{"analyses":[{"ciLowerLimit":"0.44","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.00","groupDescription":"To detect an absolute difference of 20% in progression-free survival at 3-years between Arm I and Unfav-Dose-Dense Arm II (46% versus 66%) with the possibility that 80 events (progressive disease and death) may be observed during this period, a total of 196 participants, 98 per group needed to be included, with an additional 25% of patients for a total of 260 participants required.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.05","paramType":"Hazard Ratio (HR)","paramValue":"0.66","statisticalComment":"Adjusted on the stratification factor (treatment centers)","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38","upperLimit":"59","value":"48"},{"groupId":"OG001","lowerLimit":"49","upperLimit":"68","value":"59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"105"}],"units":"Participants"}],"description":"Primary objective is to compare the progression-free survival of participants after 1 cycle of treatment, treated randomly by 3 additional cycles of BEP (Arm I) or by T-BEP-Oxaliplatin/cisplatin-ifosfamide-Bleomycin (Arm II). The median progression-free survival rate was defined as the median percentage of participants alive without disease progression after 1 course of treatment.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP).\n\nbleomycin sulfate: At least one course administered\n\ncisplatin: At least one course administered\n\netoposide: At least one course administered","id":"OG000","title":"Arm I"},{"description":"Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide.\n\nbleomycin sulfate: At least one course administered\n\ncisplatin: At least one course administered\n\netoposide: At least one course administered\n\nifosfamide: Given in a dose-dense sequential fashion\n\noxaliplatin: Given in a dose-dense sequential fashion\n\npaclitaxel: Given in a dose-dense sequential fashion","id":"OG001","title":"Arm II"}],"paramType":"NUMBER","populationDescription":"The primary endpoint for the study was the comparison of the PFS rates in the population of participants with a poor prognostic non-seminomatous germ cell tumors and with an unfavorable decrease in tumor biomarkers, randomized to either Unfav-BEP Control Arm (Arm I) or Unfav-Dose-Dense Arm (Arm II).","reportingStatus":"POSTED","timeFrame":"3 years from randomization","title":"Progression-free Survival Rate After 1 Course of Treatment","type":"PRIMARY","unitOfMeasure":"percentage of participants"}