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NCT02717507 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Up to 24 months after first dose of drug
Other-event reporting threshold
0%

Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Carvedilol)

Patients receive low-dose carvedilol orally (PO) once daily (QD) or twice daily (BID) for 24 months.

0 / 892 / 890 / 89
Arm II (Placebo)

Patients receive placebo PO QD or BID for 24 months.

0 / 930 / 930 / 93

Group identifiers: EG000: Arm I (Carvedilol) · EG001: Arm II (Placebo)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        89
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        93
      term
      Dyspnea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        89
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        93
      term
      Arthralgia
    Complete source fields
    description
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      89
      description
      Patients receive low-dose carvedilol orally (PO) once daily (QD) or twice daily (BID) for 24 months.
      id
      EG000
      other Num Affected
      2
      other Num At Risk
      89
      serious Num Affected
      0
      serious Num At Risk
      89
      title
      Arm I (Carvedilol)
    2. deaths Num Affected
      0
      deaths Num At Risk
      93
      description
      Patients receive placebo PO QD or BID for 24 months.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      93
      serious Num Affected
      0
      serious Num At Risk
      93
      title
      Arm II (Placebo)
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Respiratory, thoracic and mediastinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        89
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        93
      term
      Dyspnea
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        89
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        93
      term
      Arthralgia
    time Frame
    Up to 24 months after first dose of drug

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

    Preserved source evidence · Not medical advice