{"analyses":[{"ciLowerLimit":"0.51","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.85","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"0.66"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"71","upperLimit":"106","value":"87.6"},{"groupId":"OG001","lowerLimit":"46","upperLimit":"64","value":"54.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"233"}],"units":"Participants"}],"description":"Duration of objective response (estimated using the Kaplan-Meier method) was defined as the time from the initial confirmed complete response (CR) or partial response (PR), the date of tumor assessment at which the CR/PR was first detected by the independent review facility (IRF) using RECIST version 1.0, until the date of IRF-determined progressive disease (PD), death from any cause within 18 weeks of the last tumor assessment, or first administration of next line of anti-cancer therapy (whichever occurred first). If the visit when the initial CR or PR was observed spanned multiple dates, the latest date was used. Only participants in the ITT analysis population with an IRF-determined objective response (CR or PR), observed prior to IRF-assessed PD, death or next line of anti-cancer therapy, were included in the analysis. Participants who did not progress or die after they had a confirmed response were censored at the date of their last IRF-evaluable tumor measurement.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants randomized to this arm received pertuzumab 420 milligrams (mg) intravenously (IV) once every 3 weeks (q3w) and trastuzumab 6 milligrams per kilogram (mg/kg) IV q3w, plus docetaxel 75 milligrams per square metre of body surface (mg/m\\^2) IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG000","title":"Pertuzumab + Trastuzumab + Docetaxel"},{"description":"Participants randomized to this arm received placebo IV q3w and trastuzumab 6 mg/kg IV q3w, plus docetaxel 75 mg/m\\^2 IV q3w (for at least 6 cycles; 1 cycle was 21 days). After Cycle 6, continuation of docetaxel treatment was at the discretion of the participant and treating physician. Participants remained in the treatment phase of the study until investigator-assessed radiographic or clinical evidence of disease progression, unmanageable toxicity, or study termination and were followed for survival until death, loss to follow-up, withdrawal of consent, or study termination.","id":"OG001","title":"Placebo + Trastuzumab + Docetaxel"}],"paramType":"MEDIAN","populationDescription":"ITT Population: All randomized participants; only participants with IRF-determined measurable disease at baseline (i.e., ≥1 target lesion) that had an objective response were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From initial IRF-confirmed objective response until IRF-determined progressive disease (PD), death, or first administration of next line of anti-cancer therapy (whichever occurred first), up to the primary completion date (up to 3 years, 3 months)","title":"Duration of Objective Response Determined by an Independent Review Facility","type":"SECONDARY","unitOfMeasure":"Weeks"}