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NCT01566721 · OUTCOME

Percentage of Participants by Total 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
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. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.

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

1 Cycle Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)2.7Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe1.0Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.8Not reportedNot reportedNot reportedNot reported
2 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.3Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.4Not reportedNot reportedNot reportedNot reported
3 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.1Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.1Not reportedNot reportedNot reportedNot reported
4 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.6Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe1.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.7Not reportedNot reportedNot reportedNot reported
5 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.3Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.8Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.6Not reportedNot reportedNot reportedNot reported
6 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.6Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.1Not reportedNot reportedNot reportedNot reported
7 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)2.2Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.7Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.8Not reportedNot reportedNot reportedNot reported
8 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)2.2Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.9Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.3Not reportedNot reportedNot reportedNot reported
9 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.8Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.6Not reportedNot reportedNot reportedNot reported
10 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)1.5Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.3Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.1Not reportedNot reportedNot reportedNot reported
11 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)3.5Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.4Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.3Not reportedNot reportedNot reportedNot reported
12 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)2.5Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.9Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.8Not reportedNot reportedNot reportedNot reported
13 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)4.9Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0Not reportedNot reportedNot reportedNot reported
14 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)6.9Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.6Not reportedNot reportedNot reportedNot reported
15 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)10.7Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.5Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.4Not reportedNot reportedNot reportedNot reported
16 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)21.6Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.6Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0.3Not reportedNot reportedNot reportedNot reported
17 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)32.5Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe1.0Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID1.1Not reportedNot reportedNot reportedNot reported
18 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)0Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe89.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID91.8Not reportedNot reportedNot reportedNot reported
19 Cycles Received
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort B: SC Herceptin by SID (Self- Administered)0Not reportedNot reportedNot reportedNot reported
Cohort A: SC Herceptin by Needle/Syringe0.2Not reportedNot reportedNot reportedNot reported
Cohort B: SC Herceptin by SID0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.7
      2. group Id
        OG001
        value
        1.0
      3. group Id
        OG002
        value
        0.8
    title
    1 Cycle Received
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
      2. group Id
        OG001
        value
        0.5
      3. group Id
        OG002
        value
        0.4
    title
    2 Cycles Received
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1.1
      2. group Id
        OG001
        value
        0.5
      3. group Id
        OG002
        value
        0.1
    title
    3 Cycles Received
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
      2. group Id
        OG001
        value
        1.2
      3. group Id
        OG002
        value
        0.7
    title
    4 Cycles Received
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
      2. group Id
        OG001
        value
        0.8
      3. group Id
        OG002
        value
        0.6
    title
    5 Cycles Received
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1.6
      2. group Id
        OG001
        value
        0.5
      3. group Id
        OG002
        value
        0.1
    title
    6 Cycles Received
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2.2
      2. group Id
        OG001
        value
        0.7
      3. group Id
        OG002
        value
        0.8
    title
    7 Cycles Received
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2.2
      2. group Id
        OG001
        value
        0.9
      3. group Id
        OG002
        value
        0.3
    title
    8 Cycles Received
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1.8
      2. group Id
        OG001
        value
        0.2
      3. group Id
        OG002
        value
        0.6
    title
    9 Cycles Received
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1.5
      2. group Id
        OG001
        value
        0.3
      3. group Id
        OG002
        value
        0.1
    title
    10 Cycles Received
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        3.5
      2. group Id
        OG001
        value
        0.4
      3. group Id
        OG002
        value
        0.3
    title
    11 Cycles Received
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2.5
      2. group Id
        OG001
        value
        0.9
      3. group Id
        OG002
        value
        0.8
    title
    12 Cycles Received
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 percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.
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
NUMBER
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
Percentage of Participants by Total Number of Herceptin Cycles Received
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice