 (2)

0

–

–

RIS/RIS

55 (19)

4 (2)

8 (3)

9 (4)

2 (1)

3 (4)

0

Direct-enroll

16 (32)

4 (9)

2 (5)

2 (5)

0

–

–

Tremor, n (%)

PBO/RIS

6 (13)

0

0

0

0

–

–

RIS/RIS

23 (8)

2 (1)

3 (1)

5 (2)

2 (1)

0

0

Direct-enroll

3 (6)

1 (2)

0

0

0

–

–

Insomnia, n (%)

PBO/RIS

5 (10)

1 (2)

0

1 (2)

0

–

–

RIS/RIS

24 (8)

4 (2)

5 (2)

8 (3)

4 (3)

2 (3)

1 (2)

Direct-enroll

3 (6)

1 (2)

1 (2)

1 (3)

0

–

–

Hypertonia, n (%)

PBO/RIS

6 (13)

0

0

0

2 (9)

–

–

RIS/RIS

27 (9)

1 (<1)

6 (2)

7 (3)

0

0

0

Direct-enroll

6 (12)

1 (2)

0

2 (5)

0

–

–

Weight increase, n (%)

PBO/RIS

1 (2)

1 (2)

0

5 (12)

0

–

–

RIS/RIS

15 (5)

6 (2)

5 (2)

10 (4)

4 (3)

2 (3)

0

Direct-enroll

11 (22)

2 (5)

1 (2)

3 (8)

0

–

–