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NCT02104895 · ADVERSE EVENTS

Adverse events

Accelerated Partial Breast Irradiation Using Intensity Modulated Radiotherapy Versus Whole Breast Irradiation · Source last updated 2016-08-11

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
5-years
Other-event reporting threshold
5%

Acute and late skin toxicity, any grade

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Whole Breast Irradiation (WBI)

Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)

0 / 260173 / 260Not reported / Not reported
Partial Breast Irradiation (APBI)

Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)

0 / 24649 / 246Not reported / Not reported

Group identifiers: EG000: Whole Breast Irradiation (WBI) · EG001: Partial Breast Irradiation (APBI)

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
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Here we report total rate of acute skin toxicity in each arm of the study
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        173
        num At Risk
        260
      2. group Id
        EG001
        num Affected
        49
        num At Risk
        246
      term
      acute skin toxicity, any grade
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Here we report rate of late skin toxicity in each arm of the study
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        29
        num At Risk
        260
      2. group Id
        EG001
        num Affected
        11
        num At Risk
        246
      term
      late skin toxicity, any grade
    Complete source fields
    description
    Acute and late skin toxicity, any grade
    event Groups
    1. description
      Conventional whole breast irradiation (WBI) Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)
      id
      EG000
      other Num Affected
      173
      other Num At Risk
      260
      serious Num Affected
      0
      serious Num At Risk
      260
      title
      Whole Breast Irradiation (WBI)
    2. description
      Accelerated partial breast irradiation (APBI) Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
      id
      EG001
      other Num Affected
      49
      other Num At Risk
      246
      serious Num Affected
      0
      serious Num At Risk
      246
      title
      Partial Breast Irradiation (APBI)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Here we report total rate of acute skin toxicity in each arm of the study
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        173
        num At Risk
        260
      2. group Id
        EG001
        num Affected
        49
        num At Risk
        246
      term
      acute skin toxicity, any grade
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      notes
      Here we report rate of late skin toxicity in each arm of the study
      organ System
      Skin and subcutaneous tissue disorders
      stats
      1. group Id
        EG000
        num Affected
        29
        num At Risk
        260
      2. group Id
        EG001
        num Affected
        11
        num At Risk
        246
      term
      late skin toxicity, any grade
    time Frame
    5-years

    Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

    Preserved source evidence · Not medical advice