{"analyses":[{"ciLowerLimit":"-1.18","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.97","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.621","paramType":"Difference in Percentage","paramValue":"0.3","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.08","upperLimit":"2.25","value":"0.63"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"1.71","value":"0.31"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"318"},{"groupId":"OG001","value":"323"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who had a complete response (CR: disappearance of all target lesions with no evidence of tumor elsewhere) or a partial response (PR: ≥30% reduction in the total tumor measurement) per Meso-modified RECIST based on independent radiology review. Meso-modified RECIST was created and validated for disease measurement in pleural mesothelioma. The final analysis for ORR per Meso-modified RECIST by independent radiology review was planned and performed at the time of the protocol pre-specified final statistical analysis with a data cut-off of 15-July-2011. Per protocol percentage of participants who had a CR or a PR per Meso-modified RECIST by independent radiology review is reported here as the ORR for all randomized participants who had valid baseline data for ORR analysis 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 valid baseline data for ORR analysis available.","reportingStatus":"POSTED","timeFrame":"Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011)","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}