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NCT02717507 · OUTCOME

Average Alanine Aminotransferase

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
IU/L
Interval / dispersion
Standard Error
Time frame
Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation

What was measured

A liver function measurement (in U/L). Normal range is 8-48 IU/L. 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 IU/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)29.1222.31Not reportedNot reportedNot reported
Arm II (Placebo)30.4671.948Not reportedNot reportedNot reported
6m
Values in IU/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)28.0142.533Not reportedNot reportedNot reported
Arm II (Placebo)32.1582.516Not reportedNot reportedNot reported
12m
Values in IU/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)30.1482.985Not reportedNot reportedNot reported
Arm II (Placebo)31.1552.742Not reportedNot reportedNot reported
18m
Values in IU/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)27.1962.645Not reportedNot reportedNot reported
Arm II (Placebo)30.5363.567Not reportedNot reportedNot reported
24m
Values in IU/L · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)29.863.064Not reportedNot reportedNot reported
Arm II (Placebo)29.2452.626Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -5.595
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.091
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.491
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.
    group Description
    The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.72
    param Type
    Slope
    param Value
    1.248
    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
    -5.595
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.091
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.491
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.
    group Description
    The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.72
    param Type
    Slope
    param Value
    1.248
    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
        2.31
        value
        29.122
      2. group Id
        OG001
        spread
        1.948
        value
        30.467
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.533
        value
        28.014
      2. group Id
        OG001
        spread
        2.516
        value
        32.158
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.985
        value
        30.148
      2. group Id
        OG001
        spread
        2.742
        value
        31.155
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.645
        value
        27.196
      2. group Id
        OG001
        spread
        3.567
        value
        30.536
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.064
        value
        29.86
      2. group Id
        OG001
        spread
        2.626
        value
        29.245
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
A liver function measurement (in U/L). Normal range is 8-48 IU/L. 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 Alanine Aminotransferase
type
SECONDARY
unit Of Measure
IU/L

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Preserved source evidence · Not medical advice