Study: NCT02158806

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Infection of ulceration
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Metastatic squamous cell carcinoma
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pneumonitis due to food and vomit
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Volvulus
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal haemorrhage, unspecified
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis of lower limb
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute kidney failure, unspecified
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Epistaxis
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain, unspecified
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Other and unspecified abdominal pain
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: General disorders
Notes: Malaise and fatigue
Frequency: 1 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Surgical and medical procedures
Notes: Presence of hip implant
Frequency: 1 affected / 125 at risk

Adverse event: Significan medical event
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm of breast, unspecified part
Frequency: 2 affected / 125 at risk

Adverse event: Death
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm of prostate
Frequency: 1 affected / 125 at risk

Adverse event: Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other unspecified respiratory disorder
Frequency: 1 affected / 125 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Other specified respiratory disorders
Frequency: 1 affected / 125 at risk

Adverse event: Bleeding from any lower leg ulceration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 125 at risk

Adverse event: Infection of ulceration, any lower leg ulceration
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Developed any new lower leg ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Extension of reference ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Including incorporation of other ulcers into reference ulcer
Frequency: 1 affected / 125 at risk

Adverse event: Coagulation defect, unspecified
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Longer bleeding time on small cuts to hands
Frequency: 1 affected / 125 at risk

Adverse event: Depressive episode, unspecified
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 125 at risk

Adverse event: Parophthalmia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastro-oesophageal reflux disease without oesophagi's
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastric ulcer, unspecified as acute or chronic, without haemorrhage or perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Gastritis, unspecified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 125 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Laceration and contusions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 125 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Staphylococcal infection, unspecified site
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Other cardiomyopathies
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Phlebitis and thrombophlebitis of other deep vessels of lower extremities
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Haemorrhage of anus and rectum
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal haemorrhage, unspecified
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis of lower limb
Frequency: 3 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Pharyngeal pouch
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Syncope and collapse
Frequency: 1 affected / 126 at risk

Adverse event: Hospitalisation or prolongation of hospitalisation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fracture shaft of tibia with fracture of fibula (any part)
Frequency: 1 affected / 126 at risk

Adverse event: Life threatening event of illness
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Malignant neoplasm of brain, unspecified
Frequency: 1 affected / 126 at risk

Adverse event: Significant medical event
Serious: yes
Organ System: Immune system disorders
Notes: Allergy, unspecified
Frequency: 1 affected / 126 at risk

Adverse event: Bleeding from any lower leg ulceration
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 126 at risk

Adverse event: Infection of ulceration, any lower leg ulceration
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 126 at risk

Adverse event: Developed any new lower leg ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 126 at risk

Adverse event: Extension of reference ulceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Including incorporation of other ulcers into reference ulcer
Frequency: 2 affected / 126 at risk

Adverse event: Candidal stomatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Varicophlebitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 126 at risk

Adverse event: Varicose veins of lower extremities without ulcer or inflammation
Serious: no
Organ System: Vascular disorders
Notes: Saphenous femoral junction incompetence, other leg
Frequency: 1 affected / 126 at risk

Adverse event: Gastritis, unspecified
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cellulitis of lower limb
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 126 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Tendency to fall, not elsewhere classified
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 126 at risk

Adverse event: Laceration and contusions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Allergy, unspecified
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 126 at risk