{"analyses":[{"ciLowerLimit":"0.04","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.77","estimateComment":"An odds ratio (OR) \\<1 represents lower odds of loss of response under treatment with relacorilant compared with treatment with placebo.","groupDescription":"A logistic regression model with logit link function was used in order to detect if there was a significant difference in total number of patients with a loss of response with respect to HTN under treatment with relacorilant compared with treatment with placebo in the RW Phase.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Log odds is equal to 0 (null hypothesis) vs log odds not equal to 0 (alternative hypothesis).","nonInferiorityType":"EQUIVALENCE","pValue":"0.0215","paramType":"Odds Ratio (OR)","paramValue":"0.17","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}],"title":"SBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"DBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"}]}],"title":"SBP and/or DBP"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"7"}]}],"title":"Use of rescue medication"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Treatment discontinuation"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"}]}],"title":"Missing ABPM at end of RW Phase"}],"denoms":[{"counts":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"description":"Loss of response with respect to HTN was measured using 6 criteria: 1) an increase in SBP of at least 5 mm Hg, 2) an increase in DBP of at least 5 mm Hg, 3) an increase in SBP and/or DBP of at least 5 mm Hg, 4) use of HTN rescue medication, 5) treatment discontinuation, and 6) missing 24-hour ambulatory blood pressure monitoring (ABPM) measurement at the end of the RW Phase. Blood pressure was measured using ABPM. Use of rescue medication was defined as any increase, modification, or addition of antihypertensive medication due to worsening HTN. Treatment discontinuation reports the number of patients who discontinued study treatment in the RW Phase for any reason.","groups":[{"description":"Patients who meet any of the response criteria will advance to the RW Phase of the study and receive the same dose of relacorilant as the last dose administered in the OL Phase.\n\nRelacorilant: Relacorilant is supplied as 100 mg capsules for oral dosing.","id":"OG000","title":"Relacorilant (RW Phase)"},{"description":"Patients who meet any of the response criteria will advance to the RW Phase of the study and receive placebo matched to study drug.\n\nPlacebo: Placebo matched to study drug.","id":"OG001","title":"Placebo (RW Phase)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The analysis population was patients in the Intent-to-Treat (ITT-RW) Population who met the HTN response criteria at conclusion of the OL Phase. The ITT-RW Population included all patients who were randomized in the RW Phase and received at least 1 dose of study drug post randomization.","reportingStatus":"POSTED","timeFrame":"Week 22 (end of OL Phase) and Week 36 (Week 12 of RW Phase)","title":"Number of Patients With Loss of Response With Respect to Hypertension During the RW Phase.","type":"PRIMARY","unitOfMeasure":"Participants"}