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NCT03674112 · OUTCOME

Percentage of Healthcare Professionals (HCPs) by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Drug Preparation Room

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer · Source last updated 2024-01-02

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
Day 1 of Cycle 6 (each cycle is 21 days)

What was measured

Healthcare professionals (HCPs) who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Question 2: "If all P+H IV infusions are switched to FDC SC injections, please indicate how strongly you agree or disagree with each of the following statements: a) Staff will have increased availability for other tasks in the pharmacy; b) Administrative procedures around FDC SC will require less time; c) FDC SC formulations will provide more flexibility for staff in managing their workload; d) Due to ready-to-use FDC SC formulations, potential dosing errors will be avoided; e) Due to ready-to-use FDC SC formulations, there will be less drug wastage; f) Without having to reconstitute the drug, less storage space for FDC SC related supplies will be required in the pharmacy; g) Preparation procedures and associated time staff time commitment will be reduced."

Analysis population: The number analyzed includes healthcare professionals (HCPs) who completed any part of the survey at treatment Cycle 6.

Groups in this outcome

All Healthcare Professionals

This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

A: P+H IV Followed by PH FDC SC

In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

B: PH FDC SC Followed by P+H IV

In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.

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 Healthcare Professionals160
A: P+H IV Followed by PH FDC SC80
B: PH FDC SC Followed by P+H IV80

Reported measurements

Statement a): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement a): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV0.0Not reportedNot reportedNot reportedNot reported
Statement a): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals7.5Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC8.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV6.3Not reportedNot reportedNot reportedNot reported
Statement a): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals28.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC28.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV28.8Not reportedNot reportedNot reportedNot reported
Statement a): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals50.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC52.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV48.8Not reportedNot reportedNot reportedNot reported
Statement a): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals2.5Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC3.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement a): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals8.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC3.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Statement b): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals5.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC8.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV2.5Not reportedNot reportedNot reportedNot reported
Statement b): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals3.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC3.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV3.8Not reportedNot reportedNot reportedNot reported
Statement b): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals14.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC16.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV12.5Not reportedNot reportedNot reportedNot reported
Statement b): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals18.1Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC17.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV18.8Not reportedNot reportedNot reportedNot reported
Statement b): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals46.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC46.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV46.3Not reportedNot reportedNot reportedNot reported
Statement b): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals2.5Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC2.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV2.5Not reportedNot reportedNot reportedNot reported
Statement b): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals9.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Statement c): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement c): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement c): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals13.1Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC15.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV11.3Not reportedNot reportedNot reportedNot reported
Statement c): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals26.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC28.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV23.8Not reportedNot reportedNot reportedNot reported
Statement c): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals48.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC50.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV47.5Not reportedNot reportedNot reportedNot reported
Statement c): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement c): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals9.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Statement d): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement d): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals3.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV6.3Not reportedNot reportedNot reportedNot reported
Statement d): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals5.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV6.3Not reportedNot reportedNot reportedNot reported
Statement d): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals23.1Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC26.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV20.0Not reportedNot reportedNot reportedNot reported
Statement d): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals56.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC60.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV52.5Not reportedNot reportedNot reportedNot reported
Statement d): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement d): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals8.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV12.5Not reportedNot reportedNot reportedNot reported
Statement e): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement e): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV2.5Not reportedNot reportedNot reportedNot reported
Statement e): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals8.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC11.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV6.3Not reportedNot reportedNot reportedNot reported
Statement e): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals21.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC21.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV22.5Not reportedNot reportedNot reportedNot reported
Statement e): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals55.0Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC58.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV51.3Not reportedNot reportedNot reportedNot reported
Statement e): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV2.5Not reportedNot reportedNot reportedNot reported
Statement e): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals9.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Statement f): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement f): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals4.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC3.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV5.0Not reportedNot reportedNot reportedNot reported
Statement f): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals11.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC16.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV7.5Not reportedNot reportedNot reportedNot reported
Statement f): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals24.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC20.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV28.8Not reportedNot reportedNot reportedNot reported
Statement f): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals48.1Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC53.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV42.5Not reportedNot reportedNot reportedNot reported
Statement f): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals1.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC1.3Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement f): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals9.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Statement g): Strongly Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.6Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV1.3Not reportedNot reportedNot reportedNot reported
Statement g): Disagree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals0.0Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC0.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV0.0Not reportedNot reportedNot reportedNot reported
Statement g): Neutral
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals6.9Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC8.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV5.0Not reportedNot reportedNot reportedNot reported
Statement g): Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals31.3Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC30.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV32.5Not reportedNot reportedNot reportedNot reported
Statement g): Strongly Agree
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals48.8Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC52.5Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV45.0Not reportedNot reportedNot reportedNot reported
Statement g): Not Applicable
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals3.1Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC3.8Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV2.5Not reportedNot reportedNot reportedNot reported
Statement g): Answer Missing
Values in Percentage of HCPs · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Healthcare Professionals9.4Not reportedNot reportedNot reportedNot reported
A: P+H IV Followed by PH FDC SC5.0Not reportedNot reportedNot reportedNot reported
B: PH FDC SC Followed by P+H IV13.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.3
      2. group Id
        OG001
        value
        1.3
      3. group Id
        OG002
        value
        1.3
    title
    Statement a): Strongly Disagree
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0.6
      2. group Id
        OG001
        value
        1.3
      3. group Id
        OG002
        value
        0.0
    title
    Statement a): Disagree
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7.5
      2. group Id
        OG001
        value
        8.8
      3. group Id
        OG002
        value
        6.3
    title
    Statement a): Neutral
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        28.8
      2. group Id
        OG001
        value
        28.8
      3. group Id
        OG002
        value
        28.8
    title
    Statement a): Agree
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        50.6
      2. group Id
        OG001
        value
        52.5
      3. group Id
        OG002
        value
        48.8
    title
    Statement a): Strongly Agree
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2.5
      2. group Id
        OG001
        value
        3.8
      3. group Id
        OG002
        value
        1.3
    title
    Statement a): Not Applicable
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8.8
      2. group Id
        OG001
        value
        3.8
      3. group Id
        OG002
        value
        13.8
    title
    Statement a): Answer Missing
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5.6
      2. group Id
        OG001
        value
        8.8
      3. group Id
        OG002
        value
        2.5
    title
    Statement b): Strongly Disagree
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3.8
      2. group Id
        OG001
        value
        3.8
      3. group Id
        OG002
        value
        3.8
    title
    Statement b): Disagree
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        14.4
      2. group Id
        OG001
        value
        16.3
      3. group Id
        OG002
        value
        12.5
    title
    Statement b): Neutral
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        18.1
      2. group Id
        OG001
        value
        17.5
      3. group Id
        OG002
        value
        18.8
    title
    Statement b): Agree
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        46.3
      2. group Id
        OG001
        value
        46.3
      3. group Id
        OG002
        value
        46.3
    title
    Statement b): Strongly Agree
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      80
    3. group Id
      OG002
      value
      80
    units
    Participants
description
Healthcare professionals (HCPs) who prepared study treatment within the pharmacy/drug preparation area responded at Cycle 6 of the Treatment Cross-Over Period to the following HCPQ-Drug Preparation Room Question 2: "If all P+H IV infusions are switched to FDC SC injections, please indicate how strongly you agree or disagree with each of the following statements: a) Staff will have increased availability for other tasks in the pharmacy; b) Administrative procedures around FDC SC will require less time; c) FDC SC formulations will provide more flexibility for staff in managing their workload; d) Due to ready-to-use FDC SC formulations, potential dosing errors will be avoided; e) Due to ready-to-use FDC SC formulations, there will be less drug wastage; f) Without having to reconstitute the drug, less storage space for FDC SC related supplies will be required in the pharmacy; g) Preparation procedures and associated time staff time commitment will be reduced."
groups
  1. description
    This analysis set includes all healthcare professionals who treated participants from Arms A and B and completed the HCPQ questionnaire, which was administered at the last treatment cycle in the Treatment Cross-Over Period of the study. During the Treatment Cross-Over Period of the study, all participants received their first 6 cycles of treatment in accordance with the study arm to which they were randomized: Arm A) pertuzumab IV and trastuzumab IV (P+H IV) for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days); or Arm B) PH FDC SC for 3 treatment cycles followed by P+H IV for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG000
    title
    All Healthcare Professionals
  2. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm A first received pertuzumab IV and trastuzumab IV (P+H IV) administration for 3 treatment cycles followed by the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG001
    title
    A: P+H IV Followed by PH FDC SC
  3. description
    In the Treatment Cross-Over Period of the study, participants randomized to Arm B first received the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) for 3 treatment cycles followed by pertuzumab intravenous (IV) and trastuzumab IV (P+H IV) administration for 3 treatment cycles (1 cycle = 21 days). Following completion of this study period, participants chose one of the two study treatments to receive in the Treatment Continuation Period for the remaining anti-HER2 treatment cycles (18 planned cycles in total, including pre-study neoadjuvant treatment). After completing study treatment, participants entered the Follow-up Period wherein they were to be followed for 3 years from the date the last participant was randomized.
    id
    OG002
    title
    B: PH FDC SC Followed by P+H IV
param Type
NUMBER
population Description
The number analyzed includes healthcare professionals (HCPs) who completed any part of the survey at treatment Cycle 6.
reporting Status
POSTED
time Frame
Day 1 of Cycle 6 (each cycle is 21 days)
title
Percentage of Healthcare Professionals (HCPs) by Their Responses on Perception of Impact of PH FDC SC on Clinical Management and Clinical Efficiency, Question 2 of the HCPQ - Drug Preparation Room
type
SECONDARY
unit Of Measure
Percentage of HCPs

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