{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"6"}]}],"title":"Participants with Any Treatment Emergent AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"2"}]}],"title":"Participants with Any Grade 3 - 4 AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Participants with Treatment Emergent AEs Resulting in Deaths"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"0"}]}],"title":"Participants with Treatment Emergent SAEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"}]}],"title":"Participants with Any SAEs Leading to Drug Discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"Hematology:Higher Than Grade 3/4 Lab Abnormalities"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}],"title":"Chemistry:Higher Than Grade 3/4 Lab Abnormalities"}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"7"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. AE included both serious and non- SAEs. An AE of \"Hematology and Chemistry\" was collected and graded as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03, where Grade 3 refers to severe or medically significant but not immediately life threatening and Grade 4 refers to life-threatening consequences.","groups":[{"description":"Participants randomized to Pralatrexate Arm received pralatrexate as an intravenous (IV) push administered over a minimum of 30 seconds up to a maximum of 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride \\[NaCl\\]) weekly for 3 weeks of a 4-week cycle. Initial dose of pralatrexate was 30 milligram per meter square (mg/m\\^2), could be reduced to 20 mg/m\\^2 with potential further reductions to 15 and 10 mg/m\\^2 based on toxicity, along with vitamin B12, 1 milligram (mg) intramuscular (IM), every 8-10 weeks and folic acid 1-1.25 mg by mouth (po) once a day (qd) until a criterion for study treatment discontinuation was met or up to a maximum of 2 years.","id":"OG000","title":"Pralatrexate Arm"},{"description":"Participants randomized to Observation Arm received vitamin B12, 1 mg, IM every 8-10 weeks and folic acid 1-1.25 mg by mouth qd remained under observation, by attending clinic visits every 4 weeks, and being contacted by a healthcare professional during week 2 of every 4-week period until a criterion for study treatment discontinuation was met.","id":"OG001","title":"Observation Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety population included all randomized participants classified according to the actual study treatment received, regardless of random assignment.","reportingStatus":"POSTED","timeFrame":"From first dose of study drug to 35 (±5) days after last dose of study drug for the Pralatrexate Arm, and until 35 (± 5) days after the study treatment discontinuation for the Observation Arm (Up to 2 years)","title":"Number of Participants With Worst Grade Adverse Events (AEs), Deaths, Serious Adverse Events (SAEs), and SAEs Leading to Discontinuation of Study Treatment, and Worst Grade Laboratory Abnormalities","type":"SECONDARY","unitOfMeasure":"Participants"}