Study: NCT00946309

Adverse event: Burping (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1: Symptomatic but not interfering with activities of daily living daily living
Frequency: 4 affected / 21 at risk

Adverse event: Burping (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2: Symptomatic and interfering with activities of
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal Bloating (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1: No change in bowel function or oral intake
Frequency: 5 affected / 21 at risk

Adverse event: Abdominal bloating (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2: Symptomatic decreased oral intake; change in bowel function
Frequency: 1 affected / 21 at risk

Adverse event: Heartburn (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Vomiting (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal Pain (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 21 at risk

Adverse event: Abdominal Pain (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Flatulence (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 21 at risk

Adverse event: Flatulence (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: Diarrhea (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Constipation (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Constipation (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Light Headed (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache (Grade 1)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Burping (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1: Symptomatic but not interfering with activities of daily living daily living
Frequency: 6 affected / 23 at risk

Adverse event: Abdominal Bloating (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 1: No change in bowel function or oral intake
Frequency: 3 affected / 23 at risk

Adverse event: Heartburn (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Heartburn (grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Vomiting (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Vomiting (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

Adverse event: Abdominal Pain (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Abdominal Pain (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Flatulence (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Flatulence (Grade 2)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Diarrhea (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 23 at risk

Adverse event: Constipation (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Change in Stool Consistency (Grade 1)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Increase in Appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

Adverse event: Hyperglycemia (Grade 3)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk