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NCT01566721 · OUTCOME

Number of Herceptin Cycles Received

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
MEDIAN
Unit
cycles
Interval / dispersion
Full Range
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. The median number of cycles actually received was reported.

Analysis population: Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.

Groups in this outcome

Cohort B: SC Herceptin by SID (Self-Administered)

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. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.

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 B: SC Herceptin by SID (Self-Administered)550
Cohort A: SC Herceptin by Needle/Syringe1864
Cohort B: SC Herceptin by SID709

Reported measurements

Source class 1
Values in cycles · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self-Administered)16.0Not reported117Not reported
Cohort A: SC Herceptin by Needle/Syringe18.0Not reported119Not reported
Cohort B: SC Herceptin by SID18.0Not reported118Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        17
        value
        16.0
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        19
        value
        18.0
      3. group Id
        OG002
        lower Limit
        1
        upper Limit
        18
        value
        18.0
denoms
  1. counts
    1. group Id
      OG000
      value
      550
    2. group Id
      OG001
      value
      1864
    3. group Id
      OG002
      value
      709
    units
    Participants
description
Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.
dispersion Type
Full Range
groups
  1. 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. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
    id
    OG000
    title
    Cohort B: SC Herceptin by SID (Self-Administered)
  2. 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
    OG001
    title
    Cohort A: SC Herceptin by Needle/Syringe
  3. 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
    OG002
    title
    Cohort B: SC Herceptin by SID
param Type
MEDIAN
population Description
Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.
reporting Status
POSTED
time Frame
From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
title
Number of Herceptin Cycles Received
type
PRIMARY
unit Of Measure
cycles

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

Preserved source evidence · Not medical advice