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NCT01566721 · OUTCOME

Percentage of Participants Who Received Concomitant Non-Cancer Therapy

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 data cutoff of 10 March 2015 (up to approximately 3 years)

What was measured

Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.

Analysis population: Safety 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

GroupSource count
Cohort A: SC Herceptin by Needle/Syringe1864
Cohort B: SC Herceptin by SID709

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: SC Herceptin by Needle/Syringe89.1Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID89.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89.1
      2. group Id
        OG001
        value
        89.7
denoms
  1. counts
    1. group Id
      OG000
      value
      1864
    2. group Id
      OG001
      value
      709
    units
    Participants
description
Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.
groups
  1. 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
  2. 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
reporting Status
POSTED
time Frame
From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)
title
Percentage of Participants Who Received Concomitant Non-Cancer Therapy
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice