Study: NCT02736955

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 35 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 35 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 35 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 117 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Paranoia
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 117 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 117 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 117 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 117 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 117 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 117 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 117 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 117 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 117 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 117 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 8 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk