Study: NCT00401726

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 269 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 269 at risk

Adverse event: Cholecystits
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 269 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 269 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 269 at risk

Adverse event: Neurosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 269 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 269 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 269 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 269 at risk

Adverse event: Unintended pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 269 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 269 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 30 affected / 269 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 17 affected / 269 at risk

Adverse event: Cardiovascular general
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 269 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 269 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 269 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 269 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 269 at risk

Adverse event: Metabolic and nutritional general
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 269 at risk

Adverse event: Musculoskeletal general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 269 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 269 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 269 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 269 at risk

Adverse event: Respiratory general
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 269 at risk

Adverse event: Skin and appendages general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 269 at risk

Adverse event: Special senses general
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 269 at risk

Adverse event: Urogenital general
Serious: no
Organ System: Renal and urinary disorders
Frequency: 28 affected / 269 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 268 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 268 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 268 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 268 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 268 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Non-specific Drug Reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Overdose
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Self-injurious ideation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 268 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 268 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 268 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 268 at risk

Adverse event: Thinking abnormal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 268 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 268 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 268 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 20 affected / 268 at risk

Adverse event: Infection
Serious: no
Organ System: General disorders
Frequency: 12 affected / 268 at risk

Adverse event: Cardiovascular general
Serious: no
Organ System: Cardiac disorders
Frequency: 27 affected / 268 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 268 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 268 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 268 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 268 at risk

Adverse event: Metabolic and nutritional general
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 268 at risk

Adverse event: Musculoskeletal general
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 268 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 268 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 268 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 268 at risk

Adverse event: Respiratory general
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 268 at risk

Adverse event: Skin and appendages general
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 268 at risk

Adverse event: Special senses general
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 268 at risk

Adverse event: Urogenital general
Serious: no
Organ System: Renal and urinary disorders
Frequency: 25 affected / 268 at risk