{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"280"},{"groupId":"OG002","value":"25"}]}],"title":"Diarrhoea (HLT+PT) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"1"}]}],"title":"Diarrhoea (HLT+PT) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"155"},{"groupId":"OG001","value":"213"},{"groupId":"OG002","value":"18"}]}],"title":"Rash (AEGT) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"0"}]}],"title":"Rash (AEGT) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"231"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"1"}]}],"title":"Leukopenia (SMQ-narrow) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"211"},{"groupId":"OG001","value":"238"},{"groupId":"OG002","value":"0"}]}],"title":"Leukopenia (SMQ-narrow) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"53"},{"groupId":"OG002","value":"0"}]}],"title":"Leukopenic Infection (PTs) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"0"}]}],"title":"Leukopenic Infection (PTs) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"0"}]}],"title":"Febrile Neutropenic Infection (PTs) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"0"}]}],"title":"Febrile Neutropenic Infection (PTs) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"48"},{"groupId":"OG002","value":"1"}]}],"title":"Anaphylaxis and Hypersensitivity (AEGT)-All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"0"}]}],"title":"Anaphylaxis and Hypersensitivity (AEGT)-Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"1"}]}],"title":"Interstitial Lung Disease (SMQ-narrow) -All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"0"}]}],"title":"Interstitial Lung Disease (SMQ-narrow) -Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"0"}]}],"title":"QT Prolongation (SMQ-wide) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}]}],"title":"QT Prolongation (SMQ-wide) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"208"},{"groupId":"OG002","value":"12"}]}],"title":"Mucositis (AEGT) - All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"0"}]}],"title":"Mucositis (AEGT) - Grade ≥3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"0"}]}],"title":"Drug-Related Hepatic Disorder(SMQ-wide)-All Grades"},{"categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"0"}]}],"title":"Drug-Related Hepatic Disorder (SMQ-wide)-Grade ≥3"}],"denoms":[{"counts":[{"groupId":"OG000","value":"396"},{"groupId":"OG001","value":"408"},{"groupId":"OG002","value":"50"}],"units":"Participants"}],"description":"The clinical diagnoses listed in this table, excluding cardiac safety (summarized separately), were also selected as adverse events (AEs) to monitor based on clinical and nonclinical data for pertuzumab and the safety profile established for trastuzumab, monoclonal antibodies in general, and potential effects associated with HER receptor inhibition. Search strategies were defined by single or aggregate MedDRA Preferred Terms (PT) through Standardized MedDRA Queries (SMQ), where possible, or based on Roche AE Group Terms (AEGT). Diarrhoea AEs: High-Level Term (HLT) 'Diarrhoea (excl. infective)' and PT 'Diarrhoea infectious'. Leukopenic and Febrile Neutropenic Infections: AEs from 'Infections \\& Infestations' with start ≤14 days after start date of Grade ≥3 AEs in SMQ(narrow) 'Leukopenia' or PT 'Febrile neutropenia', respectively. 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 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"},{"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":"Number of Participants Who Experienced at Least One Adverse Event to Monitor (Excluding Cardiac-Related AEs) by Severity During the Treatment Period","type":"SECONDARY","unitOfMeasure":"Participants"}