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NCT00309946 · ADVERSE EVENTS

Adverse events

Cediranib Maleate in Treating Patients With Malignant Mesothelioma That Cannot Be Removed By Surgery · Source last updated 2014-07-31

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
After completion of study treatment, patients are followed for up to 8 weeks.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment (Enzyme Inhibitor Therapy)

Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.

31 / 5149 / 51Not reported / Not reported

Group identifiers: EG000: Treatment (Enzyme Inhibitor Therapy)

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
    Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its outward expansion beyond the normal girth of the stomach and waist.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the abdominal region
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of alanine aminotransferase, indicative of liver damage or disease.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Anaphylaxis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anorexia is the decreased sensation of appetite.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of aspartate aminotransferase (AST)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Atelectasis is defined as the collapse or closure of the lung resulting in reduced or absent gas exchange.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Atelectasis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Atrial flutter (AFL) is an abnormal heart rhythm that occurs in the atria of the heart.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Bronchopulmonary hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cardiac arrest, also known as cardiopulmonary arrest or circulatory arrest, is the cessation of normal circulation of the blood due to failure of the heart to contract effectively.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the chest wall not attributed to any cardiac disorder.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Chest wall pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A disorder characterized by a conspicuous change in cognitive function.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Cognitive disturbance

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
    notes
    Pain in the abdominal region.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of alanine aminotransferase, indicative of liver damage or disease.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    term
    Alanine aminotransferase (ALT) increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of Alkaline phosphatase
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    term
    Alkaline phosphatase (ALP) increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Allergic rhinitis is an allergic inflammation of the nasal airways.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Allergic rhinitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anemia is a decrease in number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anorexia is the decreased sensation of appetite.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      51
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anxiety is an unpleasant state of inner turmoil and apprehension, often accompanied by nervous behavior, such as pacing back and forth, somatic complaints and rumination.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    term
    Anxiety
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Joint pain.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of aspartate aminotransferase (AST)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
    term
    Aspartate aminotransferase (AST) increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the back.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in chest wall
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Chest wall pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      51
    term
    Constipation
Complete source fields
event Groups
  1. description
    Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    51
    serious Num Affected
    31
    serious Num At Risk
    51
    title
    Treatment (Enzyme Inhibitor Therapy)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the abdominal region.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      51
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of alanine aminotransferase, indicative of liver damage or disease.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      51
    term
    Alanine aminotransferase (ALT) increased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of Alkaline phosphatase
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      51
    term
    Alkaline phosphatase (ALP) increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Allergic rhinitis is an allergic inflammation of the nasal airways.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Allergic rhinitis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anemia is a decrease in number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood.
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Anemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anorexia is the decreased sensation of appetite.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      51
    term
    Anorexia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anxiety is an unpleasant state of inner turmoil and apprehension, often accompanied by nervous behavior, such as pacing back and forth, somatic complaints and rumination.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      51
    term
    Anxiety
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Joint pain.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      51
    term
    Arthralgia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of aspartate aminotransferase (AST)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
    term
    Aspartate aminotransferase (AST) increased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the back.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      51
    term
    Back pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in chest wall
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      51
    term
    Chest wall pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      51
    term
    Constipation
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its outward expansion beyond the normal girth of the stomach and waist.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal distension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the abdominal region
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Abdominal pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of alanine aminotransferase, indicative of liver damage or disease.
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death.
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Anaphylaxis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Anorexia is the decreased sensation of appetite.
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Increased levels of aspartate aminotransferase (AST)
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Atelectasis is defined as the collapse or closure of the lung resulting in reduced or absent gas exchange.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Atelectasis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Atrial flutter (AFL) is an abnormal heart rhythm that occurs in the atria of the heart.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma.
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Bronchopulmonary hemorrhage
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Cardiac arrest, also known as cardiopulmonary arrest or circulatory arrest, is the cessation of normal circulation of the blood due to failure of the heart to contract effectively.
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Pain in the chest wall not attributed to any cardiac disorder.
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      51
    term
    Chest wall pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    A disorder characterized by a conspicuous change in cognitive function.
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      51
    term
    Cognitive disturbance
time Frame
After completion of study treatment, patients are followed for up to 8 weeks.

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