{"denoms":[{"counts":[{"groupId":"BG000","value":"246"},{"groupId":"BG001","value":"106"},{"groupId":"BG002","value":"296"},{"groupId":"BG003","value":"246"},{"groupId":"BG004","value":"232"},{"groupId":"BG005","value":"710"},{"groupId":"BG006","value":"246"},{"groupId":"BG007","value":"696"},{"groupId":"BG008","value":"302"},{"groupId":"BG009","value":"34"},{"groupId":"BG010","value":"12"},{"groupId":"BG011","value":"28"},{"groupId":"BG012","value":"3154"}],"units":"Participants"}],"groups":[{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG000","title":"Dexamethasone and Capizzi Methotrexate Patients < 10 Years"},{"description":"Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG001","title":"Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)"},{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG002","title":"Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG003","title":"Dexamethasone, High Dose Methotrexate (IM) < 10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"BG004","title":"Prednisone, Capizzi Methotrexate <10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"BG005","title":"Prednisone, Capezzi Methotrexate >= 10 Years"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"BG006","title":"Prednisone and High Dose Methotrexate < 10 Yrs Old"},{"description":"Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"BG007","title":"Prednisone and High Dose Methotrexate >=10 Years"},{"description":"Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG008","title":"Dexamethasone, High Dose Methotrexate (IM) >= 10 Years"},{"description":"Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.","id":"BG009","title":"Prednisone, Capezzi Methotrexate (Down's Syndrome)"},{"description":"Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 \\& 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).","id":"BG010","title":"Dexamethasone, Capizzi Methotrexate Down Syndrome"},{"description":"Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth","id":"BG011","title":"Prednisone and High Dose Methotrexate (Non Randomly Assigned)"},{"description":"Total of all reporting groups","id":"BG012","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"246"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"275"},{"groupId":"BG003","value":"246"},{"groupId":"BG004","value":"232"},{"groupId":"BG005","value":"641"},{"groupId":"BG006","value":"246"},{"groupId":"BG007","value":"610"},{"groupId":"BG008","value":"266"},{"groupId":"BG009","value":"30"},{"groupId":"BG010","value":"10"},{"groupId":"BG011","value":"26"},{"groupId":"BG012","value":"2924"}],"title":"<=18 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"69"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"86"},{"groupId":"BG008","value":"36"},{"groupId":"BG009","value":"4"},{"groupId":"BG010","value":"2"},{"groupId":"BG011","value":"2"},{"groupId":"BG012","value":"230"}],"title":"Between 18 and 65 years"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"0"},{"groupId":"BG008","value":"0"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"0"}],"title":">=65 years"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","spread":"2.3","value":"4.0"},{"groupId":"BG001","spread":"6.0","value":"9.3"},{"groupId":"BG002","spread":"2.8","value":"14.1"},{"groupId":"BG003","spread":"2.2","value":"4.1"},{"groupId":"BG004","spread":"2.2","value":"4.2"},{"groupId":"BG005","spread":"3.3","value":"14.7"},{"groupId":"BG006","spread":"2.2","value":"4.2"},{"groupId":"BG007","spread":"3.2","value":"14.5"},{"groupId":"BG008","spread":"2.9","value":"14.6"},{"groupId":"BG009","spread":"5.7","value":"10.5"},{"groupId":"BG010","spread":"6.6","value":"12.3"},{"groupId":"BG011","spread":"2.9","value":"14.4"},{"groupId":"BG012","spread":"5.7","value":"10.8"}]}]}],"dispersionType":"STANDARD_DEVIATION","paramType":"MEAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"129"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"135"},{"groupId":"BG003","value":"117"},{"groupId":"BG004","value":"106"},{"groupId":"BG005","value":"321"},{"groupId":"BG006","value":"108"},{"groupId":"BG007","value":"288"},{"groupId":"BG008","value":"128"},{"groupId":"BG009","value":"18"},{"groupId":"BG010","value":"7"},{"groupId":"BG011","value":"11"},{"groupId":"BG012","value":"1399"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"117"},{"groupId":"BG001","value":"75"},{"groupId":"BG002","value":"161"},{"groupId":"BG003","value":"129"},{"groupId":"BG004","value":"126"},{"groupId":"BG005","value":"389"},{"groupId":"BG006","value":"138"},{"groupId":"BG007","value":"408"},{"groupId":"BG008","value":"174"},{"groupId":"BG009","value":"16"},{"groupId":"BG010","value":"5"},{"groupId":"BG011","value":"17"},{"groupId":"BG012","value":"1755"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"62"},{"groupId":"BG003","value":"55"},{"groupId":"BG004","value":"62"},{"groupId":"BG005","value":"167"},{"groupId":"BG006","value":"61"},{"groupId":"BG007","value":"168"},{"groupId":"BG008","value":"69"},{"groupId":"BG009","value":"6"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"7"},{"groupId":"BG012","value":"733"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"179"},{"groupId":"BG001","value":"81"},{"groupId":"BG002","value":"217"},{"groupId":"BG003","value":"182"},{"groupId":"BG004","value":"165"},{"groupId":"BG005","value":"516"},{"groupId":"BG006","value":"179"},{"groupId":"BG007","value":"504"},{"groupId":"BG008","value":"219"},{"groupId":"BG009","value":"27"},{"groupId":"BG010","value":"10"},{"groupId":"BG011","value":"20"},{"groupId":"BG012","value":"2299"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"27"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"24"},{"groupId":"BG008","value":"14"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"2"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"122"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Ethnicity (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"7"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"1"},{"groupId":"BG010","value":"2"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"18"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"9"},{"groupId":"BG004","value":"7"},{"groupId":"BG005","value":"21"},{"groupId":"BG006","value":"8"},{"groupId":"BG007","value":"27"},{"groupId":"BG008","value":"18"},{"groupId":"BG009","value":"2"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"117"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"5"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"6"},{"groupId":"BG008","value":"2"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"25"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"15"},{"groupId":"BG005","value":"55"},{"groupId":"BG006","value":"14"},{"groupId":"BG007","value":"51"},{"groupId":"BG008","value":"19"},{"groupId":"BG009","value":"2"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"1"},{"groupId":"BG012","value":"219"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"196"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"235"},{"groupId":"BG003","value":"187"},{"groupId":"BG004","value":"175"},{"groupId":"BG005","value":"534"},{"groupId":"BG006","value":"187"},{"groupId":"BG007","value":"519"},{"groupId":"BG008","value":"227"},{"groupId":"BG009","value":"26"},{"groupId":"BG010","value":"9"},{"groupId":"BG011","value":"24"},{"groupId":"BG012","value":"2395"}],"title":"White"},{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"8"},{"groupId":"BG004","value":"5"},{"groupId":"BG005","value":"8"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"4"},{"groupId":"BG008","value":"3"},{"groupId":"BG009","value":"0"},{"groupId":"BG010","value":"0"},{"groupId":"BG011","value":"0"},{"groupId":"BG012","value":"40"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"27"},{"groupId":"BG004","value":"29"},{"groupId":"BG005","value":"83"},{"groupId":"BG006","value":"26"},{"groupId":"BG007","value":"82"},{"groupId":"BG008","value":"31"},{"groupId":"BG009","value":"3"},{"groupId":"BG010","value":"1"},{"groupId":"BG011","value":"3"},{"groupId":"BG012","value":"340"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"}]}