{"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":"FG000","title":"Pralatrexate"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"36"}],"type":"Progression of Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"11"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"6"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"5"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Conditions interfere with participation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"3-week lapse between pralatrexate doses"},{"reasons":[{"groupId":"FG000","numSubjects":"8"}],"type":"Patients in treatment less than 24 month"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"71"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"71"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"In the protocol, 85 patients are planned to enroll. However, 71 patients are treated in the real situation."}