{"analyses":[{"ciLowerLimit":"27.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"56.8","groupDescription":"Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.001","pValueComment":"P-value was stratified by baseline disease diagnosis (pcALCL and MF).","paramType":"Risk Difference (RD)","paramValue":"42.2","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.5","upperLimit":"66.9","value":"54.7"},{"groupId":"OG001","lowerLimit":"4.4","upperLimit":"20.6","value":"12.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"64"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"description":"ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).","dispersionType":"95% Confidence Interval","groups":[{"description":"Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).","id":"OG000","title":"Brentuximab Vedotin"},{"description":"Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m\\^2, tablets, orally, once daily with meals for up to 48 weeks.","id":"OG001","title":"Methotrexate or Bexarotene"}],"paramType":"NUMBER","populationDescription":"The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.","reportingStatus":"POSTED","timeFrame":"Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)","title":"Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)","type":"PRIMARY","unitOfMeasure":"percentage of participants"}