Study: NCT01412060

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 19 affected / 765 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 765 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 765 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 765 at risk

Adverse event: Social stay hospitalisation
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 765 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 765 at risk

Adverse event: Drug abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 765 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 765 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 765 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 765 at risk

Adverse event: Insomnia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 765 at risk

Adverse event: Intentional product misuse
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 765 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 765 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 765 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 765 at risk

Adverse event: Psychiatric evaluation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 765 at risk

Adverse event: Psychotic behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 765 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 765 at risk

Adverse event: Restlessness
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 765 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 765 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 765 at risk

Adverse event: Victim of crime
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 765 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 765 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 765 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 48 affected / 765 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 49 affected / 765 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 148 affected / 765 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 55 affected / 765 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 92 affected / 765 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 39 affected / 765 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 110 affected / 765 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Frequency: 70 affected / 765 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 7 affected / 99 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 99 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 99 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 99 at risk

Adverse event: Middle ear effusion
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 99 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 99 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 99 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 99 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 101 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 101 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 101 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Drug ineffective
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Extrapyramidal disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 101 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 101 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 101 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Schizophrenia
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 101 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 765 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 765 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 765 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 99 at risk