NCT01566721 · OUTCOME

Percentage of Participants Who Died by Data Cutoff of 10 March 2015

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 Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)

What was measured

The percentage of participants who died from any cause was reported.

Analysis population: ITT Population

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	1867
Cohort B: SC Herceptin by SID	710

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	1.5	Not reported	Not reported	Not reported	Not reported
Cohort B: SC Herceptin by SID	0.8	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.5
group Id
OG001
value
0.8

denoms

counts
group Id
OG000
value
1867
group Id
OG001
value
710
units
Participants

description

The percentage of participants who died from any cause was reported.

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

ITT Population

reporting Status

POSTED

time Frame

From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)

title

Percentage of Participants Who Died by Data Cutoff of 10 March 2015

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice