{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"}],"units":"Participants"}],"description":"An SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.","groups":[{"description":"For patients who are \\< 60 years.\n\n* Melphalan: 140 mg/m2/day IV on Day: -6\n* Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = \\[(140-age) x weight (kg) x 0.85 (for women only)\\]/ \\[72 x creat (mg/dl)\\].)\n* TBI: 200 cGy Day: -1.\n\nFor patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \\>3 (at the discretion of treating physician will have an option to receive):\n\n* Melphalan: 70 mg/m2/day IV on Day -6.\n* Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2.\n* TBI: 200 cGy; Days -1.\n\nEvomela: 140 mg/m\\^2/day IV on Day -6 for patients who are \\< 60 years of age. 70 mg/m\\^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of \\>3\n\nFludarabine: 40 mg/ m\\^2/day intravenous on Days: -5 -4, -3, -2\n\nTotal Body Irradiation: 200 cGy on Day: -1\n\nHaploidentical Hematopoietic Cell Transplantation: This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.","id":"OG000","title":"MEL/FLU and Total-Body Irradiation (TBI)"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"2 Years","title":"Serious Adverse Events (SAE).","type":"PRIMARY","unitOfMeasure":"Participants"}