{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.2","upperLimit":"41.0","value":"27.7"},{"groupId":"OG001","lowerLimit":"10.4","upperLimit":"52.7","value":"19.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"31"},{"groupId":"OG001","value":"32"}],"units":"Participants"}],"description":"The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.\n\nCarboplatin: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies\n\nPaclitaxel: Given IV","id":"OG000","title":"Arm I (Paclitaxel, Carboplatin)"},{"description":"Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.\n\nBleomycin Sulfate: Given IV\n\nCisplatin: Given IV\n\nEtoposide Phosphate: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"OG001","title":"Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)"}],"paramType":"MEDIAN","populationDescription":"Intent to Treat","reportingStatus":"POSTED","timeFrame":"From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.","title":"Progression-free Survival (PFS)","type":"PRIMARY","unitOfMeasure":"months"}