Statement: The difference in Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period in both cohorts of the primary trial is less than 1%.
Primary_evidence: Outcome Measurement:    Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period   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. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.   Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year) Results 1:    Arm/Group Title: Cohort A: SC Herceptin by Needle/Syringe   Arm/Group 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.   Overall Number of Participants Analyzed: 1864   Measure Type: Number   Unit of Measure: percentage of participants  88.6 Results 2:    Arm/Group Title: Cohort B: SC Herceptin by SID   Arm/Group 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.   Overall Number of Participants Analyzed: 709   Measure Type: Number   Unit of Measure: percentage of participants  89.0