{"groups":[{"description":"Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.","id":"FG000","title":"Cohort A: SC Herceptin by Needle/Syringe"},{"description":"Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.","id":"FG001","title":"Cohort B: SC Herceptin by Single-Use Injection Device (SID)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"35"},{"groupId":"FG001","numSubjects":"9"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"13"}],"type":"Disease Progression/Recurrence"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"}],"type":"Investigator/Sponsor Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"}],"type":"Lack of Compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"100"},{"groupId":"FG001","numSubjects":"30"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Pregnancy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"1867"},{"groupId":"FG001","numSubjects":"710"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1670"},{"groupId":"FG001","numSubjects":"652"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"197"},{"groupId":"FG001","numSubjects":"58"}],"type":"NOT COMPLETED"}],"title":"Treatment Period"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"48"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"155"},{"groupId":"FG001","numSubjects":"49"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"4"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"}],"type":"Non-compliance"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}],"type":"Site closure"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"}],"type":"Erroneous reporting or late reporting"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Missing"},{"reasons":[{"groupId":"FG000","numSubjects":"223"},{"groupId":"FG001","numSubjects":"90"}],"type":"Disease progression /disease recurrence"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Sponsor decision"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"comment":"Participants who discontinued treatment were allowed to join the SFU Period.","groupId":"FG000","numSubjects":"1865"},{"comment":"Participants who discontinued treatment were allowed to join the SFU Period.","groupId":"FG001","numSubjects":"708"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"1318"},{"groupId":"FG001","numSubjects":"501"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"547"},{"groupId":"FG001","numSubjects":"207"}],"type":"NOT COMPLETED"}],"title":"Safety Follow-up"}],"preAssignmentDetails":"Of the 2984 participants screened, a total of 2577 participants were enrolled into the trial, and 2573 participants received at least one dose of study treatment.\n\n4 Participants were not included in the Safety Follow-Up (SFU) ITT due to the lack of Principal Investigator signatures."}