{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.76","statisticalComment":"1- degree of freedom (1-df) likelihood ratio test (LRT) in a cell dose stratified Cox model","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"78.2","upperLimit":"96.7","value":"91.3"},{"groupId":"OG001","lowerLimit":"78.6","upperLimit":"97.6","value":"92.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"47"}],"units":"Participants"}],"description":"A progressive response is defined as follows:\n\nIncrease of \\> 25% from lowest response value in any one or more of the following:\n\nSerum M-component and/or (the absolute increase must be \\> 0.5 g/dL)6 Urine M-component and/or (the absolute increase must be \\> 200 mg/24 h) Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \\> 10 mg/dL Bone marrow plasma cell percentage; the absolute percentage must be \\> 10%7 Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas Development of hypercalcaemia (corrected serum calcium \\> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder\n\nAnyone who did not have a progressive response was considered as progression free survival.","dispersionType":"95% Confidence Interval","groups":[{"description":"Subjects on the experimental arm will receive 90 minutes of hyperbaric oxygen therapy approximately six hours prior to hematopoietic stem cell infusion.\n\nHyperbaric Oxygen Therapy: The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).","id":"OG000","title":"Hyperbaric Oxygen Therapy"},{"description":"Subjects on the reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell infusion.\n\nNo Hyperbaric Oxygen Therapy: The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.","id":"OG001","title":"No Hyperbaric Oxygen Therapy"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"1 year","title":"Percentage of Participants With Progressive Free Survival","type":"SECONDARY","unitOfMeasure":"percentage of participants"}