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NCT01991808 · ADVERSE EVENTS

Adverse events

Suitability of DCE-MRI for Detection of Vascular Changes After VBT · Source last updated 2019-11-26

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
Not reported
Other-event reporting threshold
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DCE-MRI

Radiotherapy

0 / 1610 / 160 / 16

Group identifiers: EG000: DCE-MRI

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
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Abdominal distention
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Abdominal pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      term
      Anorexia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Constipation
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Diarrhea
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        5
      term
      Fatigue
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Fever
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Infection, Pelvis NOS
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Palpitations
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Urethral pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        4
      term
      Urinary frequency
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Urinary incontinence
    Complete source fields
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      16
      description
      Radiotherapy
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      16
      serious Num Affected
      0
      serious Num At Risk
      16
      title
      DCE-MRI
    frequency Threshold
    0
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Abdominal distention
    2. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Abdominal pain
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
      term
      Anorexia
    4. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Constipation
    5. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        16
        num Events
        2
      term
      Diarrhea
    6. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        5
      term
      Fatigue
    7. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Fever
    8. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Infection, Pelvis NOS
    9. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Palpitations
    10. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Urethral pain
    11. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        16
        num Events
        4
      term
      Urinary frequency
    12. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        16
        num Events
        1
      term
      Urinary incontinence

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

    Preserved source evidence · Not medical advice