Study: NCT01128192

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 10 subjects (53.6%) in the 600 µg sc bid arm. 10 subjects (53.6%) in the 900 µg sc bid arm. 5 subjects (71.4%) in the 1200 µg sc bid arm.
Frequency: 10 affected / 19 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 subjects (31.6%) in the 600 µg sc bid arm. 9 subjects (47.4%) in the 900 µg sc bid arm. 4 subjects (57.1%) in the 1200 µg sc bid arm.
Frequency: 6 affected / 19 at risk

Adverse event: Loose Stools (soft stools)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 subjects (26.3%) in the 600 µg sc bid arm. 13 subjects (68.4%) in the 900 µg sc bid arm. 2 subjects (28.6%) in the 1200 µg sc bid arm.
Frequency: 5 affected / 19 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 4 subjects (21.1%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 4 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects (15.8%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.

1 subjects (14.3%) in the 1200 µg sc bid arm.
Frequency: 3 affected / 19 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 3 subjects (15.8%) in the 600 µg sc bid arm.

1 subject (14.3%) in the 1200 µg sc bid arm.
Frequency: 3 affected / 19 at risk

Adverse event: Vomiting/emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. 3 subjects (42.8%) in the 1200 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Gas (Flatulence)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Upper respiratory infection (common cold)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Frequent Stools
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Tooth impacted
Serious: no
Organ System: General disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Light colored stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Pressure in gut
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 10 subjects (53.6%) in the 600 µg sc bid arm. 10 subjects (53.6%) in the 900 µg sc bid arm. 5 subjects (71.4%) in the 1200 µg sc bid arm.
Frequency: 10 affected / 19 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 subjects (31.6%) in the 600 µg sc bid arm. 9 subjects (47.4%) in the 900 µg sc bid arm. 4 subjects (57.1%) in the 1200 µg sc bid arm.
Frequency: 9 affected / 19 at risk

Adverse event: Loose Stools (soft stools)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 subjects (26.3%) in the 600 µg sc bid arm. 13 subjects (68.4%) in the 900 µg sc bid arm. 2 subjects (28.6%) in the 1200 µg sc bid arm.
Frequency: 13 affected / 19 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Gastrointestinal disorders
Notes: 4 subjects (21.1%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects (15.8%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.

1 subjects (14.3%) in the 1200 µg sc bid arm.
Frequency: 4 affected / 19 at risk

Adverse event: Vomiting/emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. 3 subjects (42.8%) in the 1200 µg sc bid arm.
Frequency: 3 affected / 19 at risk

Adverse event: Gas (Flatulence)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.
Frequency: 4 affected / 19 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Upper respiratory infection (common cold)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 subject (5.3%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm.
Frequency: 3 affected / 19 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: 1 subject (5.3%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Injection site bruise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 1 subject (5.3%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: 1 subject (5.3%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Vasovagal reaction while voiding
Serious: no
Organ System: General disorders
Notes: 2 subjects (10.5%) in the 900 µg sc bid arm.
Frequency: 2 affected / 19 at risk

Adverse event: Infiltration, left ACFf
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Procedural complication:

1 subject (5.3%) in the 900 µg sc bid arm.
Frequency: 1 affected / 19 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 10 subjects (53.6%) in the 600 µg sc bid arm. 10 subjects (53.6%) in the 900 µg sc bid arm. 5 subjects (71.4%) in the 1200 µg sc bid arm.
Frequency: 5 affected / 7 at risk

Adverse event: Abdominal Cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: 6 subjects (31.6%) in the 600 µg sc bid arm. 9 subjects (47.4%) in the 900 µg sc bid arm. 4 subjects (57.1%) in the 1200 µg sc bid arm.
Frequency: 4 affected / 7 at risk

Adverse event: Loose Stools (soft stools)
Serious: no
Organ System: Gastrointestinal disorders
Notes: 5 subjects (26.3%) in the 600 µg sc bid arm. 13 subjects (68.4%) in the 900 µg sc bid arm. 2 subjects (28.6%) in the 1200 µg sc bid arm.
Frequency: 2 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 3 subjects (15.8%) in the 600 µg sc bid arm. 4 subjects (21.1%) in the 900 µg sc bid arm.

1 subjects (14.3%) in the 1200 µg sc bid arm.
Frequency: 1 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 3 subjects (15.8%) in the 600 µg sc bid arm.

1 subject (14.3%) in the 1200 µg sc bid arm.
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting/emesis
Serious: no
Organ System: Gastrointestinal disorders
Notes: 2 subjects (10.5%) in the 600 µg sc bid arm. 3 subjects (15.8%) in the 900 µg sc bid arm. 3 subjects (42.8%) in the 1200 µg sc bid arm.
Frequency: 3 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Notes: 1 subject (14.3%) in the 1200 µg sc bid arm.
Frequency: 1 affected / 7 at risk

Adverse event: Histamine-like reaction
Serious: no
Organ System: General disorders
Notes: 1 subject (14.3%) in the 1200 µg sc bid arm.
Frequency: 1 affected / 7 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: 1 subject (14.3%) in the 1200 µg sc bid arm.
Frequency: 1 affected / 7 at risk