Study: NCT00027846

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 281 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 8 affected / 281 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 281 at risk

Adverse event: Transfusion: pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 281 at risk

Adverse event: Cardiovascular/General - Other (Specify)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 281 at risk

Adverse event: Constitutional Symptoms - Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 281 at risk

Adverse event: Radiation dermatitis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 281 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 281 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 281 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 281 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 281 at risk

Adverse event: Gastrointestinal - Other (Specify)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 281 at risk

Adverse event: Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 281 at risk

Adverse event: Blood alkaline phosphatase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 281 at risk

Adverse event: SGOT (AST)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 281 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 281 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 281 at risk

Adverse event: Febrile neutropenia (fever unknown origin no clinically or microbiologically documented infection)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 281 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 281 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 281 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 281 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 281 at risk

Adverse event: Hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 281 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 281 at risk

Adverse event: Mood alteration-depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 281 at risk

Adverse event: Neuropathy - cranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 281 at risk

Adverse event: Neuropathy - motor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 281 at risk

Adverse event: Personality/behavioral
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 281 at risk

Adverse event: Seizure(s)
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 281 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 281 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 281 at risk

Adverse event: Pulmonary - Other (Specify)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 281 at risk

Adverse event: Incontinence
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 281 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 281 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 281 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 281 at risk

Adverse event: Inner ear/hearing
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hemoglobin (Hgb)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 28 affected / 64 at risk

Adverse event: Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Leukocytes (total WBC)
Serious: yes
Organ System: Investigations
Frequency: 40 affected / 64 at risk

Adverse event: Lymphopenia
Serious: yes
Organ System: Investigations
Frequency: 15 affected / 64 at risk

Adverse event: Neutrophils/granulocytes (ANC/AGC)
Serious: yes
Organ System: Investigations
Frequency: 40 affected / 64 at risk

Adverse event: Platelets
Serious: yes
Organ System: Investigations
Frequency: 25 affected / 64 at risk

Adverse event: Transfusion: Platelets
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 64 at risk

Adverse event: Transfusion: pRBCs
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 64 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Thrombosis/embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 64 at risk

Adverse event: Partial thromboplastin time (PTT)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 64 at risk

Adverse event: Constitutional Symptoms - Other (Specify)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Wound-infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 64 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 64 at risk

Adverse event: Diarrhea (without colostomy)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Dysphagia, esophagitis, odynophagia (painful swallowing)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Typhlitis (inflammation of cecum)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 64 at risk

Adverse event: SGPT (ALT)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 64 at risk

Adverse event: Catheter-related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Febrile neutropenia (fever unknown origin no clinically or microbiologically documented infection)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 64 at risk

Adverse event: Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 64 at risk

Adverse event: Infection with unknown ANC
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 64 at risk

Adverse event: Infection without neutropenia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 64 at risk

Adverse event: Amylase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 64 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypernatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 64 at risk

Adverse event: Lipase
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 64 at risk

Adverse event: Ataxia (incoordination)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Depressed level of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Extrapyramidal/involuntary movement/restlessness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Irritability (<3yrs of age)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 64 at risk

Adverse event: Mood alteration-anxiety, agitation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 64 at risk

Adverse event: Seizure(s)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 64 at risk

Adverse event: Neurology - Other (Specify)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Ocular/Visual - Other (Specify)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 64 at risk

Adverse event: Abdominal pain or cramping
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 64 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 64 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 64 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 64 at risk

Adverse event: Hemoglobin (Hgb)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 64 at risk

Adverse event: Leukocytes (total WBC)
Serious: no
Organ System: Investigations
Frequency: 8 affected / 64 at risk

Adverse event: Platelets
Serious: no
Organ System: Investigations
Frequency: 7 affected / 64 at risk

Adverse event: Fatigue (lethargy, malaise, asthenia)
Serious: no
Organ System: General disorders
Frequency: 6 affected / 64 at risk

Adverse event: Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 109/L)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 64 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 64 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 64 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 64 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 64 at risk

Adverse event: SGOT (AST)
Serious: no
Organ System: Investigations
Frequency: 6 affected / 64 at risk

Adverse event: SGPT (ALT)
Serious: no
Organ System: Investigations
Frequency: 7 affected / 64 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 64 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 64 at risk