{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"22.1","upperLimit":"26.0","value":"24.0"},{"groupId":"OG001","lowerLimit":"18.1","upperLimit":"24.2","value":"21.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"1864"},{"groupId":"OG001","value":"709"}],"units":"Participants"}],"description":"Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.","dispersionType":"95% Confidence Interval","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":"OG000","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 an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.","id":"OG001","title":"Cohort B: SC Herceptin by SID"}],"paramType":"NUMBER","populationDescription":"Safety Population","reportingStatus":"POSTED","timeFrame":"From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)","title":"Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period","type":"PRIMARY","unitOfMeasure":"percentage of participants"}