{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30"}],"title":"0 Alopecia"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"1 Level"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"2 Level"}],"title":"Screening"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"}],"title":"1 Level"},{"measurements":[{"groupId":"OG000","value":"26"}],"title":"0 Alopecia"},{"measurements":[{"groupId":"OG000","value":"0"}],"title":"2 Level"}],"title":"Day 30"}],"denoms":[{"counts":[{"groupId":"OG000","value":"30"}],"units":"Participants"}],"description":"Change in development of hair loss will be defined as \\< 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated. In CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, alopecia is graded based on the extent of hair loss, with two main grades: Grade 1 (hair loss less than 50%, not obvious from a distance) and Grade 2 (hair loss of 50% or more, readily apparent). Grade 1 alopecia may be manageable with different hairstyles, while Grade 2 typically requires a wig or other camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported","groups":[{"description":"Patients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.\n\nPenguin Cold Cap: Penguin cold cap: administered 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.","id":"OG000","title":"Penguin Cold Cap"}],"paramType":"COUNT_OF_PARTICIPANTS","reportingStatus":"POSTED","timeFrame":"Screening (Day 0), Day 30","title":"Change in Development of Hair Loss","type":"PRIMARY","unitOfMeasure":"Participants"}