{"classes":[{"categories":[{"measurements":[{"comment":"This analysis is based on cut off data, there are no enough events to estimated upper limit of 95% CI of median OS.","groupId":"OG000","lowerLimit":"10.35","upperLimit":"NA","value":"18.00"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"}],"units":"Participants"}],"description":"OS was measured from treatment day 1 until death or censoring.","dispersionType":"95% Confidence Interval","groups":[{"description":"Vitamin B12 and folic acid will be taken concurrently with pralatrexate\n\npralatrexate: Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.\n\nVitamin B12 and folic acid: The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.","id":"OG000","title":"Pralatrexate"}],"paramType":"MEDIAN","populationDescription":"The secondary analyses was performed using the safety population and repeated using the per-protocol population.","reportingStatus":"POSTED","timeFrame":"4 years","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"months"}