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NCT02717507 · OUTCOME

Average N-terminal Pro B-type Natriuretic Peptide

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

What was measured

B-type natriuretic peptide- a biomarker for heart failure (in pg/ml). 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 pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)27.38362.0697Not reportedNot reportedNot reported
Arm II (Placebo)31.43243.424Not reportedNot reportedNot reported
6m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)31.84063.3339Not reportedNot reportedNot reported
Arm II (Placebo)34.18573.4737Not reportedNot reportedNot reported
12m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)26.82033.4625Not reportedNot reportedNot reported
Arm II (Placebo)33.29414.095Not reportedNot reportedNot reported
18m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)35.8073.7939Not reportedNot reportedNot reported
Arm II (Placebo)32.28074.0405Not reportedNot reportedNot reported
24m
Values in pg/mL · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)34.6253.0875Not reportedNot reportedNot reported
Arm II (Placebo)33.37743.6481Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    -1.387
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.63
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.79
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.24
    param Type
    Slope
    param Value
    2.121
    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
    -1.387
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.63
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.79
    estimate Comment
    The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.24
    param Type
    Slope
    param Value
    2.121
    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
        2.0697
        value
        27.3836
      2. group Id
        OG001
        spread
        3.424
        value
        31.4324
    title
    BL
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.3339
        value
        31.8406
      2. group Id
        OG001
        spread
        3.4737
        value
        34.1857
    title
    6m
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.4625
        value
        26.8203
      2. group Id
        OG001
        spread
        4.095
        value
        33.2941
    title
    12m
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.7939
        value
        35.807
      2. group Id
        OG001
        spread
        4.0405
        value
        32.2807
    title
    18m
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.0875
        value
        34.625
      2. group Id
        OG001
        spread
        3.6481
        value
        33.3774
    title
    24m
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
B-type natriuretic peptide- a biomarker for heart failure (in pg/ml). 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 N-terminal Pro B-type Natriuretic Peptide
type
SECONDARY
unit Of Measure
pg/mL

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Preserved source evidence · Not medical advice