{"analyses":[{"ciLowerLimit":"-4.97","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"11.17","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.488","paramType":"Difference in Percentage","paramValue":"3.1","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"19.08","upperLimit":"31.17","value":"24.76"},{"groupId":"OG001","lowerLimit":"16.24","upperLimit":"27.86","value":"21.63"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"210"},{"groupId":"OG001","value":"208"}],"units":"Participants"}],"description":"Pulmonary function test was conducted using a spirometer for assessment of FVC. FVC is the volume of air forcibly exhaled from the lungs after taking the deepest breath possible. Baseline measurement was taken before treatment initiation. Per protocol percentage of participants with ≥10% change (percent change calculated: \\[Week 12 - Baseline\\]/Baseline\\*100) in FVC 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 FVC.","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 FVC available.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 12","title":"Percentage of Participants With ≥10% Change From Baseline in FVC at Week 12","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}