Study: NCT02866682

Adverse event: Re-hospitalization
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 39 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 39 at risk

Adverse event: Important medical event requiring medical intervention
Serious: yes
Organ System: General disorders
Notes: The patient had an important medical event that, based upon the investigator's medical judgment, may significantly jeopardize the patient's health and require medical or surgical intervention to prevent negative outcomes
Frequency: 1 affected / 39 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 39 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 39 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 39 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 39 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 39 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 39 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 39 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 39 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 39 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 39 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hypomagnesimia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 39 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 39 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 39 at risk

Adverse event: Impaired Fasting Blood Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 39 at risk

Adverse event: Incisional Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 39 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 39 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Immune system disorders
Frequency: 7 affected / 39 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 12 affected / 39 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 39 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 12 affected / 39 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 39 at risk

Adverse event: Pyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 39 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 39 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 39 at risk

Adverse event: Tremor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 39 at risk

Adverse event: Abnormal Urinalysis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 39 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 39 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: de novo DSA
Serious: no
Organ System: Immune system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 39 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 39 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Secondary Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 39 at risk

Adverse event: Uncontrolled Diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 39 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 39 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Life threatening event associated with an immediate risk of death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 132 at risk

Adverse event: Re-hospitalization
Serious: yes
Organ System: General disorders
Frequency: 41 affected / 132 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 132 at risk

Adverse event: Important medical event requiring medical intervention
Serious: yes
Organ System: General disorders
Notes: The patient had an important medical event that, based upon the investigator's medical judgment, may significantly jeopardize the patient's health and require medical or surgical intervention to prevent negative outcomes
Frequency: 1 affected / 132 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 132 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 30 affected / 132 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 33 affected / 132 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 132 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 132 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 132 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 132 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 20 affected / 132 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 132 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 41 affected / 132 at risk

Adverse event: Hyperphosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 132 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 132 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 132 at risk

Adverse event: Hypomagnesimia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 59 affected / 132 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 51 affected / 132 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 132 at risk

Adverse event: Impaired Fasting Blood Glucose
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 132 at risk

Adverse event: Incisional Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 132 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 132 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Immune system disorders
Frequency: 15 affected / 132 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 41 affected / 132 at risk

Adverse event: Lower extremity edema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 132 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 29 affected / 132 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 132 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Immune system disorders
Frequency: 6 affected / 132 at risk

Adverse event: Post Operative Pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 19 affected / 132 at risk

Adverse event: Pyuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 132 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 132 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 27 affected / 132 at risk

Adverse event: Tremor
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 132 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 132 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 132 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 132 at risk

Adverse event: de novo DSA
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 132 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 132 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 132 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 132 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 132 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 132 at risk

Adverse event: Kidney transplant rejection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 132 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 132 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 132 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 132 at risk

Adverse event: Uncontrolled Diabetes
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 132 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 5 affected / 132 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Frequency: 7 affected / 132 at risk