Study: NCT02339740

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Differentiation syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypohidrosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 101 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 101 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 101 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 101 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 101 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 101 at risk

Adverse event: Periorbital oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 101 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 101 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 101 at risk

Adverse event: Kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 101 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 101 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 16 affected / 101 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 11 affected / 101 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 67 affected / 101 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 101 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 101 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 101 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hyperuricaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 101 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 101 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Depressed level of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 101 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Peripheral sensory neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 101 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 101 at risk

Adverse event: Uterine haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 101 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 101 at risk

Adverse event: Laryngeal haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Differentiation syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Sinus pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 101 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 101 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 101 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Differentiation syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 57 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Anaphylactic reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 57 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 57 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 57 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 43 affected / 57 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 57 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 57 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 57 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 57 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 57 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Cognitive disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 57 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 57 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 57 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 57 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Differentiation syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Photosensitivity reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 57 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 57 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 57 at risk