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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000328-47 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Experimental | Children aged 1 to <18 years weighing 6 to <35 kg randomized to apixaban will receive a fixed dose apixaban based on body weight tier twice a day for approximately 28 days. Children aged 1 to <18 years weighing ≥ 35 kg will receive 2.5 mg of apixaban twice a day for approximately 28 days. Subjects ≥ 5 years may be administered either 2.5-mg, 0.5-mg tablets or oral solution apixaban. Subjects < 5years and < 35 kg may be administered 0.5-mg tablets only |
|
| No systemic anticoagulant prophylaxis | Placebo Comparator | No systemic anticoagulant prophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
| ||
| No systemic anticoagulant prophylaxis |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death | The number of participants with non-fatal deep vein thromboses (DVT) (including asymptomatic and symptomatic), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE) related-death objectively confirmed by a blinded, independent adjudication committee. Symptomatic events are included during the intended treatment period. Asymptomatic events are included from scans up to Day 40. | From first dose up to approximately 40 days after first dose |
| The Number of Participants With Adjudicated Major Bleeding | The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria:
| From first dose up to approximately 34 days after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT) | The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 40 days after first dose |
| The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT) |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr. | Phoenix | Arizona | 85016 | United States | ||
| City of Hope |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40505060 | Derived | Rodriguez V, O'Brien SH, Orgel E, Schultz CL, Esbenshade AJ, Memaj A, Dyme JL, Favatella NA, Mitchell LG. Safety and efficacy of apixaban thrombosis prevention in pediatric patients with obesity and acute lymphoblastic leukemia. Blood Adv. 2025 Sep 23;9(18):4738-4747. doi: 10.1182/bloodadvances.2025016160. | |
| 37980924 | Derived |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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512 participants were randomized. 256 is the number of subjects who randomized to each of Apixaban or Standard of Care arm respectively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Apixaban | Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase. Weight range - Dose >/=35 kg - 2.5 mg twice daily <35 to 25 kg - 2 mg twice daily <25 to 18 kg - 1.5 mg twice daily <18 to 10.5 kg - 1 mg twice daily <10.5 to 6 kg - 0.5 mg twice daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2020 | Jan 6, 2022 |
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|
The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee |
| From first dose up to approximately 34 days after first dose |
| The Number of Participants With Non-fatal Pulmonary Embolism (PE) | The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 34 days after first dose |
| The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST) | The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 34 days after first dose |
| The Number of Participants With Venous Thromboembolism (VTE)-Related-death | The number of participants with venous thromboembolism (VTE)-related-death adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 34 days after first dose |
| The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB) | The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee CRNM bleeding is defined as bleeding that satisfies one or both of the following:
| From first dose up to approximately 34 days after first dose |
| The Number of Participant Deaths | The number of participant deaths adjudicated by a blinded, independent adjudication committee | From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days) |
| The Number of Participants With an Arterial Thromboembolic Event | The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 34 days after first dose |
| The Number of Participants With a CVAD-Related Infection | The number of participants with a central venous access device (CVAD)-related infection adjudicated by a blinded, independent adjudication committee | From first dose up to approximately 34 days after first dose |
| The Number of Participants Needing Catheter Replacements During the Study | The number of participants needing catheter replacements during the study | From first dose up to approximately 34 days after first dose |
| The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use | The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use | From first dose up to approximately 34 days after first dose |
| The Number Participants Experiencing Superficial Vein Thrombosis Events | The number participants experiencing superficial vein thrombosis events. Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging. | From first dose up to approximately 34 days after first dose |
| The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB) | The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee. CRNM bleeding is defined as bleeding that satisfies one or both of the following:
| From first dose up to approximately 34 days after first dose |
| The Number of Participants With Minor Bleeding Events | The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee. Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB | From first dose up to approximately 34 days after first dose |
| The Number of Platelet Transfusions Needed During the Study | The number of platelet transfusions needed during the study. The events are not adjudicated. A subject could have more than one platelet transfusion. | From first dose up to approximately 34 days after first dose |
| Maximum Observed Concentration (Cmax) | The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | pre-dose, 1-4 hours post dose |
| Trough Observed Concentration (Cmin) | The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | pre-dose, 1-4 hours post dose |
| Area Under the Concentration-Time Curve [AUC(TAU)] | The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | pre-dose, 1-4 hours post dose |
| Anti-FXa Activity | Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy | pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15. |
| Duarte |
| California |
| 91010 |
| United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92350 | United States |
| Childrens Hospital Of La | Los Angeles | California | 90027 | United States |
| Children'S Hospital Of Orange County | Orange | California | 92868 | United States |
| Lucile Packard Children's Hospital (LPCH) | Palo Alto | California | 94304 | United States |
| Rady Children'S Hospital - San Diego | San Diego | California | 92123-4282 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06520 | United States |
| Nemours / A. I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Golisano Childrens Hospital of Southwest Florida | Fort Myers | Florida | 33908 | United States |
| Shands Hospital At University Of Florida | Gainesville | Florida | 32610-0298 | United States |
| Nemours Children'S Clinic | Jacksonville | Florida | 32207 | United States |
| Nemours Children'S Clinic - Orlando | Orlando | Florida | 32827 | United States |
| Nemours Children'S Clinic-Pensacola | Pensacola | Florida | 32504 | United States |
| All Childrens Hospital Specialty Physicians | St. Petersburg | Florida | 33701 | United States |
| St. Marys Medical Center | West Palm Beach | Florida | 33407 | United States |
| Childrens Healthcare Of Atlanta - E | Atlanta | Georgia | 30342 | United States |
| Navicent Health Physician Group | Macon | Georgia | 31201 | United States |
| St. Luke'S Mountain State Tumor Institute | Boise | Idaho | 83712 | United States |
| Children'S Center For Cancer And Blood Diseases | Indianapolis | Indiana | 46260 | United States |
| Blank Childrens Hospital | Des Moines | Iowa | 50309 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kentucky | Lexington | Kentucky | 40536-0293 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Childrens Hospital New Orleans | New Orleans | Louisiana | 70118 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Sinai Hospital Of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University Of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| Childrens Hospitals And Clinics Of Minnesota | Minneapolis | Minnesota | 55404 | United States |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University Of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| Valerie Fund Children's Center at St. Joseph's Children's Hospital | Paterson | New Jersey | 07503 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| University Of Rochester General Clinical Research Center | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| Unv. Of Nc At Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Akron Children'S Hospital | Akron | Ohio | 44308 | United States |
| Cincinnati Children'S Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| University Hospitals | Cleveland | Ohio | 44106 | United States |
| Nationwide Children'S Hospital | Columbus | Ohio | 43205 | United States |
| Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | 18017 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital Of Pittsburgh Of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Children's Hospital at TriStar Centennial | Nashville | Tennessee | 37203 | United States |
| Monroe Carell Jr Children'S Hosp. At Vanderbilt Tower | Nashville | Tennessee | 37232 | United States |
| Dell Children'S Medical Center Of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children'S Hospital | Corpus Christi | Texas | 78411 | United States |
| Texas Children's Cancer and Hematology Centers | Houston | Texas | 77030 | United States |
| Children's Hospital of San Antonio | San Antonio | Texas | 78207 | United States |
| University Hospital | San Antonio | Texas | 78284 | United States |
| Scott & White - McLane Children's Specialty Clinic | Temple | Texas | 76502 | United States |
| Providence Sacred Heart Medical Center | Spokane | Washington | 99204 | United States |
| MultiCare Institute for Research & Innovation | Tacoma | Washington | 98405 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Local Institution | New Lambton Heights | New South Wales | 2305 | Australia |
| Queensland Children's Hospital | Sth Brisbane | Queensland | 4101 | Australia |
| Monash Medical Centre Clayton | Clayton | Victoria | 3168 | Australia |
| Local Institution | Parkville | Victoria | 3052 | Australia |
| Local Institution | Brussels | 1020 | Belgium |
| Local Institution | Brussels | 1200 | Belgium |
| Local Institution | Edegem | 2650 | Belgium |
| Local Institution | Ghent | 9000 | Belgium |
| Local Institution | Leuven | 3000 | Belgium |
| Alberta Children'S Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| Local Institution | Edmonton | Alberta | T6G 2B7 | Canada |
| Local Institution | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Children'S Hospital London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Children'S Hospital Of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Klinika detske onkologie | Brno | 613 00 | Czechia |
| Local Institution | Budapest | 1094 | Hungary |
| Local Institution | Debrecen | 4032 | Hungary |
| Local Institution | Pécs | 7623 | Hungary |
| Local Institution | Guadalajara | Jalisco | 44340 | Mexico |
| Local Institution | Df | Mexico City | 04530 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Christchurch | 8011 | New Zealand |
| Klinika Transplantacji Szpiku Onkologii i Hematologii Dzieciecej | Wroclaw | 50-556 | Poland |
| Oddzial Hematologii i Onkologii Dzieciecej | Zabrze | 41-800 | Poland |
| Local Institution | Caguas | 00725 | Puerto Rico |
| Local Institution | Kirov | 610027 | Russia |
| Local Institution | Moscow | 115478 | Russia |
| Local Institution | Moscow | 117198 | Russia |
| Local Institution | Saint Petersburg | 197341 | Russia |
| Local Institution | Saint Petersburg | 197758 | Russia |
| Local Institution | Seoul | 03080 | South Korea |
| Local Institution | Seoul | 03722 | South Korea |
| O'Brien SH, Rodriguez V, Lew G, Newburger JW, Schultz CL, Orgel E, Derr K, Ranalli MA, Esbenshade AJ, Hochberg J, Kang HJ, Dinikina Y, Mills D, Donovan M, Dyme JL, Favatella NA, Mitchell LG; PREVAPIX-ALL investigators. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial. Lancet Haematol. 2024 Jan;11(1):e27-e37. doi: 10.1016/S2352-3026(23)00314-9. Epub 2023 Nov 16. |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Standard of Care | No systemic anticoagulant prophylaxis during induction chemotherapy |
| Adverse Event Analysis Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Apixaban | Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase. Weight range - Dose >/=35 kg - 2.5 mg twice daily <35 to 25 kg - 2 mg twice daily <25 to 18 kg - 1.5 mg twice daily <18 to 10.5 kg - 1 mg twice daily <10.5 to 6 kg - 0.5 mg twice daily |
| BG001 | Standard of Care | No systemic anticoagulant prophylaxis during induction chemotherapy |
| BG002 | 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | The Number of Participants With Non-Fatal DVT, PE, and CVST, and VTE-Related-Death | The number of participants with non-fatal deep vein thromboses (DVT) (including asymptomatic and symptomatic), pulmonary embolism (PE), cerebral venous sinus thrombosis (CVST); and venous thromboembolism (VTE) related-death objectively confirmed by a blinded, independent adjudication committee. Symptomatic events are included during the intended treatment period. Asymptomatic events are included from scans up to Day 40. | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 40 days after first dose |
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| Primary | The Number of Participants With Adjudicated Major Bleeding | The number of participants with major bleeding adjudicated by a blinded, independent adjudication committee. Adjudicated major bleeding is defined as bleeding that satisfies one or more of the following criteria:
| Safety Population | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Non-fatal Asymptomatic Deep Vein Thromboses (DVT) | The number of participants with non-fatal asymptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 40 days after first dose |
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| Secondary | The Number of Participants With Non-fatal Symptomatic Deep Vein Thromboses (DVT) | The number of participants with non-fatal symptomatic deep vein thromboses (DVT) adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
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| Secondary | The Number of Participants With Non-fatal Pulmonary Embolism (PE) | The number of participants with non-fatal pulmonary embolism (PE) adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
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| Secondary | The Number of Participants With Cerebral Venous Sinus Thrombosis (CVST) | The number of participants with cerebral venous sinus thrombosis (CVST) adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
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| Secondary | The Number of Participants With Venous Thromboembolism (VTE)-Related-death | The number of participants with venous thromboembolism (VTE)-related-death adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
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| Secondary | The Number of Participants With Major and Clinically Relevant Non-Major Bleeding (CRNMB) | The number of participants with major and clinically relevant non-major bleeding (CRNMB) adjudicated by a blinded, independent adjudication committee CRNM bleeding is defined as bleeding that satisfies one or both of the following:
| Safety Population | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participant Deaths | The number of participant deaths adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose date until the end of the treatment period + 30 days (Up to approximately 59 days) |
|
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| Secondary | The Number of Participants With an Arterial Thromboembolic Event | The number of participants with an arterial thromboembolic event including paradoxical embolism and stroke adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
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| Secondary | The Number of Participants With a CVAD-Related Infection | The number of participants with a central venous access device (CVAD)-related infection adjudicated by a blinded, independent adjudication committee | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
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| Secondary | The Number of Participants Needing Catheter Replacements During the Study | The number of participants needing catheter replacements during the study | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With CVAD Patency Restoration Events After Thrombolytic Therapy Use | The number of participants with central venous access device (CVAD) patency restoration events after thrombolytic therapy use | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
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| Secondary | The Number Participants Experiencing Superficial Vein Thrombosis Events | The number participants experiencing superficial vein thrombosis events. Clots that occur in a superficial vein ie, cephalic vein, basilic vein (upper extremity) or saphenous vein (lower extremity) confirmed by radiographic imaging. | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Clinically Relevant Non-Major Bleeding Events (CRNMB) | The number of participants with clinically relevant non-major bleeding events (CRNMB) adjudicated by a blinded, independent adjudication committee. CRNM bleeding is defined as bleeding that satisfies one or both of the following:
| All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Minor Bleeding Events | The number of participants with minor bleeding events adjudicated by a blinded, independent adjudication committee. Minor bleeding defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNMB | All randomized participants | Posted | Count of Participants | Participants | From first dose up to approximately 34 days after first dose |
|
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| Secondary | The Number of Platelet Transfusions Needed During the Study | The number of platelet transfusions needed during the study. The events are not adjudicated. A subject could have more than one platelet transfusion. | All randomized participants | Posted | Number | Platelet Transfusions | From first dose up to approximately 34 days after first dose |
|
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| Secondary | Maximum Observed Concentration (Cmax) | The maximum observed concentration (Cmax) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | All randomized participants in the apixaban arm with available pharmacokinetic data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1-4 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough Observed Concentration (Cmin) | The trough observed concentration (Cmin) was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | All randomized participants in the apixaban arm with available pharmacokinetic data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | pre-dose, 1-4 hours post dose |
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| Secondary | Area Under the Concentration-Time Curve [AUC(TAU)] | The area under the concentration-time curve [AUC(TAU)] was measured to assess the pharmacokinetics of oral or enteric apixaban in pediatric subjects receiving induction chemotherapy. | All randomized participants in the apixaban arm with available pharmacokinetic data | Posted | Geometric Mean | Geometric Coefficient of Variation | ng•h/mL | pre-dose, 1-4 hours post dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Anti-FXa Activity | Anti-FXa Activity was measured to characterize the relationship between apixaban plasma concentration and anti-FXa activity in pediatric subjects receiving induction chemotherapy | All randomized participants in the apixaban arm with available pharmacodynamic data | Posted | Mean | Standard Deviation | Anti-FXa activity (ng/mL) | pre-dose and 2.5 hours after dosing on day 7. Day 8 and day 15. |
|
AEs are collected from the first dose date until the end of the treatment period + 2 days (Up to approximately 31 days) SAEs are collected from the first dose date until the end of the treatment period + 30 days (Up to approximately 59 days). All Cause Mortality was collected from first dose up to DBL date: Sep-13-2021 (up to approximately 6 years.)
Not provided
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 | Apixaban | Participants will be administered apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase | 1 | 250 | 91 | 250 | 204 | 250 |
| EG001 | Standard of Care | No systemic anticoagulant prophylaxis during induction chemotherapy | 4 | 262 | 83 | 262 | 193 | 262 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile bone marrow aplasia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Intracardiac thrombus | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumopericardium | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ocular hypertension | Eye disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Proctitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Haemophilus bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Infective thrombosis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatococcal infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Epidural haemorrhage | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Meningitis chemical | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Human rhinovirus test positive | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebral venous sinus thrombosis | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Leukoencephalopathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Posterior reversible encephalopathy syndrome | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Testicular cyst | Reproductive system and breast disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Subclavian vein thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2021 | Jan 6, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522181 | apixaban |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| OG003 |
| Participants Weight Range 10.5 to < 18 kg |
Participants will be administered 1mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase |
|
|
| OG003 |
| Participants Weight Range 10.5 to < 18 kg |
Participants will be administered 1mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase |
|
|
| OG003 | Participants Weight Range 10.5 to < 18 kg | Participants will be administered 1mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase |
|
|
| OG003 | Participants Weight Range 10.5 to < 18 kg | Participants will be administered 1mg apixaban twice daily by mouth or via a NGT or GT according to weight range during approximately 28 days of induction chemotherapy including asparaginase |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|