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NCT00382070 · ADVERSE EVENTS

Adverse events

Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer · Source last updated 2024-03-22

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
Not reported
Other-event reporting threshold
5%

Participants at Risk includes any patient who submitted an AE form.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo

Placebo

87 / 1938336 / 1938Not reported / Not reported
Letrozole

Letrozole

80 / 1951400 / 1951Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Letrozole

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Adult respiratory distress syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Alanine aminotransferase increased (ALT/SGPT)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Amnesia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Aortic injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Aspartate aminotransferase increased (AST/SGOT)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Aspiration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Bladder infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1951
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Cardiac disorders - Other, specify

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      302
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      347
      num At Risk
      1951
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      1951
    term
    Myalgia
Complete source fields
description
Participants at Risk includes any patient who submitted an AE form.
event Groups
  1. description
    Placebo
    id
    EG000
    other Num Affected
    336
    other Num At Risk
    1938
    serious Num Affected
    87
    serious Num At Risk
    1938
    title
    Placebo
  2. description
    Letrozole
    id
    EG001
    other Num Affected
    400
    other Num At Risk
    1951
    serious Num Affected
    80
    serious Num At Risk
    1951
    title
    Letrozole
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      302
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      347
      num At Risk
      1951
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      118
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      1951
    term
    Myalgia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Adult respiratory distress syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Alanine aminotransferase increased (ALT/SGPT)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Amnesia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1951
    term
    Aortic injury
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Aspartate aminotransferase increased (AST/SGOT)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Aspiration
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Bladder infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1951
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1951
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE v4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1938
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1951
    term
    Cardiac disorders - Other, specify

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