Study: NCT00075803

Adverse event: Cardiovascular arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 295 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 295 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 295 at risk

Adverse event: Pulmoary embolus
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 295 at risk

Adverse event: troponin level grade 4
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 295 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 295 at risk

Adverse event: Guillian-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 295 at risk

Adverse event: PTLD
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 295 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 295 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 295 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 295 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 295 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 295 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 295 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 295 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 295 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 295 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 295 at risk

Adverse event: EKG Abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 8 affected / 295 at risk

Adverse event: Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 295 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 295 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 295 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 10 affected / 295 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 295 at risk

Adverse event: Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 295 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 295 at risk

Adverse event: HUS/TTP/thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 295 at risk

Adverse event: Vascular Leak Syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 295 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 45 affected / 295 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 295 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 18 affected / 295 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 295 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 295 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 295 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 57 affected / 295 at risk

Adverse event: EKG Abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 295 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 295 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 24 affected / 295 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 295 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 19 affected / 295 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 87 affected / 295 at risk

Adverse event: Liver Abnormality
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 295 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 66 affected / 295 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 295 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 295 at risk

Adverse event: Allergic Reaction / Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 295 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 295 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 295 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 14 affected / 295 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 295 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 295 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pulmoary embolus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 305 at risk

Adverse event: AV Block - third Degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Acute Mental Status Change
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 305 at risk

Adverse event: Urinary Frequency/urgency
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 305 at risk

Adverse event: Elevated Magnesium
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 305 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 305 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 305 at risk

Adverse event: Cerebrovascular Ischemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Thrombotic thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Superior sagittal sinus thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Death at home, unexpected
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 305 at risk

Adverse event: Pain, Site Right Kidney
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 305 at risk

Adverse event: Appendicectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 305 at risk

Adverse event: Photopsia
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 305 at risk

Adverse event: Somnolence
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 305 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 305 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 305 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 305 at risk

Adverse event: EKG Abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 305 at risk

Adverse event: Arrythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 305 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 16 affected / 305 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 305 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 305 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 17 affected / 305 at risk

Adverse event: Mucositis/Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 305 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 305 at risk

Adverse event: HUS/TTP/thrombotic microangiopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 305 at risk

Adverse event: Vascular Leak Syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 305 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 39 affected / 305 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 305 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 305 at risk

Adverse event: Vomitting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 305 at risk

Adverse event: Photopsia
Serious: no
Organ System: Eye disorders
Frequency: 19 affected / 305 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 305 at risk

Adverse event: Psychotic disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 27 affected / 305 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 305 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 49 affected / 305 at risk

Adverse event: EKG Abnormality
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 305 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 305 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 305 at risk

Adverse event: Left ventricular dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 305 at risk

Adverse event: Cystitis haemorrhagic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 305 at risk

Adverse event: Hepatic Dysfunction
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 101 affected / 305 at risk

Adverse event: Liver Abnormality
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 12 affected / 305 at risk

Adverse event: Mucositis/Stomatitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 62 affected / 305 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 305 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 305 at risk

Adverse event: Allergic Reaction / Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 5 affected / 305 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 305 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 305 at risk

Adverse event: Rigors, chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 305 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 305 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 305 at risk