Study: NCT00866918

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 2 affected / 66 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adeers submitted
Frequency: 6 affected / 66 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Adeers submitted
Frequency: 3 affected / 66 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 4 affected / 66 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 2 affected / 66 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Second primary malignancy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 66 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Agitation
Serious: no
Organ System: Psychiatric disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 14 affected / 66 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Anorectal infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 5 affected / 66 at risk

Adverse event: Arachnoiditis
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 8 affected / 66 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Blood and lymphatic system disorders - Other, specify
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 5 affected / 66 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pulmonary haemorrhage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 7 affected / 66 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Dysarthria
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 16 affected / 66 at risk

Adverse event: Enterocolitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Oesophageal infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 29 affected / 66 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 6 affected / 66 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 16 affected / 66 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 13 affected / 66 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 13 affected / 66 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 5 affected / 66 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 8 affected / 66 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 15 affected / 66 at risk

Adverse event: Laryngeal inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Laryngeal obstruction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Lipase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Lymph gland infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Metabolism and nutrition disorders - Other, specify
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 12 affected / 66 at risk

Adverse event: Nail infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 6 affected / 66 at risk

Adverse event: Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Nervous system disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Pain of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pancreatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Rash pustular
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Platelet count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Haemothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Pneumonitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Anal fistula
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Renal and urinary disorders - Other, specify
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders - Other, specify
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Differentiation syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 4 affected / 66 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Skin and subcutaneous tissue disorders - Other, specify
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 5 affected / 66 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Stoma site infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Surgical and medical procedures - Other, specify
Serious: no
Organ System: Surgical and medical procedures
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Tracheal stenosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Vitreous haemorrhage
Serious: no
Organ System: Eye disorders
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 6 affected / 66 at risk

Adverse event: Vulvitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 66 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 3 affected / 66 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 66 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 2 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 3 affected / 35 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Infections and infestations - Other, specify
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 3 affected / 35 at risk

Adverse event: International normalised ratio increased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Notes: Adeers submitted
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophil count decreased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Platelet count decreased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Adeers submitted
Frequency: 3 affected / 35 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: White blood cell count decreased
Serious: yes
Organ System: Investigations
Notes: Adeers submitted
Frequency: 1 affected / 35 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 4 affected / 35 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Activated partial thromboplastin time prolonged
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 7 affected / 35 at risk

Adverse event: Blood alkaline phosphatase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 5 affected / 35 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Appendicitis perforated
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Cardiac disorders - Other, specify
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 4 affected / 35 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Disseminated intravascular coagulation
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 6 affected / 35 at risk

Adverse event: Enterocolitis infectious
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Oesophageal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Oesophageal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Eye disorders - Other, specify
Serious: no
Organ System: Eye disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Adeers not subm
Frequency: 20 affected / 35 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Blood fibrinogen decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 4 affected / 35 at risk

Adverse event: Hepatic infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 4 affected / 35 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 9 affected / 35 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Hypophosphataemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 5 affected / 35 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Infections and infestations - Other, specify
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 15 affected / 35 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Haemorrhage intracranial
Serious: no
Organ System: Nervous system disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Investigations - Other, specify
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 6 affected / 35 at risk

Adverse event: Lymphocyte count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Mucosal infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 7 affected / 35 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Mouth haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Adeers not subm
Frequency: 8 affected / 35 at risk

Adverse event: Papilloedema
Serious: no
Organ System: Eye disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Proctalgia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Differentiation syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Enteritis infectious
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Adeers not subm
Frequency: 2 affected / 35 at risk

Adverse event: Splenic infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Suicide attempt
Serious: no
Organ System: Psychiatric disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Tumour lysis syndrome
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: Adeers not subm
Frequency: 3 affected / 35 at risk

Adverse event: Vascular access complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Adeers not subm
Frequency: 1 affected / 35 at risk