{"analyses":[{"ciLowerLimit":"-10.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-2.43","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0014","paramType":"Least Squares Mean Difference","paramValue":"-6.22","statisticalMethod":"mixed model for repeated measures (MMRM)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.08","value":"-9.36"},{"groupId":"OG001","spread":"1.62","value":"-3.13"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"description":"TSS was measured using the MFSAF v4.0. The MFSAF v4.0 comprises 7 domains representing the 7 most relevant symptoms of MF identified through existing participant and clinician-based evidence: fatigue, night sweats, pruritus, abdominal discomfort, pain under the left ribs, early satiety, and bone pain. Participants scored each symptom domain using an 11-point numeric rating scale ranging from 0 (absent) to 10 (worst imaginable). The MFSAF TSS was calculated as the sum of scores of the 7 domains for a possible range of scores of 0 to 70, with a higher TSS corresponding to more severe symptoms. A reduction from Baseline corresponded to a lessening of MF symptoms. Baseline was the last assessment done before or on the day of first dose date. Change from Baseline was defined as the post-Baseline value minus Baseline value.","dispersionType":"Standard Error","groups":[{"description":"Participants were randomized to receive 200 milligrams (mg) of MMB orally QD and a DAN-placebo orally twice daily (BID) during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants continued to receive 200 mg of MMB orally QD during the open-label extended treatment period. Participants who discontinued treatment prior to Week 24 due to splenic progression or other reasons, but completed assessments, were unblinded. Participants who discontinued MMB during the randomized treatment period were not eligible to receive MMB in the open-label extended treatment period. Participants who were randomized to MMB during the randomized treatment period with confirmed splenic progression could not proceed to the open-label extended treatment period.","id":"OG000","title":"MMB 200 mg QD + Placebo"},{"description":"Participants were randomized to receive 300 mg of DAN orally BID and MMB-placebo orally QD during the randomized 24-week double-blind treatment period. Participants who completed the randomized treatment period, discontinued treatment early due to splenic progression, or discontinued treatment early for other reasons but completed scheduled assessments through Week 24 were enrolled in an open-label extended treatment period. Participants who received DAN 300 mg BID during randomized period switched to receive 200 mg of MMB orally QD during open-label extended treatment period.","id":"OG001","title":"DAN 300 mg BID + Placebo"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"ITT Analysis Set. Only those participants with data available at specified time points were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 24","title":"Change From Baseline in MFSAF TSS at Week 24","type":"SECONDARY","unitOfMeasure":"Scores on a scale"}