Study: NCT02863926

Adverse event: Wound dehiscence at amputation site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fascial disruption or dehiscence without evisceration; primary wound closure or revision by operative intervention indicated
Frequency: 2 affected / 5 at risk

Adverse event: Glucose tolerance impaired
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Diabetic ketoacidosis
Frequency: 1 affected / 5 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Peripheral ischemia, non-index leg
Serious: yes
Organ System: Vascular disorders
Notes: Recurrent or prolonged ischemia in the non-treated lower extremity
Frequency: 1 affected / 5 at risk

Adverse event: Wound infection, non-index leg
Serious: yes
Organ System: Infections and infestations
Notes: Presence of wound/ulcer in the non-treated lower extremity
Frequency: 1 affected / 5 at risk

Adverse event: Major amputation, non-index leg
Serious: yes
Organ System: Vascular disorders
Notes: Amputation below the knee of non-treated lower extremity
Frequency: 1 affected / 5 at risk

Adverse event: Seroma at amputation site, index leg
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Seroma formation at surgical site after below knee amputation
Frequency: 1 affected / 5 at risk

Adverse event: Pain at amputation site
Serious: no
Organ System: General disorders
Notes: Pain experienced at the surgical amputation site
Frequency: 4 affected / 5 at risk

Adverse event: Wound developed on non-index foot
Serious: no
Organ System: Vascular disorders
Notes: Wounds, ulcers occurring on the non-treated lower extremity
Frequency: 1 affected / 5 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 5 at risk

Adverse event: Iliac crest pain, post bone marrow aspiration
Serious: no
Organ System: Investigations
Frequency: 1 affected / 5 at risk

Adverse event: Depression, worsening
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1 at risk

Adverse event: Chronic kidney disease with acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: CKD Stage III
Frequency: 1 affected / 1 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1 at risk

Adverse event: Chronic anemia, worsening
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1 at risk

Adverse event: Wound, non-index extremity
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Wound development to non-treated lower extremity
Frequency: 1 affected / 1 at risk

Adverse event: Chronic hypertension, worsening
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1 at risk

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

Adverse event: Depression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1 at risk

Adverse event: Skin integrity worsening, amputation site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1 at risk