{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1690.6","upperLimit":"1750.2","value":"1720.2"},{"groupId":"OG001","lowerLimit":"1184.9","upperLimit":"1221.3","value":"1203.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"9062"},{"groupId":"OG001","value":"11908"}],"units":"Adverse Events"}],"title":"All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"214.7","upperLimit":"236.4","value":"225.3"},{"groupId":"OG001","lowerLimit":"125.8","upperLimit":"137.9","value":"131.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"1187"},{"groupId":"OG001","value":"1304"}],"units":"Adverse Events"}],"title":"Grades 3 to 5"}],"denomUnitsSelected":"Adverse Events","denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"}],"units":"Participants"},{"counts":[{"groupId":"OG000","value":"9062"},{"groupId":"OG001","value":"11908"}],"units":"Adverse Events"}],"description":"Adverse event (AE) severity, including serious and non-serious AEs, was assessed according to the NCI-CTCAE version 3.0; if the AE was not specifically listed, the following grades of severity were used: Grade 1 is mild; Grade 2 is moderate; Grade 3 is severe; Grade 4 is life-threatening or disabling; and Grade 5 is death. Multiple occurrences of the same AE in 1 participant were counted multiple times. Only AEs that started during the overall study treatment period were included. The cutoff date for inclusion of events and for calculation of patient-years was the date of the most recent follow-up of the participant, defined as the last available date during the treatment period, excluding pre-treatment and safety follow-up data. Confidence intervals were calculated assuming the number of events followed a Poisson distribution. Data reported prior to the date of first crossover treatment were included under the Placebo arm for participants who crossed over from placebo to pertuzumab.","dispersionType":"90% Confidence Interval","groups":[{"description":"This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants received placebo IV q3w and trastuzumab 6 mg/kg IV q3This is the placebo safety population, which includes participants who received study treatment with placebo at every cycle. Participants 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":"OG000","title":"Placebo + Trastuzumab + Docetaxel"},{"description":"This is the pertuzumab safety population, which includes participants who received at least one dose of study treatment with pertuzumab. Participants 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":"OG001","title":"Pertuzumab + Trastuzumab + Docetaxel"}],"paramType":"NUMBER","populationDescription":"Safety Population: All participants who received at least one dose of any study medication.","reportingStatus":"POSTED","timeFrame":"From Baseline to 42 days after the last dose of study treatment (total patient-years of exposure on study treatment in Placebo vs. Pertuzumab arms: 526.81 vs. 989.88 patient-years)","title":"Overall Number of Adverse Events by Severity (NCI-CTCAE v3.0 All Grades and Grades 3 to 5) Per 100 Patient-Years of Exposure During the Treatment Period","type":"SECONDARY","typeUnitsAnalyzed":"Adverse Events","unitOfMeasure":"Events per 100 patient-years"}