Study: NCT02388776

Adverse event: Respiratory failure; grade 4
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Contusion/pneumonia; grade 3
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: SIRS; grade 3
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Anuria; grade 4
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Metabolic acidosis; grade 4
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hemachromaturia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 2 at risk

Adverse event: Massive anasarca
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 2 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Protein calorie malnutrition
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abnormal lab value/low hemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abnormal lab value/low hematocrit
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abnormal lab value/high INR
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Hypermetabolism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk

Adverse event: Abnormal lab value/hemoglobin dropped from 8.2 to 7
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: MSSA and Klebsiella
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2 at risk

Adverse event: Abnormal lab value/high sodium and uptrending creatinine
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 2 at risk

Adverse event: Thermal keratopathy, right eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Bilateral upper and lower eyelid swelling
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 2 at risk

Adverse event: Red blood per rectum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Pleural fluid
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 2 at risk