Study: NCT02507284

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 36 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Renal neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 36 at risk

Adverse event: Aggression and Irritability
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including gastrointestinal upset, vomiting, abdominal pain, dyspepsia
Frequency: 7 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: including urinary tract infection
Frequency: 6 affected / 36 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: including ankle fracture, contusion
Frequency: 4 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: including lethargy, dizziness, paraesthesia
Frequency: 6 affected / 36 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: including insomnia, irritability
Frequency: 8 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including gastrointestinal upset, vomiting, abdominal pain, dyspepsia
Frequency: 9 affected / 34 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: including urinary tract infection
Frequency: 4 affected / 34 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: including ankle fracture, contusion
Frequency: 4 affected / 34 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 34 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: including lethargy, dizziness, paraesthesia
Frequency: 4 affected / 34 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: including insomnia, irritability
Frequency: 8 affected / 34 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Including gastrointestinal upset, vomiting, abdominal pain, dyspepsia
Frequency: 4 affected / 36 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 36 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: including urinary tract infection
Frequency: 9 affected / 36 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: including ankle fracture, contusion
Frequency: 5 affected / 36 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: including lethargy, dizziness, paraesthesia
Frequency: 8 affected / 36 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: including insomnia, irritability
Frequency: 4 affected / 36 at risk