Study: NCT00790868

Adverse event: Pancreatitis
Serious: yes
Organ System: Endocrine disorders
Notes: One participant was hospitalized for pancreatitis and released the following morning. Follow-up care included additional testing to determine best course of action. This event was judged to be unrelated to the study procedures.
Frequency: 1 affected / 88 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 88 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 88 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 4 affected / 88 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 88 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 88 at risk

Adverse event: Jitteriness/tremor
Serious: no
Organ System: General disorders
Frequency: 3 affected / 88 at risk

Adverse event: Agitation/restlessness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 88 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 88 at risk

Adverse event: Anxiety/panic
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 88 at risk

Adverse event: Impaired concentration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 88 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 88 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 88 at risk

Adverse event: Paresthesias
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 88 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 88 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Derealisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 88 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Endocrine disorders
Notes: One participant was hospitalized for the treatment of appendicitis. At the time, the participant was in the active phase of the study. This event was judged to be unrelated to study procedures.
Frequency: 1 affected / 92 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Gastrointestinal distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 92 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 92 at risk

Adverse event: Sedation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 92 at risk

Adverse event: Jitteriness/tremor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Dizziness/lightheadedness
Serious: no
Organ System: General disorders
Frequency: 10 affected / 92 at risk

Adverse event: Impaired concentration
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 92 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 92 at risk

Adverse event: Paresthesias
Serious: no
Organ System: General disorders
Frequency: 4 affected / 92 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 92 at risk

Adverse event: Derealisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 92 at risk

Adverse event: Menstruation irregular
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 92 at risk