Adverse event, n (%)

Control group (n = 132)

Itopride group (n = 64)

p-value

At least one adverse event Discontinued due to adverse events Common adverse events^a

Nausea Diarrhea Abdominal pain Vomiting Chest pain Dyspepsia Dyspnea Flatulence Dizziness

54 (40.9)

37 (26.5)

30 (22.7)

21 (15.9)

6 (4.5)

3 (2.3)

2 (1.5)

2 (1.5)

2 (1.5)

1 (0.8)

1 (0.8)

14 (21.9)

4 (6.3)

6 (9.4)

4 (6.3)

2 (3.1)

0 (0.0)

1 (1.6)

1 (1.6)

1 (1.6)

1 (1.6)

1 (1.6)

0.008

<0.001 0.039 0.094 0.931 0.552 0.552 0.552 0.552 0.817 0.817