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NCT03862131 · ADVERSE EVENTS

Adverse events

PROactive Evaluation of Function to Avoid CardioToxicity · Source last updated 2025-07-29

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
Adverse events and all-cause mortality will be tracked from time of consent to the last study visit (up to 36 months).
Other-event reporting threshold
0%

Only adverse events in relation to the study procedures will be documented and reported. These include adverse events occurring from the MRI scanner, SENC MyoStrain® Testing Software, or breach of confidentiality.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
MyoStrain® Unblinded Treatment Arm

* After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \>-10% or 9 or more segments \>-17% for entrance into the study as the Higher Risk Group * The unblinded treatment arm will enhance patient management by augmenting standard of care with serial MyoStrain® monitoring of the impact of cancer therapy on myocardial function. * Higher Risk unblinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.

0 / 251 / 254 / 25
MyoStrain® Blinded Control Arm

* After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \>-10% or 9 or more segments \>-17% for entrance into the study as the Higher Risk group * The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care * Higher Risk blinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.

0 / 181 / 184 / 18
Non-randomized

-Patients were enrolled but not randomized to either arm.

0 / 60 / 60 / 6

Group identifiers: EG000: MyoStrain® Unblinded Treatment Arm · EG001: MyoStrain® Blinded Control Arm · EG002: Non-randomized

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
      Psychiatric disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        25
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
      3. group Id
        EG002
        num At Risk
        6
      term
      Anxiety
    Complete source fields
    description
    Only adverse events in relation to the study procedures will be documented and reported. These include adverse events occurring from the MRI scanner, SENC MyoStrain® Testing Software, or breach of confidentiality.
    event Groups
    1. deaths Num Affected
      4
      deaths Num At Risk
      25
      description
      * After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \>-10% or 9 or more segments \>-17% for entrance into the study as the Higher Risk Group * The unblinded treatment arm will enhance patient management by augmenting standard of care with serial MyoStrain® monitoring of the impact of cancer therapy on myocardial function. * Higher Risk unblinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.
      id
      EG000
      other Num Affected
      1
      other Num At Risk
      25
      serious Num Affected
      0
      serious Num At Risk
      25
      title
      MyoStrain® Unblinded Treatment Arm
    2. deaths Num Affected
      4
      deaths Num At Risk
      18
      description
      * After consenting to the PROACT study, patients will undergo a baseline MRI to determine their risk stratification for the study. This baseline MyoStrain® MRI must demonstrate 2 or more segments measuring \>-10% or 9 or more segments \>-17% for entrance into the study as the Higher Risk group * The blinded control arm will provide investigators with LVEF and LVEDV/LVESV measurements, which are clinical, in conjunction with standard of care * Higher Risk blinded patients will continue to undergo MyoStrain® MRI testing, regardless of study arm, at 1 month (+1 week), 3 months (+ 1 week), 6 months (+1 week), 12 months (+ 30 days), 24 months (+30 days), and 36 months (+30 days) after the baseline visit. * In addition to the MyoStrain® testing, patients will also be asked to complete a brief patient satisfaction questionnaire at each PROACT time point.
      id
      EG001
      other Num Affected
      1
      other Num At Risk
      18
      serious Num Affected
      0
      serious Num At Risk
      18
      title
      MyoStrain® Blinded Control Arm
    3. deaths Num Affected
      0
      deaths Num At Risk
      6
      description
      -Patients were enrolled but not randomized to either arm.
      id
      EG002
      other Num Affected
      0
      other Num At Risk
      6
      serious Num Affected
      0
      serious Num At Risk
      6
      title
      Non-randomized
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        25
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        18
      3. group Id
        EG002
        num At Risk
        6
      term
      Anxiety
    time Frame
    Adverse events and all-cause mortality will be tracked from time of consent to the last study visit (up to 36 months).

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

    Preserved source evidence · Not medical advice