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In the Follow-Up Period, the following AEs were to be reported: study drug-related serious AEs; AEs of special interest, heart failure, pregnancies, non-breast-related second primary malignancies and deaths, irrespective of causal relationship.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":160,"description":"This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Cross-Over Period of the study.","id":"EG000","otherNumAffected":62,"otherNumAtRisk":160,"seriousNumAffected":6,"seriousNumAtRisk":160,"title":"P+H IV: Treatment Cross-Over Period"},{"deathsNumAffected":0,"deathsNumAtRisk":160,"description":"This safety analysis population includes all participants from Arms A and B who received up to 3 cycles (1 cycle = 21 days) of treatment with the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Cross-Over Period of the study.","id":"EG001","otherNumAffected":84,"otherNumAtRisk":160,"seriousNumAffected":2,"seriousNumAtRisk":160,"title":"PH FDC SC: Treatment Cross-Over Period"},{"deathsNumAffected":0,"deathsNumAtRisk":21,"description":"This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive pertuzumab IV and trastuzumab IV (P+H IV) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).","id":"EG002","otherNumAffected":10,"otherNumAtRisk":21,"seriousNumAffected":0,"seriousNumAtRisk":21,"title":"P+H IV: Treatment Continuation Period"},{"deathsNumAffected":0,"deathsNumAtRisk":138,"description":"This safety analysis population includes all participants from Arms A and B who, following completion of the Treatment Cross-Over Period, chose to receive the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) during the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment).","id":"EG003","otherNumAffected":47,"otherNumAtRisk":138,"seriousNumAffected":4,"seriousNumAtRisk":138,"title":"PH FDC SC: Treatment Continuation Period"},{"deathsNumAffected":0,"deathsNumAtRisk":160,"description":"This safety analysis population includes all participants from Arms A and B who received at least one dose of treatment with pertuzumab IV and trastuzumab IV (P+H IV) and/or the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) across any of the treatment periods during the study from first dose through 28 days after the last dose of study treatment.","id":"EG004","otherNumAffected":125,"otherNumAtRisk":160,"seriousNumAffected":11,"seriousNumAtRisk":160,"title":"All Participants: All Study Treatment Periods"},{"deathsNumAffected":2,"deathsNumAtRisk":159,"description":"This safety analysis population includes all participants from Arms A and B who had received at least one dose of any study treatment and had not discontinued from the study prior to entering the follow-up period. The timeframe of the follow-up period started at 29 days after the last dose of study treatment until the end of follow-up (≥3 years after randomization of the last participant).","id":"EG005","otherNumAffected":2,"otherNumAtRisk":159,"seriousNumAffected":1,"seriousNumAtRisk":159,"title":"Follow-Up Period"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":160,"numEvents":20},{"groupId":"EG001","numAffected":15,"numAtRisk":160,"numEvents":19},{"groupId":"EG002","numAffected":4,"numAtRisk":21,"numEvents":4},{"groupId":"EG003","numAffected":15,"numAtRisk":138,"numEvents":23},{"groupId":"EG004","numAffected":37,"numAtRisk":160,"numEvents":66},{"groupId":"EG005","numAffected":0,"numAtRisk":159,"numEvents":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General 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pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":160,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":160,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":138,"numEvents":1},{"groupId":"EG004","numAffected":12,"numAtRisk":160,"numEvents":12},{"groupId":"EG005","numAffected":1,"numAtRisk":159,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 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infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":160,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":160,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":138,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":160,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":159,"numEvents":0}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":160,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":160,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":138,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":160,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":159,"numEvents":0}],"term":"Asthma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 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reporting timeframes during study treatment: Cross-Over Period: 3 cycles (cyc) of P+H IV & 3 cyc of PH FDC SC; Continuation Period: from Cyc 7 to 18 total cyc of P+H IV or PH FDC SC (1 cyc = 21 days); All Participants: from first dose through 28 days after last dose of study treatment (up to 1 year). Follow-up period: AEs reported from 29 days up to 7 months after the last dose of study treatment; deaths reported from 29 days after last dose until the end of follow-up (≥3 years)."}