Study: NCT02360319

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Psychiatric hospitalization/illness
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening of psychosis or other psychiatric condition
Frequency: 96 affected / 255 at risk

Adverse event: Jail
Serious: yes
Organ System: Social circumstances
Frequency: 2 affected / 255 at risk

Adverse event: Serious psychiatric event not requiring hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 255 at risk

Adverse event: Confusional state
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 255 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 255 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 255 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 255 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 255 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 47 affected / 241 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 241 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 241 at risk

Adverse event: Hyperprolactemia
Serious: no
Organ System: Endocrine disorders
Frequency: 31 affected / 241 at risk

Adverse event: Elevated cholesterol levels
Serious: no
Organ System: Cardiac disorders
Frequency: 24 affected / 241 at risk

Adverse event: Hepatic enzyme abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 22 affected / 241 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 241 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 18 affected / 241 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 11 affected / 241 at risk

Adverse event: Hostility/aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 241 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 241 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 241 at risk

Adverse event: Psychiatric hospitalization/illness
Serious: yes
Organ System: Psychiatric disorders
Notes: Worsening of psychosis or other psychiatric condition
Frequency: 60 affected / 234 at risk

Adverse event: Serious psychiatric event not requiring hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 234 at risk

Adverse event: Abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 234 at risk

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

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 234 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Lactation
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 234 at risk

Adverse event: Asthma Exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 234 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 234 at risk

Adverse event: Overdose
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 234 at risk

Adverse event: Chest laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 234 at risk

Adverse event: Weight increased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 222 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 222 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 222 at risk

Adverse event: Hyperprolactemia
Serious: no
Organ System: Endocrine disorders
Frequency: 9 affected / 222 at risk

Adverse event: Elevated cholesterol levels
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 222 at risk

Adverse event: Hepatic enzyme abnormalities
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 222 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 19 affected / 222 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 222 at risk

Adverse event: Somnolence
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 222 at risk

Adverse event: Hostility/aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 222 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 222 at risk

Adverse event: Restlessness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 222 at risk