Study: NCT02626156

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

Adverse event: Heart attack or failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: New ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: New ulcers that developed on the treatment and non-treatment leg not involving the study healed ulcer
Frequency: 10 affected / 42 at risk

Adverse event: Recurrent ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Recurrent ulcers of study wound
Frequency: 6 affected / 42 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash or redness of study leg or foot
Frequency: 1 affected / 42 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Injuries from falls or other trauma
Frequency: 2 affected / 42 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 40 at risk

Adverse event: New ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: New ulcers that developed on the treatment and non-treatment leg not involving the study healed ulcer
Frequency: 5 affected / 40 at risk

Adverse event: Recurrent ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Recurrent ulcers of study wound
Frequency: 3 affected / 40 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Injuries from falls or other trauma
Frequency: 1 affected / 40 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 29 at risk

Adverse event: Heart attack or failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 29 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 29 at risk

Adverse event: New ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: New ulcers that developed on the treatment and non-treatment leg not involving the study healed ulcer
Frequency: 3 affected / 29 at risk

Adverse event: Recurrent ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Recurrent ulcers of study wound
Frequency: 11 affected / 29 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgeries included cataracts, orthopedic
Frequency: 3 affected / 29 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: Knee infection after surgery
Frequency: 1 affected / 29 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 29 at risk

Adverse event: Fainted
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 29 at risk

Adverse event: Amputation
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 29 at risk

Adverse event: New ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: New ulcers that developed on the treatment and non-treatment leg not involving the study healed ulcer
Frequency: 4 affected / 29 at risk

Adverse event: Recurrent ulcers
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Recurrent ulcers of study wound
Frequency: 5 affected / 29 at risk

Adverse event: Surgery
Serious: no
Organ System: Surgical and medical procedures
Notes: Surgeries included cataracts, orthopedic
Frequency: 2 affected / 29 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Injuries from falls or other trauma
Frequency: 2 affected / 29 at risk