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NCT02228681 · ADVERSE EVENTS

Adverse events

Everolimus and Letrozole or Hormonal Therapy to Treat Endometrial Cancer · Source last updated 2024-09-19

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
up to 30 days after the last cycle.
Other-event reporting threshold
0%

Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.

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

Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.

13 / 3737 / 3713 / 37
Tamoxifen and Medroxyprogesterone Acetate

Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.

10 / 3636 / 3620 / 36

Group identifiers: EG000: Everolimus and Letrozole · EG001: Tamoxifen and Medroxyprogesterone Acetate

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Pericardial Effusion
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular Tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Ileus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Cholecystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Kidney Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Lung Infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Sepsis

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Blood And Lymphatic System Disorders - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      36
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Palpitations
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Heart Failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Cardiac Disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Pericardial Effusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Sinus Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Vertigo
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Tinnitus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Hearing Impaired
Complete source fields
description
Collected on a 28 day cycle while treatment continues and then up to 30 days after the last cycle.
event Groups
  1. deaths Num Affected
    13
    deaths Num At Risk
    37
    description
    Everolimus 10 mg daily plus letrozole 2.5 mg PO daily in a 28 day cycle.
    id
    EG000
    other Num Affected
    37
    other Num At Risk
    37
    serious Num Affected
    13
    serious Num At Risk
    37
    title
    Everolimus and Letrozole
  2. deaths Num Affected
    20
    deaths Num At Risk
    36
    description
    Tamoxifen 20 mg PO bid days 1-28 plus medroxyprogesterone acetate 200 mg PO days 8-14 and 22-28 repeating in a 28 day cycle.
    id
    EG001
    other Num Affected
    36
    other Num At Risk
    36
    serious Num Affected
    10
    serious Num At Risk
    36
    title
    Tamoxifen and Medroxyprogesterone Acetate
frequency Threshold
0
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Blood And Lymphatic System Disorders - Other
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      36
    term
    Anemia
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Atrial Fibrillation
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular Tachycardia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Palpitations
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Heart Failure
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Cardiac Disorders - Other
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Pericardial Effusion
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Sinus Tachycardia
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Vertigo
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Tinnitus
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Hearing Impaired
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Anemia
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Pericardial Effusion
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Supraventricular Tachycardia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Ascites
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Diarrhea
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Ileus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Nausea
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Fever
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Cholecystitis
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      36
    term
    Kidney Infection
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Lung Infection
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      37
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      36
    term
    Sepsis
time Frame
up to 30 days after the last cycle.

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