Study: NCT00299702

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 179 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 179 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 179 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 179 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 179 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 179 at risk

Adverse event: Akathisia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 179 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 179 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 179 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 179 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 179 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 179 at risk

Adverse event: Depression suicidal
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 179 at risk

Adverse event: Affect lability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 179 at risk

Adverse event: Homicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 179 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 179 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 179 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 179 at risk

Adverse event: Hyperprolactinaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 179 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 179 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 179 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 179 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 179 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 179 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 179 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 179 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 179 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 179 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 9 affected / 179 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 179 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 179 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 179 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 179 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 179 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 179 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 179 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 179 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 39 affected / 179 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 179 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 179 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 179 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 179 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 179 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 179 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 47 affected / 179 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 179 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 32 affected / 179 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 179 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 179 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 179 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 179 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 179 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pancytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 176 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 176 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 176 at risk

Adverse event: Leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 176 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 176 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 11 affected / 176 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 12 affected / 176 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Alcoholism
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 176 at risk

Adverse event: Cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 176 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 176 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 176 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 176 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 176 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 176 at risk

Adverse event: Salivary hypersecretion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 176 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 176 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 17 affected / 176 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 14 affected / 176 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 176 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 176 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 176 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 176 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 15 affected / 176 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 176 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 176 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 176 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 176 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 176 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 27 affected / 176 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 176 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 176 at risk

Adverse event: Hypersomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 176 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 176 at risk

Adverse event: Sedation
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 176 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 51 affected / 176 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 30 affected / 176 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 26 affected / 176 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 176 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 176 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 176 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 176 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 176 at risk