NCT01566721 · OUTCOME

Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period

A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer · Source last updated 2021-04-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: percentage of participants
Interval / dispersion: Not reported
Time frame: From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

What was measured

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.

Analysis population: Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.

Groups in this outcome

Cohort A: SC Herceptin by Needle/Syringe

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.

Cohort B: SC Herceptin by SID

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Cohort A: SC Herceptin by Needle/Syringe	1864
Cohort B: SC Herceptin by SID	709

Reported measurements

Source class 1

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort A: SC Herceptin by Needle/Syringe	88.6	Not reported	Not reported	Not reported	Not reported
Cohort B: SC Herceptin by SID	89.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
88.6
group Id
OG001
value
89.0

denoms

counts
group Id
OG000
value
1864
group Id
OG001
value
709
units
Participants

description

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

param Type

NUMBER

population Description

Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.

reporting Status

POSTED

time Frame

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

title

Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period

type

PRIMARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice