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NCT01772472 · OUTCOME

Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)

A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE) · Source last updated 2025-07-22

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

Measure
MEAN
Unit
score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)

What was measured

EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL.

Analysis population: ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.

Groups in this outcome

Trastuzumab

Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

Trastuzumab Emtansine

Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.

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

Analysis denominator · Participants

GroupSource count
Trastuzumab743
Trastuzumab Emtansine743

Reported measurements

Baseline: Body Image

Analysis denominator · Participants

GroupSource count
Trastuzumab622
Trastuzumab Emtansine645
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab69.828.5Not reportedNot reportedNot reported
Trastuzumab Emtansine67.528.5Not reportedNot reportedNot reported
Change at Cycle 5: Body Image

Analysis denominator · Participants

GroupSource count
Trastuzumab555
Trastuzumab Emtansine571
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab1.520.5Not reportedNot reportedNot reported
Trastuzumab Emtansine4.622.7Not reportedNot reportedNot reported
Change at Cycle 11: Body Image

Analysis denominator · Participants

GroupSource count
Trastuzumab493
Trastuzumab Emtansine495
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab3.424.4Not reportedNot reportedNot reported
Trastuzumab Emtansine5.723.9Not reportedNot reportedNot reported
Change at FU Month 6: Body Image

Analysis denominator · Participants

GroupSource count
Trastuzumab409
Trastuzumab Emtansine462
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab3.625.1Not reportedNot reportedNot reported
Trastuzumab Emtansine7.825.8Not reportedNot reportedNot reported
Change at FU Month 12: Body Image

Analysis denominator · Participants

GroupSource count
Trastuzumab383
Trastuzumab Emtansine428
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab6.227.1Not reportedNot reportedNot reported
Trastuzumab Emtansine6.127.2Not reportedNot reportedNot reported
Baseline: FP

Analysis denominator · Participants

GroupSource count
Trastuzumab622
Trastuzumab Emtansine645
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab51.331.2Not reportedNot reportedNot reported
Trastuzumab Emtansine50.131.7Not reportedNot reportedNot reported
Change at Cycle 5: FP

Analysis denominator · Participants

GroupSource count
Trastuzumab555
Trastuzumab Emtansine571
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab2.628.3Not reportedNot reportedNot reported
Trastuzumab Emtansine6.529.9Not reportedNot reportedNot reported
Change at Cycle 11: FP

Analysis denominator · Participants

GroupSource count
Trastuzumab493
Trastuzumab Emtansine495
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab6.330.0Not reportedNot reportedNot reported
Trastuzumab Emtansine6.131.4Not reportedNot reportedNot reported
Change at FU Month 6: FP

Analysis denominator · Participants

GroupSource count
Trastuzumab409
Trastuzumab Emtansine462
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab7.733.5Not reportedNot reportedNot reported
Trastuzumab Emtansine8.134.6Not reportedNot reportedNot reported
Change at FU Month 12: FP

Analysis denominator · Participants

GroupSource count
Trastuzumab383
Trastuzumab Emtansine428
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab8.131.1Not reportedNot reportedNot reported
Trastuzumab Emtansine8.233.0Not reportedNot reportedNot reported
Baseline: Sexual Enjoyment

Analysis denominator · Participants

GroupSource count
Trastuzumab218
Trastuzumab Emtansine241
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab50.928.8Not reportedNot reportedNot reported
Trastuzumab Emtansine52.328.5Not reportedNot reportedNot reported
Change at Cycle 5: Sexual Enjoyment

Analysis denominator · Participants

GroupSource count
Trastuzumab147
Trastuzumab Emtansine172
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab2.326.4Not reportedNot reportedNot reported
Trastuzumab Emtansine-1.924.6Not reportedNot reportedNot reported
Change at Cycle 11: Sexual Enjoyment

Analysis denominator · Participants

GroupSource count
Trastuzumab128
Trastuzumab Emtansine137
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab4.427.5Not reportedNot reportedNot reported
Trastuzumab Emtansine4.424.5Not reportedNot reportedNot reported
Change at FU Month 6: Sexual Enjoyment

Analysis denominator · Participants

GroupSource count
Trastuzumab104
Trastuzumab Emtansine126
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab3.228.1Not reportedNot reportedNot reported
Trastuzumab Emtansine0.327.5Not reportedNot reportedNot reported
Change at FU Month 12: Sexual Enjoyment

Analysis denominator · Participants

GroupSource count
Trastuzumab95
Trastuzumab Emtansine114
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab5.626.0Not reportedNot reportedNot reported
Trastuzumab Emtansine1.826.2Not reportedNot reportedNot reported
Baseline: Sexual Function

Analysis denominator · Participants

GroupSource count
Trastuzumab550
Trastuzumab Emtansine564
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab20.223.6Not reportedNot reportedNot reported
Trastuzumab Emtansine22.023.4Not reportedNot reportedNot reported
Change at Cycle 5: Sexual Function

Analysis denominator · Participants

GroupSource count
Trastuzumab456
Trastuzumab Emtansine466
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab3.320.0Not reportedNot reportedNot reported
Trastuzumab Emtansine2.320.0Not reportedNot reportedNot reported
Change at Cycle 11: Sexual Function

Analysis denominator · Participants

GroupSource count
Trastuzumab393
Trastuzumab Emtansine382
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab3.120.8Not reportedNot reportedNot reported
Trastuzumab Emtansine1.920.3Not reportedNot reportedNot reported
Change at FU Month 6: Sexual Function

Analysis denominator · Participants

GroupSource count
Trastuzumab321
Trastuzumab Emtansine360
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab5.123.9Not reportedNot reportedNot reported
Trastuzumab Emtansine4.323.1Not reportedNot reportedNot reported
Change at FU Month 12: Sexual Function

Analysis denominator · Participants

GroupSource count
Trastuzumab289
Trastuzumab Emtansine319
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab5.923.7Not reportedNot reportedNot reported
Trastuzumab Emtansine5.222.7Not reportedNot reportedNot reported
Baseline: Arm Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab622
Trastuzumab Emtansine645
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab24.621.1Not reportedNot reportedNot reported
Trastuzumab Emtansine24.521.0Not reportedNot reportedNot reported
Change at Cycle 5: Arm Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab555
Trastuzumab Emtansine571
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-2.820.9Not reportedNot reportedNot reported
Trastuzumab Emtansine-2.623.0Not reportedNot reportedNot reported
Change at Cycle 11: Arm Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab493
Trastuzumab Emtansine495
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-2.621.2Not reportedNot reportedNot reported
Trastuzumab Emtansine0.224.2Not reportedNot reportedNot reported
Change at FU Month 6: Arm Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab409
Trastuzumab Emtansine462
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-3.023.5Not reportedNot reportedNot reported
Trastuzumab Emtansine-1.324.2Not reportedNot reportedNot reported
Change at FU Month 12: Arm Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab383
Trastuzumab Emtansine428
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-5.722.8Not reportedNot reportedNot reported
Trastuzumab Emtansine-1.522.6Not reportedNot reportedNot reported
Baseline: Breast Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab622
Trastuzumab Emtansine645
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab22.719.1Not reportedNot reportedNot reported
Trastuzumab Emtansine21.417.9Not reportedNot reportedNot reported
Change at Cycle 5: Breast Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab555
Trastuzumab Emtansine571
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-1.120.3Not reportedNot reportedNot reported
Trastuzumab Emtansine-1.119.1Not reportedNot reportedNot reported
Change at Cycle 11: Breast Symptoms

Analysis denominator · Participants

GroupSource count
Trastuzumab493
Trastuzumab Emtansine495
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-3.719.8Not reportedNot reportedNot reported
Trastuzumab Emtansine-0.619.5Not reportedNot reportedNot reported
Change at FU Month 6: Breast Function

Analysis denominator · Participants

GroupSource count
Trastuzumab409
Trastuzumab Emtansine462
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-6.520.0Not reportedNot reportedNot reported
Trastuzumab Emtansine-2.219.7Not reportedNot reportedNot reported
Change at Follow-up Month 12: Breast Function

Analysis denominator · Participants

GroupSource count
Trastuzumab383
Trastuzumab Emtansine428
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-8.319.9Not reportedNot reportedNot reported
Trastuzumab Emtansine-3.819.2Not reportedNot reportedNot reported
Baseline: Systemic Therapy Side Effects (SE)

Analysis denominator · Participants

GroupSource count
Trastuzumab622
Trastuzumab Emtansine645
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab16.713.7Not reportedNot reportedNot reported
Trastuzumab Emtansine16.914.1Not reportedNot reportedNot reported
Change at Cycle 5: Systemic Therapy SE

Analysis denominator · Participants

GroupSource count
Trastuzumab555
Trastuzumab Emtansine571
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab0.713.0Not reportedNot reportedNot reported
Trastuzumab Emtansine5.515.3Not reportedNot reportedNot reported
Change at Cycle 11: Systemic Therapy SE

Analysis denominator · Participants

GroupSource count
Trastuzumab493
Trastuzumab Emtansine495
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab1.212.2Not reportedNot reportedNot reported
Trastuzumab Emtansine4.215.4Not reportedNot reportedNot reported
Change at FU Month 6: Systemic Therapy SE

Analysis denominator · Participants

GroupSource count
Trastuzumab409
Trastuzumab Emtansine462
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab1.913.9Not reportedNot reportedNot reported
Trastuzumab Emtansine1.115.3Not reportedNot reportedNot reported
Change at FU Month 12: Systemic Therapy SE

Analysis denominator · Participants

GroupSource count
Trastuzumab383
Trastuzumab Emtansine428
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab1.313.9Not reportedNot reportedNot reported
Trastuzumab Emtansine1.416.3Not reportedNot reportedNot reported
Baseline: Upset by Hair Loss Item

Analysis denominator · Participants

GroupSource count
Trastuzumab77
Trastuzumab Emtansine96
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab40.335.6Not reportedNot reportedNot reported
Trastuzumab Emtansine50.738.4Not reportedNot reportedNot reported
Change at Cycle 5: Upset by Hair Loss Item

Analysis denominator · Participants

GroupSource count
Trastuzumab13
Trastuzumab Emtansine17
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-5.138.1Not reportedNot reportedNot reported
Trastuzumab Emtansine-17.639.3Not reportedNot reportedNot reported
Change at Cycle 11: Upset by Hair Loss Item

Analysis denominator · Participants

GroupSource count
Trastuzumab14
Trastuzumab Emtansine14
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-28.645.0Not reportedNot reportedNot reported
Trastuzumab Emtansine-14.333.9Not reportedNot reportedNot reported
Change at FU Month 6: Upset by Hair Loss Item

Analysis denominator · Participants

GroupSource count
Trastuzumab25
Trastuzumab Emtansine22
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-12.047.0Not reportedNot reportedNot reported
Trastuzumab Emtansine-15.242.1Not reportedNot reportedNot reported
Change at FU Month 12: Upset by Hair Loss Item

Analysis denominator · Participants

GroupSource count
Trastuzumab23
Trastuzumab Emtansine21
Values in score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Trastuzumab-2.937.5Not reportedNot reportedNot reported
Trastuzumab Emtansine-14.341.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.5
        value
        69.8
      2. group Id
        OG001
        spread
        28.5
        value
        67.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        622
      2. group Id
        OG001
        value
        645
      units
      Participants
    title
    Baseline: Body Image
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.5
        value
        1.5
      2. group Id
        OG001
        spread
        22.7
        value
        4.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        555
      2. group Id
        OG001
        value
        571
      units
      Participants
    title
    Change at Cycle 5: Body Image
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.4
        value
        3.4
      2. group Id
        OG001
        spread
        23.9
        value
        5.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        493
      2. group Id
        OG001
        value
        495
      units
      Participants
    title
    Change at Cycle 11: Body Image
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.1
        value
        3.6
      2. group Id
        OG001
        spread
        25.8
        value
        7.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        409
      2. group Id
        OG001
        value
        462
      units
      Participants
    title
    Change at FU Month 6: Body Image
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.1
        value
        6.2
      2. group Id
        OG001
        spread
        27.2
        value
        6.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        383
      2. group Id
        OG001
        value
        428
      units
      Participants
    title
    Change at FU Month 12: Body Image
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.2
        value
        51.3
      2. group Id
        OG001
        spread
        31.7
        value
        50.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        622
      2. group Id
        OG001
        value
        645
      units
      Participants
    title
    Baseline: FP
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.3
        value
        2.6
      2. group Id
        OG001
        spread
        29.9
        value
        6.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        555
      2. group Id
        OG001
        value
        571
      units
      Participants
    title
    Change at Cycle 5: FP
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.0
        value
        6.3
      2. group Id
        OG001
        spread
        31.4
        value
        6.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        493
      2. group Id
        OG001
        value
        495
      units
      Participants
    title
    Change at Cycle 11: FP
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        33.5
        value
        7.7
      2. group Id
        OG001
        spread
        34.6
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        409
      2. group Id
        OG001
        value
        462
      units
      Participants
    title
    Change at FU Month 6: FP
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.1
        value
        8.1
      2. group Id
        OG001
        spread
        33.0
        value
        8.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        383
      2. group Id
        OG001
        value
        428
      units
      Participants
    title
    Change at FU Month 12: FP
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        28.8
        value
        50.9
      2. group Id
        OG001
        spread
        28.5
        value
        52.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        218
      2. group Id
        OG001
        value
        241
      units
      Participants
    title
    Baseline: Sexual Enjoyment
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        26.4
        value
        2.3
      2. group Id
        OG001
        spread
        24.6
        value
        -1.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        147
      2. group Id
        OG001
        value
        172
      units
      Participants
    title
    Change at Cycle 5: Sexual Enjoyment
denoms
  1. counts
    1. group Id
      OG000
      value
      743
    2. group Id
      OG001
      value
      743
    units
    Participants
description
EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Obtained scores are linearly transformed to a score range of 0-100. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated deterioration in QOL and negative change from baseline indicated an improvement in QOL. For symptom scales, positive change from baseline indicated an improvement in QOL and negative change from baseline indicated a deterioration in QOL.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received trastuzumab, 6 mg/kg, IV, Q3W, as a maintenance dose for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG000
    title
    Trastuzumab
  2. description
    Participants received trastuzumab emtansine, 3.6 mg/kg, IV, Q3W for 14 cycles (1 cycle = 21 days) or until disease recurrence or unacceptable toxicity which ever occurs first.
    id
    OG001
    title
    Trastuzumab Emtansine
param Type
MEAN
population Description
ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed per timepoint are unique number of participants out of all the assessed participants with data available for analysis at the specified timepoint. Different participants may have contributed data for each timepoint.
reporting Status
POSTED
time Frame
Baseline, Cycles 5 &11, Follow-up (FU) Month 6, FU Month 12 (1 cycle = 21 days)
title
Change From Baseline in EORTC Quality of Life Questionnaire - Breast Cancer (QLQ-BR23)
type
SECONDARY
unit Of Measure
score on a scale

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

Preserved source evidence · Not medical advice