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NCT00066690 · ADVERSE EVENTS

Adverse events

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer · Source last updated 2026-08-26

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 month until year 6. Reported at a median follow-up of 67 months.
Other-event reporting threshold
0%

Targeted AEs and other grade 3 or higher AEs 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
Tamoxifen

Tamoxifen 20mg orally daily for 5 years

315 / 1007951 / 100787 / 1007
T+OFS

Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

375 / 1007982 / 100768 / 1007
E+OFS

Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)

375 / 1001980 / 100180 / 1001

Group identifiers: EG000: Tamoxifen · EG001: T+OFS · EG002: 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
      2
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1001
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1001
    term
    Cardiac Arrhythmia-Other (Specify)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1001
    term
    Cardiac-ischemia/infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Left ventricular diastolic dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1001
    term
    Left ventricular systolic dysfunction
  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
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Pain - Cardiac/heart
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Restrictive cardiomyopathy
  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
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Right ventricular dysfunction (cor pulmonale)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    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
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1001
    term
    Supraventricular and nodal arrhythmia - Sinus arrhythmia

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
      1
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      1001
    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
      239
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      215
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      228
      num At Risk
      1001
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      571
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      595
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      591
      num At Risk
      1001
    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
      4
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      84
      num At Risk
      1001
    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
      31
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      1001
    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
      41
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      1001
    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
      5
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1001
    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
      15
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      1001
    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
      15
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      1001
    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
      123
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      198
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      316
      num At Risk
      1001
    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
      631
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      700
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      778
      num At Risk
      1001
    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
      14
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      1001
    term
    Hemorrhage, CNS
Complete source fields
description
Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.
event Groups
  1. deaths Num Affected
    87
    deaths Num At Risk
    1007
    description
    Tamoxifen 20mg orally daily for 5 years
    id
    EG000
    other Num Affected
    951
    other Num At Risk
    1007
    serious Num Affected
    315
    serious Num At Risk
    1007
    title
    Tamoxifen
  2. deaths Num Affected
    68
    deaths Num At Risk
    1007
    description
    Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    EG001
    other Num Affected
    982
    other Num At Risk
    1007
    serious Num Affected
    375
    serious Num At Risk
    1007
    title
    T+OFS
  3. deaths Num Affected
    80
    deaths Num At Risk
    1001
    description
    Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
    id
    EG002
    other Num Affected
    980
    other Num At Risk
    1001
    serious Num Affected
    375
    serious Num At Risk
    1001
    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
      1
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      1001
    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
      239
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      215
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      228
      num At Risk
      1001
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      571
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      595
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      591
      num At Risk
      1001
    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
      4
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      84
      num At Risk
      1001
    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
      31
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      46
      num At Risk
      1001
    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
      41
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      51
      num At Risk
      1001
    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
      5
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1001
    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
      15
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      1001
    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
      15
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      28
      num At Risk
      1001
    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
      123
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      198
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      316
      num At Risk
      1001
    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
      631
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      700
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      778
      num At Risk
      1001
    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
      14
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      1001
    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
      2
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      1001
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1001
    term
    Cardiac Arrhythmia-Other (Specify)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1001
    term
    Cardiac-ischemia/infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Left ventricular diastolic dysfunction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      1001
    term
    Left ventricular systolic dysfunction
  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
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Pain - Cardiac/heart
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Restrictive cardiomyopathy
  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
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    term
    Right ventricular dysfunction (cor pulmonale)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1001
    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
      0
      num At Risk
      1007
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1007
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1001
    term
    Supraventricular and nodal arrhythmia - Sinus arrhythmia
time Frame
Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.

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Preserved source evidence · Not medical advice