{"classes":[{"categories":[{"measurements":[{"comment":"Sample size of 3 patients is too low.","groupId":"OG000","lowerLimit":"1.0","upperLimit":"NA","value":"1.6"},{"comment":"Sample size of 3 patients is too low.","groupId":"OG001","lowerLimit":"2.1","upperLimit":"NA","value":"7.3"},{"groupId":"OG002","lowerLimit":"2.8","upperLimit":"7.4","value":"5.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"33"}],"units":"Participants"}],"description":"Progression is defined as follows:\n\n1. Non-GBM Solid Tumors (Endometrial \\& Ovarian Cancers) - using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) guideline (v.1.1):\n\n   * Target Lesions: \\>/= 20% increase in the sum of the longest diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.\n   * Non-Target Lesions: The appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.\n2. GBM - Using the Response Assessment in Neuro-Oncology (RANO) criteria, any of the criteria below qualify for progression:\n\n   * \\>/= 25% increase in sum of the products of perpendicular diameters of enhancing lesions on stable/increasing dose of corticosteroids\n\n     * Significant increase in T2/FLAIR non-enhancing lesion on stable/increasing dose of corticosteroids\n     * Any new lesion\n     * Clear clinical deterioration not attributable to other cause","dispersionType":"95% Confidence Interval","groups":[{"description":"3 mg/day MLN0128","id":"OG000","title":"Dose Level 1"},{"description":"4 mg/day MLN0128","id":"OG001","title":"Dose Level 2"},{"description":"5 mg/day MLN0128","id":"OG002","title":"Dose Level 3 (MTD)"}],"paramType":"MEDIAN","populationDescription":"* Given the limited sample sizes for Dose Levels 1 \\& 2 (3 patients each), the #s presented here may not be statistically valid.\n* Censoring \\& Final PFS #s: 9 patients treated @ Dose Level 3 were censored from PFS analysis for initiation of new therapy or withdrawal of consent. 2 additional patients treated at Dose Level 3 were censored from PFS analysis because they never had a useable scan on study.","reportingStatus":"POSTED","timeFrame":"Up to 2 years","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"months"}