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NCT02717507 · OUTCOME

Average Left Ventricular Mass

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
MEAN
Unit
g/m^2
Interval / dispersion
Standard Error
Time frame
Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation

What was measured

The weight of the left ventricle adjusted for body surface area (in g/m2). The mean is reported by arm at each timepoint with corresponding standard errors.

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

BL
Values in g/m^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)57.48621.2135Not reportedNot reportedNot reported
Arm II (Placebo)57.93221.5767Not reportedNot reportedNot reported
6m
Values in g/m^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)58.28391.3859Not reportedNot reportedNot reported
Arm II (Placebo)57.09241.29Not reportedNot reportedNot reported
12m
Values in g/m^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)60.21161.6786Not reportedNot reportedNot reported
Arm II (Placebo)59.45081.4995Not reportedNot reportedNot reported
18m
Values in g/m^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)57.70531.6667Not reportedNot reportedNot reported
Arm II (Placebo)59.17931.6168Not reportedNot reportedNot reported
24m
Values in g/m^2 · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)58.33151.6478Not reportedNot reportedNot reported
Arm II (Placebo)59.10261.8092Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -1.134
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.999
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.799
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.59
    param Type
    Slope
    param Value
    0.433
    statistical Comment
    The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
    statistical Method
    Generalized Estimating Equation (GEE)
Complete source fields
analyses
  1. ci Lower Limit
    -1.134
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.999
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    0.799
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.59
    param Type
    Slope
    param Value
    0.433
    statistical Comment
    The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.
    statistical Method
    Generalized Estimating Equation (GEE)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.2135
        value
        57.4862
      2. group Id
        OG001
        spread
        1.5767
        value
        57.9322
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.3859
        value
        58.2839
      2. group Id
        OG001
        spread
        1.29
        value
        57.0924
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6786
        value
        60.2116
      2. group Id
        OG001
        spread
        1.4995
        value
        59.4508
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6667
        value
        57.7053
      2. group Id
        OG001
        spread
        1.6168
        value
        59.1793
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6478
        value
        58.3315
      2. group Id
        OG001
        spread
        1.8092
        value
        59.1026
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
The weight of the left ventricle adjusted for body surface area (in g/m2). The mean is reported by arm at each timepoint with corresponding standard errors.
dispersion Type
Standard Error
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
MEAN
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
Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation
title
Average Left Ventricular Mass
type
SECONDARY
unit Of Measure
g/m^2

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Preserved source evidence · Not medical advice