Study: NCT02008721

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hepatotoxicity leading to discontinuation of study
Frequency: 2 affected / 47 at risk

Adverse event: Pneumonia due to aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 47 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: synkope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 47 at risk

Adverse event: gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 47 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 47 at risk

Adverse event: fracture of femoral bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 47 at risk

Adverse event: phlegmone hand
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 47 at risk

Adverse event: heatstroke and exsikkosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 47 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 47 at risk

Adverse event: urinary dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 47 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 47 at risk

Adverse event: falls
Serious: no
Organ System: Nervous system disorders
Notes: due to postural instability, ataxia or orthostatic hypotension
Frequency: 17 affected / 47 at risk

Adverse event: worsening of parkinsonism, ataxia or autonomic dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 47 at risk

Adverse event: Hepatotoxicity
Serious: no
Organ System: Hepatobiliary disorders
Notes: increased aminotransferase concentrations
Frequency: 6 affected / 47 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: gastrointestinal adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea, stomach pain, gastritis, constipation
Frequency: 17 affected / 47 at risk

Adverse event: swallowing problems
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 47 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: leg edema
Frequency: 3 affected / 47 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 5 affected / 47 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 45 at risk

Adverse event: synkope
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 45 at risk

Adverse event: gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 45 at risk

Adverse event: fracture of femoral bone
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 45 at risk

Adverse event: general worsening of overall health
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 45 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 12 affected / 45 at risk

Adverse event: urinary dysfunction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 45 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 45 at risk

Adverse event: falls
Serious: no
Organ System: Nervous system disorders
Notes: due to postural instability, ataxia or orthostatic hypotension
Frequency: 17 affected / 45 at risk

Adverse event: worsening of parkinsonism, ataxia or autonomic dysfunction
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 45 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 45 at risk

Adverse event: gastrointestinal adverse event
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea, stomach pain, gastritis, constipation
Frequency: 13 affected / 45 at risk

Adverse event: Oedema
Serious: no
Organ System: Vascular disorders
Notes: leg edema
Frequency: 3 affected / 45 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 45 at risk