{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"116"},{"groupId":"OG001","value":"160"},{"groupId":"OG002","value":"10"}]}],"title":"At Least One Serious AE - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"386"},{"groupId":"OG001","value":"400"},{"groupId":"OG002","value":"45"}]}],"title":"At Least One Non-Serious AE - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"391"},{"groupId":"OG001","value":"408"},{"groupId":"OG002","value":"47"}]}],"title":"At Least One AE - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"368"},{"groupId":"OG001","value":"386"},{"groupId":"OG002","value":"44"}]}],"title":"At Least One AE - Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"350"},{"groupId":"OG001","value":"383"},{"groupId":"OG002","value":"34"}]}],"title":"At Least One AE - Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"229"},{"groupId":"OG001","value":"264"},{"groupId":"OG002","value":"11"}]}],"title":"At Least One AE - Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"158"},{"groupId":"OG001","value":"167"},{"groupId":"OG002","value":"1"}]}],"title":"At Least One AE - Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"1"}]}],"title":"At Least One AE - Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"description":"Adverse event (AE) severity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0); if the AE was not specifically listed, the following grades of severity were used: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening or disabling; and Grade 5 = death. Severe and serious are not synonymous. Severity refers to the intensity of an AE, whereas a serious AE must meet criteria set out in the protocol; both were independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of the same AE in one participant. AEs reported prior to first crossover treatment were included in the Placebo arm, and in the Crossover arm after that date, for participants who crossed over from placebo to pertuzumab. Median \\[range\\] time on study treatment per arm: Placebo: 49.3 \\[0.3-514.7\\] weeks; Pertuzumab: 75.7 \\[0.6-519.6\\] weeks; Crossover: 129.9 \\[0.3-322.3\\] weeks.","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 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"},{"description":"Fifty of 406 participants (12.3%) randomized to the placebo treatment arm whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2018. Participants received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol. 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":"OG002","title":"Crossover From Placebo to Pertuzumab"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population: All participants who received at least one dose of any study medication.","reportingStatus":"POSTED","timeFrame":"Placebo arm: Baseline to last dose of study treatment +42 days (or crossover date); Pertuzumab arm: Baseline to last dose of study treatment +42 days; Crossover arm: Crossover date to last dose of study treatment +42 days (see Description - time per arm)","title":"Overall Number of Participants Who Experienced at Least One Adverse Event, Including Serious and Non-Serious Adverse Events, by Most Severe Intensity (According to NCI-CTCAE v3.0) During the Treatment Period","type":"SECONDARY","unitOfMeasure":"Participants"}