Study: NCT02533934

Adverse event: Hospitalization (Unknown)
Serious: yes
Organ System: General disorders
Notes: Reported hospitalization with unknown etiology in retrospective study participant
Frequency: 3 affected / 42 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: infection AKI
Frequency: 1 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 42 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: esophagogastroduodendoscopy
Serious: yes
Organ System: Hepatobiliary disorders
Notes: due to cirrosis
Frequency: 2 affected / 42 at risk

Adverse event: Gout
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperglycaemic seizure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pruritus
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Neck femur fracture
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Polysubstance use
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 42 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperbilirubiinemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 42 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pnemonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Psychomotor hyperactivity
Serious: yes
Organ System: Nervous system disorders
Notes: abnormal movements, hyperactivity, etiology unknown
Frequency: 1 affected / 26 at risk

Adverse event: Ampullary stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Deep vein thrombosis
Frequency: 1 affected / 26 at risk

Adverse event: Gasteroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: scheduled hospitalization for followup surgery to remove polyps from colon
Frequency: 1 affected / 26 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: right upper extremity clot
Frequency: 1 affected / 26 at risk

Adverse event: Unresponsive with hypoactive delirium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 26 at risk