{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"}],"units":"Participants"}],"description":"To determine the safety profile of propylene glycol-free melphalan hydrochloride in the conditioning regimen prior to autologous stem cell transplantation in AL amyloidosis patients, including adverse events related to renal dysfunction (was acute renal failure is defined as either a \\>/=1 mg/dL increase in serum creatinine or a doubling of serum creatinine to \\>/=1.5 mg/dL for at least 2 days.).","groups":[{"description":"Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation\n\nPropylene Glycol-Free Melphalan Hydrochloride: Intravenous Propylene Glycol-Free Melphalan Hydrochloride","id":"OG000","title":"Evomela"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"100 days","title":"Number of Participants With Renal Dysfunction","type":"PRIMARY","unitOfMeasure":"Participants"}