{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"94.7"},{"groupId":"OG001","value":"86.7"}]}],"title":"Comfortable"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"100"}]}],"title":"Convenient"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"100"}]}],"title":"Confident"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"93.3"}]}],"title":"Satisfied"},{"categories":[{"measurements":[{"groupId":"OG000","value":"100"},{"groupId":"OG001","value":"93.3"}]}],"title":"Would Use Again"}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"description":"Participants who performed self-administration of SC Herceptin via SID were given an evaluation questionnaire during the continuation period (Weeks 25 to 52) after their first self-administration. Participants responded to 5 statements about their comfort with self-injection, the convenience of the SID, their self-confidence using the SID, their satisfaction with the SID, and whether they would consider using the SID again in the future. Each statement used a 5-item rating scale with responses from \"Strongly Disagree\" to \"Strongly Agree\". The percentage of participants with a positive response (either \"Agree\" or \"Strongly Agree\") to each questionnaire statement was reported.","groups":[{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. 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. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.","id":"OG000","title":"Cohort 1: SC (SID) Then IV Herceptin"},{"description":"Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. 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. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.","id":"OG001","title":"Cohort 1: IV Then SC (SID) Herceptin"}],"paramType":"NUMBER","populationDescription":"Safety Population. The \"Number of Participants Analyzed\" reflects those who self-administered SC Herceptin using the SID and completed the SC SID questionnaire. Results were planned to be analyzed for only Cohort 1 because the objective of the study was to evaluate satisfaction among those who self-administered the SID formulation of Herceptin.","reportingStatus":"POSTED","timeFrame":"Immediately following first self-administration of SC Herceptin via SID (once during Weeks 25 to 52)","title":"Percentage of Participants With Responses of \"Agree\" or \"Strongly Agree\" on the SC SID Satisfaction Questionnaire","type":"SECONDARY","unitOfMeasure":"percentage of participants"}