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NCT00569582 · ADVERSE EVENTS

Adverse events

A Study of the Efficacy and Safety of CORLUX in the Treatment of Endogenous Cushing's Syndrome · Source last updated 2013-08-22

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
24 weeks
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Mifepristone

Mifepristone was administered at doses of 300-1200 mg daily.

16 / 5049 / 50Not reported / Not reported

Group identifiers: EG000: Mifepristone

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
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Legionella pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Gastritis Erosive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Foot Fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Intracranial Aneurysm
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Orthostatic Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      2
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    term
    Respiratory Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Confusional State
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Blood Potassium Decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Renal Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Pulmonary Oedema

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
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      50
      num Events
      40
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      50
      num Events
      21
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      50
      num Events
      12
    term
    Dry mouth
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
      num Events
      8
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
      num Events
      5
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      50
      num Events
      4
    term
    Gastrooesophageal reflux disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      50
      num Events
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      50
      num Events
      31
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      50
      num Events
      9
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    mild
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      5
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      4
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      6
    term
    Oedema
Complete source fields
event Groups
  1. description
    Mifepristone was administered at doses of 300-1200 mg daily.
    id
    EG000
    other Num Affected
    49
    other Num At Risk
    50
    serious Num Affected
    16
    serious Num At Risk
    50
    title
    Mifepristone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      50
      num Events
      40
    term
    Nausea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      50
      num Events
      21
    term
    Vomiting
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      50
      num Events
      12
    term
    Dry mouth
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      50
      num Events
      8
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      50
      num Events
      5
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      50
      num Events
      4
    term
    Gastrooesophageal reflux disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      50
      num Events
      37
    term
    Fatigue
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      50
      num Events
      31
    term
    Oedema peripheral
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      50
      num Events
      9
    term
    Pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    mild
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      5
    term
    Asthenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      4
    term
    Malaise
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      50
      num Events
      6
    term
    Oedema
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Legionella pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Gastritis Erosive
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Foot Fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Intracranial Aneurysm
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Orthostatic Hypotension
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      2
    term
    Dyspnoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      50
      num Events
      2
    term
    Respiratory Failure
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Confusional State
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Blood Potassium Decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Renal Failure Acute
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    MEDRA
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      50
      num Events
      1
    term
    Pulmonary Oedema
time Frame
24 weeks

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