{"analyses":[{"ciLowerLimit":"0.504","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.572","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.6879","paramType":"Hazard Ratio (HR)","paramValue":"0.890","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"\\<75% of participants experienced the event within the treatment arm. Hence, third-quartile could not be derived.","groupId":"OG000","lowerLimit":"333.0","upperLimit":"NA","value":"624.0"},{"comment":"\\<50% of participants experienced the event within the treatment arm. Hence, median and third-quartile could not be derived","groupId":"OG001","lowerLimit":"309.00","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"65"}],"units":"Participants"}],"description":"Overall survival is defined as the interval from the first study drug dosing date (or randomization date for participants who did not receive treatment) to death from any cause.","dispersionType":"Inter-Quartile Range","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":"MEDIAN","populationDescription":"ITT Analysis Set. Values are presented based on the Kaplan-Meier analysis. All participants (overall population) were included in analysis.","reportingStatus":"POSTED","timeFrame":"Up to a maximum of 151 weeks","title":"Overall Survival (OS)","type":"SECONDARY","unitOfMeasure":"Days"}