Table 3 Summary of treatment-emergent adverse events from both studies, n (%)

Any AE

56 (53.8)

42 (54.5)

62 (57.9)

38 (52.1)

47 (62.7)

167 (47.9)

Possibly related^a

20 (19.2)

16 (20.8)

27 (25.2)

14 (19.2)

24 (32.0)

66 (18.9)

Discontinued due to AE

4 (3.8)

5 (6.5)

7 (6.5)

2 (2.7)

9 (12.0)

13 (3.7)

Severe AE

2 (1.9)

3 (3.9)

2 (1.9)

1 (1.4)

3 (4.0)

18 (5.2)

Serious AE

5 (4.8)

6 (7.8)

7 (6.5)

2 (2.7)

3 (4.0)

17 (4.9)

Deaths^b

0

0

0

0

2 (2.7)^c

4 (1.1)^d

AEs reported by ≥ 5.0 % of subjects in any treatment group in the double-blind study (MedDRA preferred term)

Constipation^e

3 (2.9)

7 (9.1)

16 (15.0)^e

3 (4.1)

2 (2.7)

17 (4.9)

Headache

7 (6.7)

5 (6.5)

4 (3.7)

5 (6.8)

8 (10.7)

11 (3.2)

Fall

4 (3.8)

4 (5.2)

5 (4.7)

3 (4.1)

5 (6.7)

15 (4.3)

Nausea

3 (2.9)

1 (1.3)

4 (3.7)

2 (2.7)

6 (8.0)

7 (2.0)

Diarrhea

2 (1.9)

2 (2.6)

4 (3.7)

2 (2.7)

4 (5.3)

6 (1.7)

Anxiety

1 (1.0)

1 (1.3)

7 (6.5)

2 (2.7)

0

6 (1.7)

Depressed mood

1 (1.0)

1 (1.3)

0

0

4 (5.3)

3 (0.9)