{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"}]}],"title":"Disease Progression"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}]}],"title":"Indeterminate"}],"denoms":[{"counts":[{"groupId":"OG000","value":"46"}],"units":"Participants"}],"description":"Primary outcome measured according to RECIST v1.0 Best Response:\n\nComplete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry.\n\nPartial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.","groups":[{"description":"Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy","id":"OG000","title":"Paclitaxel Followed by Carboplatin"}],"paramType":"NUMBER","populationDescription":"Total eligible and treated participants","reportingStatus":"POSTED","timeFrame":"Response was measured every other cycle (q 6 weeks) until disease progression is documented.","title":"Response Evaluation Criteria in Solid Tumors Criteria (RECIST) 1.0 Best Response","type":"PRIMARY","unitOfMeasure":"participants"}