Study: NCT00618839

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Notes: Poor graft healing found approximately 48 days following autograft placement. This event was judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: The bilateral pulmonary embolism was judged unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Joint effusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: The right knee effusion was judged unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Notes: There was no difference in infection between StrataGraft and cadaver skin. 1 subject was visually infected at both sites and 2 subjects had laboratory evidence of infection at both sites. Infection was judged unrelated to StrataGraft skin tissue.
Frequency: 9 affected / 15 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: All adverse events (AE) were judged unrelated to treatment with StrataGraft skin tissue.
Frequency: 8 affected / 15 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 8 affected / 15 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 6 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 7 affected / 15 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 8 affected / 15 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Albumin globulin ratio decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Aphonia
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Aspartate aminotransferase decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Blood albumin decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Blood bilirubin decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Carbon dioxide decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood chloride decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood chloride increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blood creatinine decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood culture positive
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blood lactate dehydrogenase increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood magnesium increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: BLOOD PHOSPHOROUS ELEVATED
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood phosphorus increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood potassium decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood potassium increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Blood urea decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Blood urea increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Culture positive
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Ectropion
Serious: no
Organ System: Eye disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: ELEVATED PHOSPHOROUS
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Eschar
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Extraskeletal ossification
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Globulins increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Haematocrit decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: High density lipoprotein decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hyperaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Hypertrophic scar
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 5 affected / 15 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Impaired healing
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Limb discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Livedo reticularis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Mean platelet volume decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Microstomia
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Monocyte count increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Neutrophil count increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: PCO2 decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Peroneal nerve palsy
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Platelet count increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 8 affected / 15 at risk

Adverse event: Platelet morphology abnormal
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 5 affected / 15 at risk

Adverse event: Poor peripheral circulation
Serious: no
Organ System: Vascular disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Prothrombin time prolonged
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Anal pruritus
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Purulent discharge
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Radial nerve palsy
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 4 affected / 15 at risk

Adverse event: Red blood cell count decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Red blood cells urine
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Red cell distribution width increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Restlessness
Serious: no
Organ System: Psychiatric disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Septic shock
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Transferrin decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Urine output decreased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: White blood cell count increased
Serious: no
Organ System: Investigations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 3 affected / 15 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Wound closure
Serious: no
Organ System: Surgical and medical procedures
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 1 affected / 15 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: All AE were judged to be unrelated to treatment with StrataGraft skin tissue.
Frequency: 2 affected / 15 at risk