{"description":"Analysis Population Description: Safety Population","eventGroups":[{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.","id":"EG000","otherNumAffected":81,"otherNumAtRisk":242,"seriousNumAffected":4,"seriousNumAtRisk":242,"title":"Cohort 1: SC (SID) Herceptin (Crossover)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.","id":"EG001","otherNumAffected":55,"otherNumAtRisk":241,"seriousNumAffected":2,"seriousNumAtRisk":241,"title":"Cohort 1: IV Herceptin (Crossover)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.","id":"EG002","otherNumAffected":46,"otherNumAtRisk":226,"seriousNumAffected":6,"seriousNumAtRisk":226,"title":"Cohort 1: IV Herceptin (Continuation)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.","id":"EG003","otherNumAffected":7,"otherNumAtRisk":43,"seriousNumAffected":1,"seriousNumAtRisk":43,"title":"Cohort 1: SC (SID) Herceptin (Continuation)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.","id":"EG004","otherNumAffected":130,"otherNumAtRisk":244,"seriousNumAffected":12,"seriousNumAtRisk":244,"title":"Cohort 1 Overall: SC (SID) and IV Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.","id":"EG005","otherNumAffected":107,"otherNumAtRisk":237,"seriousNumAffected":0,"seriousNumAtRisk":237,"title":"Cohort 2: SC (Vial) Herceptin (Crossover)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.","id":"EG006","otherNumAffected":76,"otherNumAtRisk":237,"seriousNumAffected":2,"seriousNumAtRisk":237,"title":"Cohort 2: IV Herceptin (Crossover)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.","id":"EG007","otherNumAffected":6,"otherNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"title":"Cohort 2: IV Herceptin (Continuation)"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. 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