Study: NCT02717195

Adverse event: Acute psychosis
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 708 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 708 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 708 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 708 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 708 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 708 at risk

Adverse event: Social stay hospitalisation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 708 at risk

Adverse event: Psychosocial support
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 708 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 708 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 708 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 34 affected / 708 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 708 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 384 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 384 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 384 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 384 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 384 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 384 at risk

Adverse event: Social stay hospitalisation
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 384 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 384 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 384 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 384 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 384 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 234 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 234 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Vascular stent thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 234 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 234 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 234 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 234 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 235 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 235 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 235 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 235 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 232 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 232 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 232 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 232 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 19 affected / 232 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 232 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 232 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 232 at risk

Adverse event: Intentional overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 230 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 230 at risk

Adverse event: Schizophrenia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 230 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 230 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 230 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 230 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 230 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 230 at risk

Adverse event: Akathisia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 230 at risk