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NCT00066703 · ADVERSE EVENTS

Adverse events

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-02-06

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
Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.
Other-event reporting threshold
0%

Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
T+OFS

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

484 / 13211293 / 1321Not reported / Not reported
E+OFS

Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

496 / 13171298 / 1317Not reported / Not reported

Group identifiers: EG000: T+OFS · EG001: E+OFS

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Blood/Bone Marrow-Other (Specify)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1317
    term
    Hemoglobin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Cardiac Arrhythmia-Other (Specify)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1317
    term
    Cardiac-ischemia/infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Left ventricular diastolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Pain - Cardiac/heart
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1317
    term
    Supraventricular and nodal arrhythmia - Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Supraventricular and nodal arrhythmia - Sinus tachycardia

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
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1317
    term
    Cardiac-ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      446
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      478
      num At Risk
      1317
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      807
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      760
      num At Risk
      1317
    term
    Fatigue (asthenia, lethargy, malaise)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      1317
    term
    Injection site reaction/extravasation changes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      1317
    term
    Allergic reaction/hypersensitivity (including drug fever)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      1317
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1317
    term
    Thrombosis/embolism (vascular access-related)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      1317
    term
    Glucose, serum-high (hyperglycemia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      1317
    term
    Pancreatic endocrine: glucose intolerance
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      388
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      588
      num At Risk
      1317
    term
    Osteoporosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      953
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1030
      num At Risk
      1317
    term
    Pain - Joint
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      1317
    term
    Hemorrhage, CNS
Complete source fields
description
Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
event Groups
  1. description
    Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
    id
    EG000
    other Num Affected
    1293
    other Num At Risk
    1321
    serious Num Affected
    484
    serious Num At Risk
    1321
    title
    T+OFS
  2. description
    Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
    id
    EG001
    other Num Affected
    1298
    other Num At Risk
    1317
    serious Num Affected
    496
    serious Num At Risk
    1317
    title
    E+OFS
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1317
    term
    Cardiac-ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      446
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      478
      num At Risk
      1317
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      807
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      760
      num At Risk
      1317
    term
    Fatigue (asthenia, lethargy, malaise)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      1317
    term
    Injection site reaction/extravasation changes
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      1317
    term
    Allergic reaction/hypersensitivity (including drug fever)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      1317
    term
    Fracture
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1317
    term
    Thrombosis/embolism (vascular access-related)
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      31
      num At Risk
      1317
    term
    Glucose, serum-high (hyperglycemia)
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      1317
    term
    Pancreatic endocrine: glucose intolerance
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      388
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      588
      num At Risk
      1317
    term
    Osteoporosis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      953
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1030
      num At Risk
      1317
    term
    Pain - Joint
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      1317
    term
    Hemorrhage, CNS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Blood/Bone Marrow-Other (Specify)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1317
    term
    Hemoglobin
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Cardiac Arrhythmia-Other (Specify)
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      1317
    term
    Cardiac-ischemia/infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Left ventricular diastolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1317
    term
    Pain - Cardiac/heart
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1317
    term
    Supraventricular and nodal arrhythmia - Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      1321
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1317
    term
    Supraventricular and nodal arrhythmia - Sinus tachycardia
time Frame
Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months.

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