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NCT01401166 · OUTCOME

Percentage of HCPs by Time Required to Perform Each Method of Drug Administration

Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer · Source last updated 2017-03-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of HCPs
Interval / dispersion
Not reported
Time frame
Week 24

What was measured

The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.

Analysis population: HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.

Groups in this outcome

All HCPs: SC and IV Herceptin

Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All HCPs: SC and IV Herceptin235

Analysis denominator · HCPs

GroupSource count
All HCPs: SC and IV Herceptin235

Reported measurements

SC Herceptin, <5 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin44.3Not reportedNot reportedNot reportedNot reported
SC Herceptin, 6 to 10 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin46.4Not reportedNot reportedNot reportedNot reported
SC Herceptin, 11 to 15 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin3.4Not reportedNot reportedNot reportedNot reported
SC Herceptin, 16 to 20 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin0.4Not reportedNot reportedNot reportedNot reported
SC Herceptin, >20 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin0.4Not reportedNot reportedNot reportedNot reported
SC Herceptin, Not Sure
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin0.0Not reportedNot reportedNot reportedNot reported
SC Herceptin, Unknown
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin5.1Not reportedNot reportedNot reportedNot reported
IV Herceptin, <5 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin11.1Not reportedNot reportedNot reportedNot reported
IV Herceptin, 6 to 10 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin9.8Not reportedNot reportedNot reportedNot reported
IV Herceptin, 11 to 15 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin3.8Not reportedNot reportedNot reportedNot reported
IV Herceptin, 16 to 20 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin44.3Not reportedNot reportedNot reportedNot reported
IV Herceptin, >20 minutes
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin22.1Not reportedNot reportedNot reportedNot reported
IV Herceptin, Not Sure
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin5.1Not reportedNot reportedNot reportedNot reported
IV Herceptin, Unknown
Values in percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All HCPs: SC and IV Herceptin3.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44.3
    title
    SC Herceptin, <5 minutes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46.4
    title
    SC Herceptin, 6 to 10 minutes
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3.4
    title
    SC Herceptin, 11 to 15 minutes
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
    title
    SC Herceptin, 16 to 20 minutes
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
    title
    SC Herceptin, >20 minutes
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
    title
    SC Herceptin, Not Sure
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5.1
    title
    SC Herceptin, Unknown
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        11.1
    title
    IV Herceptin, <5 minutes
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        9.8
    title
    IV Herceptin, 6 to 10 minutes
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        3.8
    title
    IV Herceptin, 11 to 15 minutes
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        44.3
    title
    IV Herceptin, 16 to 20 minutes
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        22.1
    title
    IV Herceptin, >20 minutes
denom Units Selected
HCPs
denoms
  1. counts
    1. group Id
      OG000
      value
      235
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      235
    units
    HCPs
description
The time required to perform each method of drug administration was assessed via questionnaire with each HCP by asking to rate the amount of time it took to administer each method of drug administration (IV or SC Herceptin) at the end of the crossover period (Week 24). Time was rated in the following time block categories: less than (\<) 5 minutes, 6 to 10 minutes, 11 to 15 minutes, 16 to 20 minutes, and greater than (\>) 20 minutes. Responses of "Not Sure" and "Unknown" were also allowed. The percentage of HCPs who rated the amount of time in each of the categories was reported.
groups
  1. description
    Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
    id
    OG000
    title
    All HCPs: SC and IV Herceptin
param Type
NUMBER
population Description
HCP Population. Results were planned to be analyzed for all HCPs combined because the objective of the study was to compare HCP perceived time savings with use of SC over IV Herceptin.
reporting Status
POSTED
time Frame
Week 24
title
Percentage of HCPs by Time Required to Perform Each Method of Drug Administration
type
SECONDARY
type Units Analyzed
HCPs
unit Of Measure
percentage of HCPs

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

Preserved source evidence · Not medical advice