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NCT00282087 · ADVERSE EVENTS

Adverse events

Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma · Source last updated 2014-12-01

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
4%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Women Treated With Adjuvant Regimen for High Risk Uterine LMS

Not reported

9 / 4714 / 47Not reported / Not reported

Group identifiers: EG000: Women Treated With Adjuvant Regimen for High Risk Uterine LMS

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Perforation of bowel
  2. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Hernia
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Colostomy Reversal
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Chest Pain
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Neutropenia
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Neutrophils
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Diarrhea
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Throat Pain
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Bilirubin
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Platelets
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Fever
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Infection

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      47
    term
    myelosuppression
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      47
    term
    Hypersensitivity
  3. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    neuropathy
  4. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    term
    Edema
Complete source fields
event Groups
  1. id
    EG000
    other Num Affected
    14
    other Num At Risk
    47
    serious Num Affected
    9
    serious Num At Risk
    47
    title
    Women Treated With Adjuvant Regimen for High Risk Uterine LMS
frequency Threshold
4
other Events
  1. organ System
    Endocrine disorders
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      47
    term
    myelosuppression
  2. organ System
    Immune system disorders
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      47
    term
    Hypersensitivity
  3. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      47
    term
    neuropathy
  4. organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
    term
    Edema
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Perforation of bowel
  2. organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Hernia
  3. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Colostomy Reversal
  4. organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Chest Pain
  5. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Neutropenia
  6. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      47
      num Events
      2
    term
    Neutrophils
  7. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Diarrhea
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Throat Pain
  9. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Bilirubin
  10. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Platelets
  11. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Fever
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      47
      num Events
      1
    term
    Infection

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Preserved source evidence · Not medical advice