Table 3 Most frequently reported subject-reported outcomes* of GI events (all-treated set)

Flatulence

 0 (no event)

13 (33)

12 (31)

 1 (mild)

8 (20)

13 (33)

 2 (moderate)

11 (28)

6 (15)

 3 (severe)

3 (8)

6 (15)

 4 (very severe)

4 (10)

2 (5)

Bloating

 0 (no event)

17 (43)

14 (36)

 1 (mild)

9 (23)

10 (26)

 2 (moderate)

5 (13)

11 (28)

 3 (severe)

7 (18)

4 (10)

 4 (very severe)

1 (3)

0 (0)

Diarrhea

 0 (no event)

25 (63)

22 (56)

 1 (mild)

7 (18)

7 (18)

 2 (moderate)

4 (10)

6 (15)

 3 (severe)

3 (8)

3 (8)

 4 (very severe)

0 (0)

1 (3)