{"denoms":[{"counts":[{"groupId":"BG000","value":"52"},{"groupId":"BG001","value":"381"},{"groupId":"BG002","value":"382"},{"groupId":"BG003","value":"571"},{"groupId":"BG004","value":"42"},{"groupId":"BG005","value":"153"},{"groupId":"BG006","value":"153"},{"groupId":"BG007","value":"1734"}],"units":"Participants"}],"groups":[{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG000","title":"Arm I (Patients Off-therapy Before Callback-Induction Only)"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG001","title":"Arm II (RER With CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG002","title":"Arm III (RER With CR [ABVE-PC])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG003","title":"Arm IV (RER With Less Than CR [ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG004","title":"Arm V (RER With PD)"},{"description":"Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, \\& cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 \\& 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 \\& G-CSF SC beginning on day 3 \\& continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCisplatin: Given IV\n\nCyclophosphamide: Given IV\n\nCytarabine: Given IV\n\nDexamethasone: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPre","id":"BG005","title":"Arm VI (SER [DECA, ABVE-PC, IFRT])"},{"description":"Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.\n\nBleomycin Sulfate: Given IV or SC\n\nCyclophosphamide: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nFilgrastim: Given SC\n\nInvolved-Field Radiation Therapy: Undergo IFRT\n\nPrednisone: Given orally\n\nVincristine Sulfate Liposome: Given IV","id":"BG006","title":"Arm VII (SER [ABVE-PC, IFRT])"},{"description":"Total of all reporting groups","id":"BG007","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"363"},{"groupId":"BG002","value":"369"},{"groupId":"BG003","value":"540"},{"groupId":"BG004","value":"40"},{"groupId":"BG005","value":"143"},{"groupId":"BG006","value":"148"},{"groupId":"BG007","value":"1649"}],"title":"<=18 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Categorical","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"5","upperLimit":"20","value":"16"},{"groupId":"BG001","lowerLimit":"2","upperLimit":"21","value":"14"},{"groupId":"BG002","lowerLimit":"3","upperLimit":"21","value":"14"},{"groupId":"BG003","lowerLimit":"1","upperLimit":"21","value":"15"},{"groupId":"BG004","lowerLimit":"5","upperLimit":"19","value":"15"},{"groupId":"BG005","lowerLimit":"5","upperLimit":"21","value":"15"},{"groupId":"BG006","lowerLimit":"5","upperLimit":"21","value":"15"},{"groupId":"BG007","lowerLimit":"1","upperLimit":"21","value":"15"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"Years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"177"},{"groupId":"BG002","value":"155"},{"groupId":"BG003","value":"288"},{"groupId":"BG004","value":"16"},{"groupId":"BG005","value":"81"},{"groupId":"BG006","value":"77"},{"groupId":"BG007","value":"815"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"204"},{"groupId":"BG002","value":"227"},{"groupId":"BG003","value":"283"},{"groupId":"BG004","value":"26"},{"groupId":"BG005","value":"72"},{"groupId":"BG006","value":"76"},{"groupId":"BG007","value":"919"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"67"},{"groupId":"BG003","value":"74"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"22"},{"groupId":"BG006","value":"14"},{"groupId":"BG007","value":"259"}],"title":"Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"293"},{"groupId":"BG002","value":"306"},{"groupId":"BG003","value":"487"},{"groupId":"BG004","value":"34"},{"groupId":"BG005","value":"127"},{"groupId":"BG006","value":"134"},{"groupId":"BG007","value":"1425"}],"title":"Not Hispanic or Latino"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"5"},{"groupId":"BG007","value":"50"}],"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":"1"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"4"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"11"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"4"},{"groupId":"BG006","value":"6"},{"groupId":"BG007","value":"50"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"2"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"6"}],"title":"Native Hawaiian or Other Pacific Islander"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"43"},{"groupId":"BG003","value":"67"},{"groupId":"BG004","value":"6"},{"groupId":"BG005","value":"14"},{"groupId":"BG006","value":"14"},{"groupId":"BG007","value":"194"}],"title":"Black or African American"},{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"290"},{"groupId":"BG002","value":"297"},{"groupId":"BG003","value":"444"},{"groupId":"BG004","value":"30"},{"groupId":"BG005","value":"122"},{"groupId":"BG006","value":"124"},{"groupId":"BG007","value":"1348"}],"title":"White"},{"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"}],"title":"More than one race"},{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"27"},{"groupId":"BG003","value":"45"},{"groupId":"BG004","value":"4"},{"groupId":"BG005","value":"12"},{"groupId":"BG006","value":"8"},{"groupId":"BG007","value":"132"}],"title":"Unknown or Not Reported"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Race (NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"3"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"4"}]}],"title":"New Zealand"},{"categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"45"},{"groupId":"BG003","value":"51"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"20"},{"groupId":"BG006","value":"20"},{"groupId":"BG007","value":"175"}]}],"title":"Canada"},{"categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"333"},{"groupId":"BG002","value":"312"},{"groupId":"BG003","value":"491"},{"groupId":"BG004","value":"39"},{"groupId":"BG005","value":"125"},{"groupId":"BG006","value":"128"},{"groupId":"BG007","value":"1469"}]}],"title":"United States"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"1"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"6"}]}],"title":"Israel"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"12"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"4"},{"groupId":"BG007","value":"40"}]}],"title":"Australia"},{"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":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"}]}],"title":"Switzerland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"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":"1"}]}],"title":"Kuwait"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"3"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"22"}]}],"title":"Netherlands"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"1"},{"groupId":"BG006","value":"1"},{"groupId":"BG007","value":"13"}]}],"title":"Puerto Rico"},{"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":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"}]}],"title":"Bermuda"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"1"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"},{"groupId":"BG007","value":"1"}]}],"title":"French Polynesia"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"}]}