Study: NCT01207388

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Bone marrow failure
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Leukopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 116 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 116 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 116 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 116 at risk

Adverse event: Device issue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 116 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Gait disturbance
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Infusion site extravasation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Product contamination microbial
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Puncture site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 17 affected / 116 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hepatotoxicity
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 116 at risk

Adverse event: Cytokine release syndrome
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Acinetobacter bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Bronchopulmonary aspergillosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Cystitis klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 116 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 116 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Urinary tract infection staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 116 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Incision site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Infusion related reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 116 at risk

Adverse event: Post lumbar puncture syndrome
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Subdural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 116 at risk

Adverse event: Alanine aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 116 at risk

Adverse event: Aspartate aminotransferase increased
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 116 at risk

Adverse event: Blood bilirubin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Body temperature increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: C-reactive protein increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 116 at risk

Adverse event: Hepatic enzyme increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Prothrombin time prolonged
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 116 at risk

Adverse event: Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 116 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 116 at risk

Adverse event: Aphasia
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Ataxia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Cognitive disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Dysarthria
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 116 at risk

Adverse event: Intention tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Leukoencephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Motor dysfunction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 116 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 116 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 116 at risk

Adverse event: Agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 116 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 116 at risk

Adverse event: Disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 116 at risk

Adverse event: Dermatitis contact
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Rash maculo-papular
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 116 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Vena cava thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 116 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 116 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 116 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 116 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 116 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 116 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 116 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 30 affected / 116 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 27 affected / 116 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 99 affected / 116 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 116 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 116 at risk

Adverse event: Blood immunoglobulin G decreased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 116 at risk

Adverse event: C-reactive protein increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 116 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 7 affected / 116 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 18 affected / 116 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 116 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 116 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 116 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 116 at risk

Adverse event: Aphasia
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 116 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 116 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 44 affected / 116 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 116 at risk

Adverse event: Tremor
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 116 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 17 affected / 116 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 116 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 116 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 116 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 116 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 116 at risk