Study: NCT00593645

Adverse event: Blood bilirubin
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Death - respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Patient died on day +26 of veno-occlusive disease
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Infection with Gr. 3/4 neutropenia
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis - Resulted in (2) deaths on day +15 and day +32
Frequency: 1 affected / 7 at risk

Adverse event: Mucosal inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Perforation, GI - colon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Blood uric acid
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: Death due to disease progression
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 7 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Blood alkaline phosphatase
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 7 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 7 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Blood blister - chin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 7 at risk

Adverse event: CNS hemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Catheter site
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 7 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 7 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 7 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Dental: teeth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 7 at risk

Adverse event: Distension/bloating
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 7 at risk

Adverse event: Dysgeusia/taste alteration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Edema - right eyelid
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Edema:limb
Serious: no
Organ System: General disorders
Frequency: 7 affected / 7 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Elevated uric acid
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Extremity pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 7 at risk

Adverse event: Eye hemorrage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 7 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 7 at risk

Adverse event: Fever in the absence of neutropenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 7 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Generalised oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Generalized pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: Generalized weakness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 7 at risk

Adverse event: Hand-foot reaction
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 7 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 7 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hemianopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Haemoglobin
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Hypermagnesaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Hypernatraemia
Serious: no
Organ System: Investigations
Frequency: 2 affected / 7 at risk

Adverse event: Hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 7 at risk

Adverse event: Hypoalbuminaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 7 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Investigations
Frequency: 1 affected / 7 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Investigations
Frequency: 6 affected / 7 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Investigations
Frequency: 3 affected / 7 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 7 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Infection with Gr. 3-4 neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 7 at risk

Adverse event: Infection with normal neutrophils
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 7 at risk

Adverse event: Large intestine infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 7 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Leukocytes (WBC)
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Leukoplakia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Line erythema/ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Liver abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

Adverse event: Lower gastrointestinal hemorrhage (NOS)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Mental status change
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 7 at risk

Adverse event: Mucosal inflammation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 7 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 7 at risk

Adverse event: Neck/chin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 7 at risk

Adverse event: Neuropathy - sensory
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 7 at risk

Adverse event: Febrile neutropenia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 7 at risk

Adverse event: Neutrophil count
Serious: no
Organ System: Investigations
Frequency: 5 affected / 7 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 7 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 4 affected / 7 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 7 at risk

Adverse event: Pneumonitis/pulmonary infiltrates
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pruritis/itching
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Eyelid ptosis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 7 at risk

Adverse event: Rash/desquamation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 7 at risk

Adverse event: Right-sided weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Rigors/chills
Serious: no
Organ System: General disorders
Frequency: 6 affected / 7 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 7 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 7 at risk

Adverse event: Scrotal chafing
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 7 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 7 at risk

Adverse event: Urinary frequency/urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 7 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 7 at risk