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NCT00381888 · ADVERSE EVENTS

Adverse events

Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer · Source last updated 2017-12-28

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
4 Weeks
Other-event reporting threshold
0%

33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
All Patients Who Received at Least One Dose of Fondaparinux

This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.

7 / 3323 / 33Not reported / Not reported

Group identifiers: EG000: All Patients Who Received at Least One Dose of Fondaparinux

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
    notes
    Grade 5, death
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, severe
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Colitis (C. difficile)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5, death
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Infection/Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, moderate
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Partial small bowel obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, severe
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Port-a-cath infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4, life-threatening
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pulmonary embolism, post-op
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5, death
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4, life threatening
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Small bowel obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, moderate
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Wound 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. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Anxiety, increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Atelectasis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
      num Events
      7
    term
    Bruising
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Cold sensation, upper thighs & lower abdomen
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Decreased appetite (anorexia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dehyration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dysuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Emesis (vomiting)
Complete source fields
description
33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
event Groups
  1. description
    This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
    id
    EG000
    other Num Affected
    23
    other Num At Risk
    33
    serious Num Affected
    7
    serious Num At Risk
    33
    title
    All Patients Who Received at Least One Dose of Fondaparinux
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Anxiety, increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Atelectasis
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Bradycardia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      33
      num Events
      7
    term
    Bruising
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Chills
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Cold sensation, upper thighs & lower abdomen
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Decreased appetite (anorexia)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dehyration
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      2
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dyspnea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Dysuria
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      33
      num Events
      4
    term
    Emesis (vomiting)
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5, death
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Cardiac ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, severe
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Colitis (C. difficile)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5, death
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Infection/Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, moderate
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Partial small bowel obstruction
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 3, severe
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Port-a-cath infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4, life-threatening
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Pulmonary embolism, post-op
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 5, death
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Respiratory failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4, life threatening
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Small bowel obstruction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 2, moderate
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      33
      num Events
      1
    term
    Wound infection
time Frame
4 Weeks

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Preserved source evidence · Not medical advice