Study: NCT02176031

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Intraparenchymal hemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hepatic failure
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Stenotrophomonas bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Klebsiella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Cytomegalovirus viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 21 at risk

Adverse event: C. diff colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Blood and lymphatic system disorders - other
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 21 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 21 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Large intestine infection
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 21 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Gastrointestinal disorders - other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 21 at risk

Adverse event: Impaired gastric emptying
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Localised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: no
Organ System: General disorders
Frequency: 2 affected / 21 at risk

Adverse event: Hepatobiliary disorders - other
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Portal hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 21 at risk

Adverse event: Infections and infestations - other
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 21 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 21 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 21 at risk

Adverse event: Investigations - other
Serious: no
Organ System: Investigations
Frequency: 1 affected / 21 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 21 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 21 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Musculoskeletal and connective tissue disorder - other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Trismus
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Encephalopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Nervous system disorders - other
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 21 at risk

Adverse event: Oedema genital
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 21 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 21 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 21 at risk