Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, multi-center, open-label, parallel group study with three arms:
The primary objective is to compare the adequacy of control of plasma uric acid concentration and the safety profile among the three arms.
After signing the informed consent and having met the inclusion criteria, patients will be randomized to 1 of the 3 arms and treated for a total duration of 5 days. Patients in all arms will receive chemotherapy beginning 4-24 hours after the first dose of rasburicase or allopurinol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Rasburicase alone given as a single agent for 5 days |
|
| Arm B | Experimental | Rasburicase alone given as a single agent from Day 1 through Day 3, followed by oral allopurinol given from Day 3 through Day 5 (Day 3 is an overlap) |
|
| Arm C | Active Comparator | Oral allopurinol alone given as a single agent for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasburicase (SR29142) | Drug | 30-min IV infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Uric Acid Responder | Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl. | Day 3 through Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Uric Acid | Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values | Day 1 to Day 7 |
| Time to Uric Acid Control | Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion. |
Not provided
Inclusion Criteria:
Meets high risk or at potential risk for tumor lysis syndrome (TLS):
A patient is at high risk for TLS if he/she presents with:
A patient is at potential risk for TLS if he/she presents with:
A diagnosis of aggressive lymphoma/leukemia based on the REAL classification of lymphoma/leukemia plus 1 or more of the following criteria:
In addition to the above-mentioned eligibility criteria, the patients should have the following criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Age >= 18 years
Life expectancy > 3 months
Negative pregnancy test (females of child bearing potential) and use of effective contraceptive method (for both males and females). A pregnancy test may be performed on serum or urine human chorionic gonadotropin (HCG).
Signed written informed consent
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| International Clinical Development | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alta Bates Comprehensive Cancer Center | Berkeley | California | 94704 | United States | ||
| UCLA Medical Center |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rasburicase | Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days |
| FG001 | Rasburicase + Allopurinol | Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Allopurinol |
| Drug |
Oral administration |
|
| Day 1 to Day 7 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| University of Florida Health Science Center at Jacksonville | Jacksonville | Florida | 32209 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Oregon Health and Sciences University | Portland | Oregon | 97201 | United States |
| University of Pennsylvania Health Systems | Philadelphia | Pennsylvania | 19194 | United States |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Mary Babb Randolph Cancer Center | Morgantown | West Virginia | 26506-9162 | United States |
| FG002 | Allopurinol | Allopurinol (300 mg/day) given alone as a single agent for 5 days |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rasburicase | Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days |
| BG001 | Rasburicase + Allopurinol | Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap) |
| BG002 | Allopurinol | Allopurinol (300 mg/day) given alone as a single agent for 5 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma Uric Acid Responder | Number of patients responding to treatment defined as plasma uric acid levels at Day 3 through Day 7 <7.5 mg/dl. | Posted | Number | Participants | Day 3 through Day 7 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasma Uric Acid | Area under the curve concentration versus time curve extrapolated to infinity (AUC) of plasma uric acid values | The analysis was performed on the modified ITT-population with an evaluation of plasma uric acid AUC. | Posted | Mean | Standard Deviation | mg*h/dL | Day 1 to Day 7 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Uric Acid Control | Time from the first dose of study drug to the time at which plasma uric acid concentrations were determined <=7.5 mg/dl, measured -4, 4, 24, 48, 72, 96, 120, and 144 hours after infusion. | The analysis was performed on a subgroup of patients from the mITT-population with hyperuricemia immediately prior to the first dose of study drug. | Posted | Median | 95% Confidence Interval | Hours | Day 1 to Day 7 |
|
|
Time from the first study drug intake until a maximum follow-up of 30 days after the last dose of antihyperuricemic treatment.
Reported events are treatment emergent adverse events within the time frame mentioned above.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rasburicase | Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days | 36 | 92 | 91 | 92 | ||
| EG001 | Rasburicase + Allopurinol | Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap) | 32 | 92 | 92 | 92 | ||
| EG002 | Allopurinol | Allopurinol (300 mg/day) given alone as a single agent for 5 days | 29 | 91 | 90 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenic infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tumor lysis syndrom | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrom | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhage intracanial | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neurological symptom | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ear and labyrinth disorder | Ear and labyrinth disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Transfusion reaction | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood alkaline phophatase increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood lactate dehydrogenase decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Reproductive system and breast disorders | Reproductive system and breast disorders | MedDRA (10.1) | Non-systematic Assessment |
|
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| International Clinical Development, Clinical Study Director | Sanofi-aventis | GV-Contact-us@sanofi-aventis.com |
| ID | Term |
|---|---|
| D015275 | Tumor Lysis Syndrome |
| D009369 | Neoplasms |
| D033461 | Hyperuricemia |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
| D006402 | Hematologic Diseases |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C469709 | rasburicase |
| D014503 | Urate Oxidase |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Title | Measurements |
|---|---|
|
| Difference in response rate % |
| 12.3 |
| 95 |
| -0.9 |
| 25.0 |
| No |
| Superiority or Other |
|
|
|
|