Table 6 Number of subjects having adverse events from total visits and the adverse events categorized by severity in the study and control groups

Subjects had adverse events, person

36 (31.0)

28 (23.3)

64 (27.12)

1.33 [0.87-2.03]

0.177^b

Actual adverse events, event

65 (100)

51 (100)

116 (100)

Serious adverse events

 Bloating

0 (0)

1 (1.96)

1 (0.86)

 Hepatitis

0 (0)

1 (1.96)

1 (0.86)

 Severe diarrhea

1 (1.54)

1 (1.96)

2 (1.72)

Non-serious adverse events

 Bloating

50 (76.92)

33 (64.72)

83 (71.56)

 Abdominal cramp

0 (0)

1 (1.96)

1 (0.86)

 Nausea

0 (0)

4 (7.84)

4 (3.45)

 Vomiting

1 (1.54)

1 (1.96)

2 (1.72)

 Increase defecation

2 (3.08)

0 (0)

2 (1.72)

 Diarrhea

4 (6.15)

4 (7.84)

8 (6.90)

 Constipation

2 (3.08)

2 (3.92)

4 (3.45)

 Other

5 (7.69)

3 (5.88)

8 (6.90)