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NCT03422198 · ADVERSE EVENTS

Adverse events

Short Course Vaginal Cuff Brachytherapy in Treating Participants With Stage I-II Endometrial Cancer · Source last updated 2025-12-12

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
12 months after start of brachytherapy
Other-event reporting threshold
0%

Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Experimental: Short Course Vaginal Cuff Brachytherapy

Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.

2 / 5446 / 542 / 54
Control: Standard of Care Vaginal Cuff Brachytherapy

Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.

2 / 5450 / 541 / 54

Group identifiers: EG000: Experimental: Short Course Vaginal Cuff Brachytherapy · EG001: Control: Standard of Care Vaginal Cuff Brachytherapy

Serious 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
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Cardiac disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Hypoxia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Pneumonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Skin infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      2
    term
    Wound dehiscence

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 (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Abdominal Distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      10
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      3
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
      num Events
      7
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Atelectasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Bloating
Complete source fields
description
Routine safety and tolerability were evaluated at each study visit from the results of reported signs and symptoms, scheduled physical examinations, vital sign measurements, and clinical laboratory test results. Information about all adverse events, whether volunteered by the participant, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, was collected, recorded and followed as appropriate.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    54
    description
    Participants undergo short course vaginal cuff brachytherapy for 2 fractions with 1 week apart.
    id
    EG000
    other Num Affected
    46
    other Num At Risk
    54
    serious Num Affected
    2
    serious Num At Risk
    54
    title
    Experimental: Short Course Vaginal Cuff Brachytherapy
  2. deaths Num Affected
    1
    deaths Num At Risk
    54
    description
    Participants undergo standard of care vaginal cuff brachytherapy for 3-5 fractions over no more than 3 weeks.
    id
    EG001
    other Num Affected
    50
    other Num At Risk
    54
    serious Num Affected
    2
    serious Num At Risk
    54
    title
    Control: Standard of Care Vaginal Cuff Brachytherapy
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Abdominal Distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
      num Events
      5
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
      num Events
      10
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Acute kidney injury
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      54
      num Events
      4
    term
    Allergic reaction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
      num Events
      2
    term
    Alopecia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Anemia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      54
      num Events
      3
    term
    Anorexia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Anxiety
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
      num Events
      7
    term
    Arthralgia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Atelectasis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Back Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Bloating
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Cardiac disorders - Other, specify
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Hypotension
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Hypoxia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      1
    term
    Pneumonitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Sepsis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
      num Events
      0
    term
    Skin infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      54
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
      num Events
      2
    term
    Wound dehiscence
time Frame
12 months after start of brachytherapy

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