{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"27"}]}]}],"denomUnitsSelected":"Reporting Periods","denoms":[{"counts":[{"groupId":"OG000","value":"145"},{"groupId":"OG001","value":"150"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"527"},{"groupId":"OG001","value":"576"}],"units":"Reporting Periods"}],"description":"The number of induction or consolidation reporting periods in which a CTC version 4 codeable grade 4 or greater non-hematological adverse event, grade 3 or greater left ventricular systolic dysfunction or the reporting period is terminated because of a CTC codeable event.","groups":[{"description":"INDUCTION THERAPY: Patients receive Induction therapy with alternating cycles of VDC and IE given every 2 weeks for 6 cycles.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy with alternating cycles of VDC and IE given every 2 weeks for 8 cycles.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"OG000","title":"Regimen A (VDC/IE)"},{"description":"INDUCTION THERAPY: Patients receive Induction therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11.\n\nLOCAL CONTROL THERAPY: Between weeks 13-18, patients undergo surgery and/or radiation therapy.\n\nCONSOLIDATION THERAPY: Patients receive Consolidation therapy as in Regimen A and receive ganitumab IV over 30-60 minutes or 60-120 minutes on day 1 of weeks 7, 9, 11, 13, and 15.\n\nMETASTATIC SITE IRRADIATION: Patients with lung metastases undergo whole lung radiation and patients with bone metastases undergo definitive SBRT or EBRT.\n\nMAINTENANCE: Patients receive ganitumab IV over 30-60 minutes or 60-120 minutes every 3 weeks for 8 cycles.\n\nCyclophosphamide: Given IV\n\nDoxorubicin: Given IV\n\nDoxorubicin Hydrochloride: Given IV\n\nEtoposide: Given IV\n\nEtoposide Phosphate: Given IV\n\nExternal Beam Radiation Therapy: Undergo EBRT\n\nGanitumab: Given IV\n\nIfosfamide: Given IV\n\nStereotactic Radiosurgery: Undergo SBRT\n\nTherapeutic Surgical Procedure: Undergo surgery\n\nVincristine: Given IV\n\nVincristine Sulfate: Given IV","id":"OG001","title":"Regimen B (VDC/IE + Ganitumab)"}],"paramType":"NUMBER","populationDescription":"Only eligible patients who received at least one dose of assigned protocol therapy are considered in the calculation of this outcome measure. Five hundred twenty-seven (527) reporting periods were contributed by patients enrolled on Regimen A; Five hundred seventy-six 576 reporting periods were contributed by patients enrolled on Regimen B.","reportingStatus":"POSTED","timeFrame":"Up to 202 days","title":"Frequency of Toxicity-events","type":"SECONDARY","typeUnitsAnalyzed":"Reporting Periods","unitOfMeasure":"Reporting Periods"}