Study: NCT03249909

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: In-patient hospitalization following syncopal episode
Frequency: 1 affected / 78 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: In-patient hospitalization for right arm fistula
Frequency: 1 affected / 78 at risk

Adverse event: Revisional transmetatarsal amputation right foot
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: In-patient hospitalization for transmetatarsal amputation on right foot with full thickness wound along surgical site.
Frequency: 1 affected / 78 at risk

Adverse event: Infection on non-study foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: In-patient hospitalization for infection on non-study foot
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In-patient hospitalization for pneumonia
Frequency: 1 affected / 78 at risk

Adverse event: Kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: In-patient hospitalization for kidney injury
Frequency: 1 affected / 78 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: In-patient hospitalization for shortness of breath
Frequency: 1 affected / 78 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: In-patient hospitalization for cellulitis of the lower limb
Frequency: 1 affected / 78 at risk

Adverse event: Inability to eat
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: In-patient hospitalization for inability to eat
Frequency: 1 affected / 78 at risk

Adverse event: Cellulitis of non-study wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Notes: Cold, or flu-like symptoms
Frequency: 1 affected / 78 at risk

Adverse event: Exacerbation of congestive heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 78 at risk

Adverse event: Infection of the study wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 78 at risk

Adverse event: Itching of the non-study wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Maceration in study wound
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 78 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: New ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pain in study wound
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Pain not related to study wound
Serious: no
Organ System: General disorders
Frequency: 2 affected / 78 at risk

Adverse event: Peripheral artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cellulitis of non-study wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Cellulitis of study wound
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk

Adverse event: Infection of the study wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Infection on non-study foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: In-patient hospitalization for infection on non-study foot
Frequency: 1 affected / 16 at risk

Adverse event: Exacerbation of congestive heart failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 16 at risk

Adverse event: Infection of the study wound
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk