{"eventGroups":[{"deathsNumAffected":29,"deathsNumAtRisk":71,"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":"EG000","otherNumAffected":70,"otherNumAtRisk":71,"seriousNumAffected":35,"seriousNumAtRisk":71,"title":"Pralatrexate"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":71,"numEvents":101}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":71,"numEvents":50}],"term":"Neutropenia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":71,"numEvents":8}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":71,"numEvents":13}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":4}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":71,"numEvents":3}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":71,"numEvents":5}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":71,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":71,"numEvents":2}],"term":"Pancytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Hepatic function abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":71,"numEvents":1}],"term":"Liver injury"}],"timeFrame":"AEs were recorded in the eCRF from the point at which the ICF was signed until 30 (± 5) days after the last dose of pralatrexate. This included new AEs that were reported in the 30 (± 5) days after the last dose of pralatrexate."}