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NCT02717507 · OUTCOME

Proportion of Patients With Reportable Adverse Events as Described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).

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 with AE
Interval / dispersion
95% Confidence Interval
Time frame
From baseline to month 24 since baseline

What was measured

Patients with toxicities reported via CTEP-AERS and all Grade ≥ 2 adverse events (AEs) that can be attributed probably or definitely to the study drug are considered to have AEs. The proportion of patients with AEs are reported by arm with corresponding 95% confidence intervals.

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

Source class 1
Values in Proportion of patients with AE · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Carvedilol)0.0267Not reported0.00830.1125Not reported
Arm II (Placebo)0Not reported00.039Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0083
        upper Limit
        0.1125
        value
        0.0267
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        0.039
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      75
    2. group Id
      OG001
      value
      76
    units
    Participants
description
Patients with toxicities reported via CTEP-AERS and all Grade ≥ 2 adverse events (AEs) that can be attributed probably or definitely to the study drug are considered to have AEs. The proportion of patients with AEs are reported by arm with corresponding 95% confidence intervals.
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
From baseline to month 24 since baseline
title
Proportion of Patients With Reportable Adverse Events as Described in the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).
type
SECONDARY
unit Of Measure
Proportion of patients with AE

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice