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NCT01399658 · ADVERSE EVENTS

Adverse events

Image-Guided Gynecologic Brachytherapy · Source last updated 2023-03-14

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
From registration to 90 days post-procedure, up to 15 months.
Other-event reporting threshold
0%

Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Image-Guided Brachytherapy

Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer

0 / 9386 / 93Not reported / Not reported

Group identifiers: EG000: Image-Guided Brachytherapy

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
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        93
      term
      Abdominal pain
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        93
      term
      Acidosis
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Activated partial thrombop
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        93
      term
      Acute kidney injury
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alanine aminotransferase i
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        93
      term
      Alkaline phosphatase incre
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alkalosis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alopecia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Anal hemorrhage
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        71
        num At Risk
        93
      term
      Anemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        93
      term
      Anorexia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        93
      term
      Anxiety
    Complete source fields
    description
    Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
    event Groups
    1. description
      Image-guided brachytherapy Image-guided brachytherapy: MRI-guided application of brachytherapy 3'-Deoxy-3'-18f-Fluorothymidine: Assessing tumor proliferation in Gynecologic cancer
      id
      EG000
      other Num Affected
      86
      other Num At Risk
      93
      serious Num Affected
      0
      serious Num At Risk
      93
      title
      Image-Guided Brachytherapy
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        21
        num At Risk
        93
      term
      Abdominal pain
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        93
      term
      Acidosis
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Activated partial thrombop
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Renal and urinary disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        5
        num At Risk
        93
      term
      Acute kidney injury
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alanine aminotransferase i
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Investigations
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        93
      term
      Alkaline phosphatase incre
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alkalosis
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Alopecia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        93
      term
      Anal hemorrhage
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        71
        num At Risk
        93
      term
      Anemia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        93
      term
      Anorexia
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        93
      term
      Anxiety
    time Frame
    From registration to 90 days post-procedure, up to 15 months.

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

    Preserved source evidence · Not medical advice