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NCT02717507 · OUTCOME

Proportion of Patients Who Responded "Moderately", "Quite a Bit", or "Extremely" to the Question of How Bothersome the Listed Symptom Was at Any Post-day 0 Assessment Time Point.

Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors · Source last updated 2025-04-23

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

Measure
NUMBER
Unit
Proportion of patients
Interval / dispersion
95% Confidence Interval
Time frame
Responses at days 14 to 730 were combined

What was measured

In a questionnaire, patients responded Yes/No to certain symptoms. If answered Yes, they selected "slightly", "moderately", "quite a bit", or "extremely" regarding how bothersome the symptom was. The proportion of participants responding with any of these three categories was calculated by arm, and corresponding 95% confidence intervals are reported.

Analysis population: We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.

Groups in this outcome

Arm I (Carvedilol)

Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.

Arm II (Placebo)

Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.

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

Analysis denominator · Participants

GroupSource count
Arm I (Carvedilol)75
Arm II (Placebo)76

Reported measurements

Diarrhea
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0533Not reported0.00250.1042Not reported
Arm II (Placebo)0.1316Not reported0.05560.2076Not reported
Skin rash
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0933Not reported0.00250.1042Not reported
Arm II (Placebo)0.0789Not reported0.01830.1396Not reported
Itchy skin
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.1467Not reported0.06660.2267Not reported
Arm II (Placebo)0.1447Not reported0.06560.2238Not reported
Dry Mouth
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0667Not reported0.01020.1231Not reported
Arm II (Placebo)0.1711Not reported0.08640.2557Not reported
Easy bruising
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0133Not reported00.0393Not reported
Arm II (Placebo)0.0921Not reported0.02710.1571Not reported
Nosebleeds
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0667Not reported0.01020.1231Not reported
Arm II (Placebo)0.0526Not reported0.00240.1028Not reported
Sunburn easily
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0933Not reported0.02750.1592Not reported
Arm II (Placebo)0.0526Not reported0.00240.1028Not reported
Weight gain
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0533Not reported0.00250.1042Not reported
Arm II (Placebo)0.0789Not reported0.01830.1396Not reported
Fluid retention
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0267Not reported00.0631Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Swollen feet
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0Not reported00.048Not reported
Arm II (Placebo)0.0921Not reported0.02710.1571Not reported
Increased sweating
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0933Not reported0.02750.1592Not reported
Arm II (Placebo)0.0789Not reported0.01830.1396Not reported
Feeling weak in parts of your body
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0933Not reported0.02750.1592Not reported
Arm II (Placebo)0.1316Not reported0.05560.2076Not reported
Shortness of breath or wheezing
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0933Not reported0.02750.1592Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Chest pain or heaviness
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.08Not reported0.01860.1414Not reported
Arm II (Placebo)0.0921Not reported0.02710.1571Not reported
Heart racing or skipping beats
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.08Not reported0.01860.1414Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Feeling shaky or having tremors
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0533Not reported0.00250.1042Not reported
Arm II (Placebo)0.0789Not reported0.01830.1396Not reported
Decreased bodily movement
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0133Not reported00.0393Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Feeling nervous
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.1467Not reported0.06660.2267Not reported
Arm II (Placebo)0.1711Not reported0.08640.2557Not reported
Feeling downhearted, sad, and/or tearful
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.2Not reported0.10950.2905Not reported
Arm II (Placebo)0.1184Not reported0.04580.1911Not reported
Mood swings
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.12Not reported0.04650.1935Not reported
Arm II (Placebo)0.0921Not reported0.02710.1571Not reported
Dizziness and/or lightheadedness
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.16Not reported0.0770.243Not reported
Arm II (Placebo)0.1316Not reported0.05560.2076Not reported
Dizziness upon standing (from sitting or lying down)
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.1467Not reported0.06660.2267Not reported
Arm II (Placebo)0.1579Not reported0.07590.2399Not reported
Insomnia
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.1733Not reported0.08770.259Not reported
Arm II (Placebo)0.1711Not reported0.08640.2557Not reported
Difficulty concentrating
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.1067Not reported0.03680.1765Not reported
Arm II (Placebo)0.1316Not reported0.05560.2076Not reported
Interrupted sleep
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.2Not reported0.10950.2905Not reported
Arm II (Placebo)0.2105Not reported0.11890.3022Not reported
Tendency to take naps
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.12Not reported0.04650.1935Not reported
Arm II (Placebo)0.1053Not reported0.03630.1743Not reported
Feeling unusually tired
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.2267Not reported0.13190.3214Not reported
Arm II (Placebo)0.2237Not reported0.130.3174Not reported
Falling asleep at inappropriate times
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0267Not reported00.0631Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Ringing in the ears
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0533Not reported0.00250.1042Not reported
Arm II (Placebo)0.0921Not reported0.02710.1571Not reported
Difficulty breathing
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0267Not reported00.0631Not reported
Arm II (Placebo)0Not reported00.0474Not reported
Sensation that I have to urinate much of the time
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0667Not reported0.01020.1231Not reported
Arm II (Placebo)0.0789Not reported0.01830.1396Not reported
Discoloration of urine (i.e., bloody)
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0Not reported00.048Not reported
Arm II (Placebo)0.0395Not reported00.0833Not reported
Decreased libido
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0667Not reported0.01020.1231Not reported
Arm II (Placebo)0.0526Not reported0.00240.1028Not reported
Unusually heavy menstrual flows (N/A if postmenopausal or male)
Values in Proportion of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.2Not reported0.04320.3568Not reported
Arm II (Placebo)0.111Not reported00.230Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0025
        upper Limit
        0.1042
        value
        0.0533
      2. group Id
        OG001
        lower Limit
        0.0556
        upper Limit
        0.2076
        value
        0.1316
    title
    Diarrhea
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0025
        upper Limit
        0.1042
        value
        0.0933
      2. group Id
        OG001
        lower Limit
        0.0183
        upper Limit
        0.1396
        value
        0.0789
    title
    Skin rash
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0666
        upper Limit
        0.2267
        value
        0.1467
      2. group Id
        OG001
        lower Limit
        0.0656
        upper Limit
        0.2238
        value
        0.1447
    title
    Itchy skin
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0102
        upper Limit
        0.1231
        value
        0.0667
      2. group Id
        OG001
        lower Limit
        0.0864
        upper Limit
        0.2557
        value
        0.1711
    title
    Dry Mouth
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.0393
        value
        0.0133
      2. group Id
        OG001
        lower Limit
        0.0271
        upper Limit
        0.1571
        value
        0.0921
    title
    Easy bruising
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0102
        upper Limit
        0.1231
        value
        0.0667
      2. group Id
        OG001
        lower Limit
        0.0024
        upper Limit
        0.1028
        value
        0.0526
    title
    Nosebleeds
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0275
        upper Limit
        0.1592
        value
        0.0933
      2. group Id
        OG001
        lower Limit
        0.0024
        upper Limit
        0.1028
        value
        0.0526
    title
    Sunburn easily
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0025
        upper Limit
        0.1042
        value
        0.0533
      2. group Id
        OG001
        lower Limit
        0.0183
        upper Limit
        0.1396
        value
        0.0789
    title
    Weight gain
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.0631
        value
        0.0267
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0.0833
        value
        0.0395
    title
    Fluid retention
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0.048
        value
        0
      2. group Id
        OG001
        lower Limit
        0.0271
        upper Limit
        0.1571
        value
        0.0921
    title
    Swollen feet
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0275
        upper Limit
        0.1592
        value
        0.0933
      2. group Id
        OG001
        lower Limit
        0.0183
        upper Limit
        0.1396
        value
        0.0789
    title
    Increased sweating
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0275
        upper Limit
        0.1592
        value
        0.0933
      2. group Id
        OG001
        lower Limit
        0.0556
        upper Limit
        0.2076
        value
        0.1316
    title
    Feeling weak in parts of your body
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
In a questionnaire, patients responded Yes/No to certain symptoms. If answered Yes, they selected "slightly", "moderately", "quite a bit", or "extremely" regarding how bothersome the symptom was. The proportion of participants responding with any of these three categories was calculated by arm, and corresponding 95% confidence intervals are reported.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
    id
    OG000
    title
    Arm I (Carvedilol)
  2. description
    Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.
    id
    OG001
    title
    Arm II (Placebo)
param Type
NUMBER
population Description
We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.
reporting Status
POSTED
time Frame
Responses at days 14 to 730 were combined
title
Proportion of Patients Who Responded "Moderately", "Quite a Bit", or "Extremely" to the Question of How Bothersome the Listed Symptom Was at Any Post-day 0 Assessment Time Point.
type
SECONDARY
unit Of Measure
Proportion of patients

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