Study: NCT01867580

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 93 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 93 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Purulent discharge
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Wound infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 93 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 93 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 93 at risk

Adverse event: Post Porcedural Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 93 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 93 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 93 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 93 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 93 at risk

Adverse event: Blood Glucose Fluctation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 93 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 93 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 93 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 93 at risk

Adverse event: Skin maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 93 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 93 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 93 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 93 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 93 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 88 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 88 at risk

Adverse event: Wound infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Wound sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 88 at risk

Adverse event: Transplant failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 88 at risk

Adverse event: Wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 88 at risk

Adverse event: Wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 88 at risk

Adverse event: Device failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 88 at risk

Adverse event: Venous thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Wound haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 88 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Aggression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Drug dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Foot amputation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 88 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Skin graft failure
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 15 affected / 88 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 88 at risk

Adverse event: Skin maceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 88 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 88 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 88 at risk

Adverse event: Glycosylated haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 88 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 88 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 88 at risk