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NCT00414076 · ADVERSE EVENTS

Adverse events

Letrozole Versus Observation in Patients With Newly Diagnosed Uterine Leiomyosarcoma · Source last updated 2018-11-20

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
From study entry to time of progression or death
Other-event reporting threshold
0%

5 Participants was under observation and received no treatments

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

Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks. Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks.

0 / 44 / 40 / 4
Standard of Care

Patients receive no treatment. Follow up every 3 months.

0 / 50 / 50 / 5

Group identifiers: EG000: Letrozole · EG001: Standard of Care

Serious adverse events

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

    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
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Alopecia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Arthralgia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Bilirubin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Cholesterol
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Diarrhea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Fever w/o neutropenia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Hot Flashes
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Insomnia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Memory Impairment
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Mood Alteration (depression)
    Complete source fields
    description
    5 Participants was under observation and received no treatments
    event Groups
    1. deaths Num Affected
      0
      deaths Num At Risk
      4
      description
      Letrozole 2.5 mg Tablet By Mouth Daily for 12 Weeks. Letrozole: 2.5 mg Tablet By Mouth Daily for 12 Weeks.
      id
      EG000
      other Num Affected
      4
      other Num At Risk
      4
      serious Num Affected
      0
      serious Num At Risk
      4
      title
      Letrozole
    2. deaths Num Affected
      0
      deaths Num At Risk
      5
      description
      Patients receive no treatment. Follow up every 3 months.
      id
      EG001
      other Num Affected
      0
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      Standard of Care
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Alopecia
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Arthralgia
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Bilirubin
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Metabolism and nutrition disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Cholesterol
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Constipation
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Diarrhea
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Musculoskeletal and connective tissue disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Fatigue
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Fever w/o neutropenia
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Endocrine disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Hot Flashes
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Insomnia
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Memory Impairment
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Psychiatric disorders
      source Vocabulary
      CTCAE (3.0)
      stats
      1. group Id
        EG000
        num Affected
        2
        num At Risk
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        5
      term
      Mood Alteration (depression)
    time Frame
    From study entry to time of progression or death

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice