{"analyses":[{"groupDescription":"The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.","groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.001","statisticalMethod":"Clopper-Pearson exact method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"65.6","upperLimit":"86.3","value":"77.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"70"}],"units":"Participants"}],"description":"The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission \\[CR\\] + complete remission with incomplete marrow recovery \\[CRi\\] + nodular partial remission \\[nPR\\] + partial remission \\[PR\\]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.","id":"OG000","title":"Main Cohort"}],"paramType":"NUMBER","populationDescription":"The first 70 participants who were treated with ABT-199 in the Main Cohort","reportingStatus":"POSTED","timeFrame":"Up to 36 weeks","title":"Overall Response Rate (Main Cohort)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}