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NCT01566721 · OUTCOME

Percentage of Participants Who Received Concomitant 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 cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant 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

Chemotherapy
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: SC Herceptin by Needle/Syringe58.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID63.9Not reportedNot reportedNot reportedNot reported
Radiotherapy
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: SC Herceptin by Needle/Syringe51.3Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID48.5Not reportedNot reportedNot reportedNot reported
Hormone Therapy
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A: SC Herceptin by Needle/Syringe53.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID50.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        58.2
      2. group Id
        OG001
        value
        63.9
    title
    Chemotherapy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        51.3
      2. group Id
        OG001
        value
        48.5
    title
    Radiotherapy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        53.5
      2. group Id
        OG001
        value
        50.4
    title
    Hormone Therapy
denoms
  1. counts
    1. group Id
      OG000
      value
      1864
    2. group Id
      OG001
      value
      709
    units
    Participants
description
Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant 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 Cancer Therapy
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice