Study: NCT02521181

Adverse event: Cardiovascular Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 52 at risk

Adverse event: Gastrointestinal Hospitalizations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 52 at risk

Adverse event: Renal Hospitalizations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Musculoskeletal Hospitalizations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 52 at risk

Adverse event: Psychiatric Hospitalizations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Severe gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms was severe
Frequency: 9 affected / 52 at risk

Adverse event: Moderate gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is moderate
Frequency: 7 affected / 52 at risk

Adverse event: Mild gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is mild
Frequency: 24 affected / 52 at risk

Adverse event: Reached ESRD (Dialysis or Transplant)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Cardiovascular Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 90 at risk

Adverse event: Gastrointestinal Hospitalizations
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 90 at risk

Adverse event: Infection Hospitalizations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 90 at risk

Adverse event: Renal Hospitalizations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 90 at risk

Adverse event: Malignancy Hospitalizations
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 90 at risk

Adverse event: Respiratory Hospitalizations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 90 at risk

Adverse event: Musculoskeletal Hospitalizations
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 90 at risk

Adverse event: Endocrine Disorder Hospitalizations
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 90 at risk

Adverse event: Vascular Hospitalizations
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 90 at risk

Adverse event: Severe gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms was severe
Frequency: 16 affected / 90 at risk

Adverse event: Moderate gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is moderate
Frequency: 22 affected / 90 at risk

Adverse event: Mild gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is mild
Frequency: 36 affected / 90 at risk

Adverse event: Cardiovascular Hospitalizations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 52 at risk

Adverse event: Infection Hospitalizations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Renal Hospitalizations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 52 at risk

Adverse event: Injury Hospitalizations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 52 at risk

Adverse event: Respiratory Hospitalizations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 52 at risk

Adverse event: Psychiatric Hospitalizations
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 52 at risk

Adverse event: Severe gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms was severe
Frequency: 5 affected / 52 at risk

Adverse event: Moderate gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is moderate
Frequency: 13 affected / 52 at risk

Adverse event: Mild gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Highest level of symptoms is mild
Frequency: 24 affected / 52 at risk