{"analyses":[{"ciLowerLimit":"-7.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.53","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.736","paramType":"Difference in Percentage","paramValue":"-1.3","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.19","upperLimit":"19.62","value":"15.05"},{"groupId":"OG001","lowerLimit":"12.38","upperLimit":"21.08","value":"16.39"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"299"}],"units":"Participants"}],"description":"LCSS-Meso provides participant-reported outcome measures of symptom burden and quality of life. LCSS-Meso includes the disease-related item dyspnea or shortness of breath. The LCSS-Meso item dyspnea is measured on a visual analog scale (VAS) using 100 mm and assigned an individual score based on symptom intensity. Dyspnea VAS score ranges from 0 mm (lowest; no dyspnea) to 100 mm (highest; worst dyspnea). Higher scores indicate dyspnea worsening. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥50% change (percent change calculated: \\[Week 12 - Baseline\\]/Baseline\\*100) and \\>10 mm absolute change in LCSS-Meso dyspnea score from baseline to Week 12 post treatment initiation is reported here for all randomized participants who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.","dispersionType":"95% Confidence Interval","groups":[{"description":"Vorinostat three 100 mg capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.","id":"OG000","title":"Vorinostat"},{"description":"Placebo capsules twice daily for 3 consecutive days of treatment followed by 4 days of rest repeated weekly, in 21-day cycles. Treatment continued until disease progression or unacceptable toxicity.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"All participants randomized to a study arm who had a valid baseline and ≥1 post-baseline value for the LCSS-Meso dyspnea score available.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 12","title":"Percentage of Participants With ≥50% Change Together With a >10 mm Change From Baseline in the LCSS-Meso Dyspnea Score at Week 12","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}