Study: NCT01475214

Adverse event: Contusions/abrasions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Resulting from falls
Frequency: 1 affected / 84 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Bloating, dizziness
Frequency: 1 affected / 84 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: High serum potassium
Serious: no
Organ System: Renal and urinary disorders
Notes: Potassium level \> 5.3 meq/L
Frequency: 5 affected / 84 at risk

Adverse event: low GFR
Serious: no
Organ System: Renal and urinary disorders
Notes: Reported if GFR \< 55; protocol change GFR \< 45
Frequency: 4 affected / 84 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset, heartburn, gas, bloating, nausea
Frequency: 5 affected / 84 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache, migraine
Frequency: 1 affected / 84 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 84 at risk

Adverse event: Knee/hip injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Sprain
Frequency: 1 affected / 84 at risk

Adverse event: Constipation/diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 84 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 84 at risk

Adverse event: High serum potassium
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Contusions/abrasions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Resulting from falls
Frequency: 1 affected / 79 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Fracture, right wrist, from fall
Frequency: 1 affected / 79 at risk

Adverse event: High serum potassium
Serious: no
Organ System: Renal and urinary disorders
Notes: Potassium level \> 5.3 meq/L
Frequency: 8 affected / 79 at risk

Adverse event: low GFR
Serious: no
Organ System: Renal and urinary disorders
Notes: Reported if GFR \< 55; protocol change GFR \< 45
Frequency: 3 affected / 79 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset, heartburn, gas, bloating, nausea
Frequency: 9 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache, migraine
Frequency: 1 affected / 79 at risk

Adverse event: Heart palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Knee/hip injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Sprain
Frequency: 2 affected / 79 at risk

Adverse event: Constipation/diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reports numbness in thumb
Frequency: 1 affected / 79 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Abdominal aortic repair
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: High serum potassium
Serious: no
Organ System: Renal and urinary disorders
Notes: Potassium level \> 5.3 meq/L
Frequency: 5 affected / 81 at risk

Adverse event: low GFR
Serious: no
Organ System: Renal and urinary disorders
Notes: Reported if GFR \< 55; protocol change GFR \< 45
Frequency: 3 affected / 81 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI upset, heartburn, gas, bloating, nausea
Frequency: 6 affected / 81 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Headache, migraine
Frequency: 2 affected / 81 at risk

Adverse event: Heart palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 81 at risk

Adverse event: Fever, fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 81 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 81 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 81 at risk

Adverse event: Stomatitis
Serious: no
Organ System: General disorders
Notes: Roof of mouth irritation
Frequency: 1 affected / 81 at risk

Adverse event: Constipation/diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 81 at risk