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NCT03189446 · ADVERSE EVENTS

Adverse events

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer · Source last updated 2024-03-08

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
Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Vaginal Cuff Brachytherapy + Chemotherapy

Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

0 / 3210 / 321 / 32

Group identifiers: EG000: Vaginal Cuff Brachytherapy + Chemotherapy

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
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        32
      term
      Taxol Reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Anemia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Peripheral Neuropathy
    Complete source fields
    event Groups
    1. deaths Num Affected
      1
      deaths Num At Risk
      32
      description
      Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      32
      serious Num Affected
      0
      serious Num At Risk
      32
      title
      Vaginal Cuff Brachytherapy + Chemotherapy
    frequency Threshold
    5
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Fatigue
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Diarrhea
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Immune system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        32
      term
      Taxol Reaction
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Blood and lymphatic system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Anemia
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAE (4.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        32
      term
      Peripheral Neuropathy
    time Frame
    Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.

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

    Preserved source evidence · Not medical advice