{"analyses":[{"ciLowerLimit":"6.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.4","estimateComment":"The 95% CI for the difference in objective response rate (Trastuzumab emtansine minus Lapatinib + Capecitabine) was computed by using the approximate normal method.","groupDescription":"Analysis stratified by region of enrollment, number of prior chemotherapeutic regimens (0-1 or \\>1), and visceral/ non-visceral disease.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0002","paramType":"Difference in Objective Response Rates","paramValue":"12.7","statisticalMethod":"Mantel-Haenszel chi-squared test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"38.6","upperLimit":"48.6","value":"43.6"},{"groupId":"OG001","lowerLimit":"26.3","upperLimit":"35.7","value":"30.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"397"},{"groupId":"OG001","value":"389"}],"units":"Participants"}],"description":"Tumor response was assessed by an IRC according to modified RECIST. OR was defined as the percentage of participants with a complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 5 per organ and 10 in total were identified as TLs and recorded at baseline. A sum of the longest diameter for all TLs was calculated as baseline SLD. For TLs, a CR was defined as the disappearance of all TLs and a PR was defined as \\>/= 30% decrease in the SLD of TLs, taking as reference the baseline SLD. For non-TLs, a CR was defined as the disappearance of all non-TLs and a PR was defined as the persistence of 1 or more non-TLs. Confirmation of response at a consecutive tumor assessment at least 4 weeks apart was required. Participants without a post-baseline tumor assessment were considered non-responders. The percentage of participants with CR or PR by IRC was reported. The 95% CI was computed using Blyth-Still Casella exact CI method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.","id":"OG000","title":"Trastuzumab Emtansine"},{"description":"Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.","id":"OG001","title":"Lapatinib + Capecitabine"}],"paramType":"NUMBER","populationDescription":"ITT population included all randomized participants on the basis of the treatment assigned at randomization. Only participants with measurable disease at baseline were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months)","title":"Percentage of Participants With Objective Response (OR) as Assessed by an IRC","type":"SECONDARY","unitOfMeasure":"percentage of participants"}