Study: NCT01639872

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychosis
Frequency: 3 affected / 23 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Abdominal pain
Frequency: 1 affected / 23 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Dyspnea
Frequency: 1 affected / 23 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Tachycardia
Frequency: 2 affected / 23 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 23 at risk

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

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

Adverse event: other-Sialorrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: other-Sialorrhea
Frequency: 10 affected / 23 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: hypercholesterolemia
Frequency: 2 affected / 23 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hyperglycemia
Frequency: 2 affected / 23 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypertriglyceridemia
Frequency: 3 affected / 23 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: weight gain
Frequency: 7 affected / 23 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain
Frequency: 1 affected / 23 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Cough
Frequency: 3 affected / 23 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Dizziness
Frequency: 4 affected / 23 at risk

Adverse event: Extrpyramidal Effects
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal Effects
Frequency: 1 affected / 23 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 2 affected / 23 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 23 at risk

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Notes: Sedation
Frequency: 5 affected / 23 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: Suicidal Ideation
Frequency: 2 affected / 23 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Tremor
Frequency: 1 affected / 23 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Psychosis
Frequency: 1 affected / 24 at risk

Adverse event: other-rhabdomyolisis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Suicidal ideation
Frequency: 2 affected / 24 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Leukopenia
Frequency: 2 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 1 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 24 at risk

Adverse event: other-Sialorrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: other-Sialorrhea
Frequency: 2 affected / 24 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Hypertriglyceridemia
Frequency: 1 affected / 24 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Increased appetite
Frequency: 3 affected / 24 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: weight gain
Frequency: 3 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back pain
Frequency: 2 affected / 24 at risk

Adverse event: Extrpyramidal Effects
Serious: no
Organ System: Nervous system disorders
Notes: Extrapyramidal Effects
Frequency: 2 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 2 affected / 24 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk

Adverse event: Sedation
Serious: no
Organ System: Psychiatric disorders
Notes: Sedation
Frequency: 4 affected / 24 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Notes: Suicidal Ideation
Frequency: 1 affected / 24 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: Tremor
Frequency: 2 affected / 24 at risk