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NCT00553410 · ADVERSE EVENTS

Adverse events

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer · Source last updated 2026-09-01

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
during or within 30 days after stopping study treatment
Other-event reporting threshold
0%

Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Continuous Letrozole

Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously

1004 / 24112257 / 2411170 / 2426
Arm B: Intermittent Letrozole

Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months

1052 / 24172261 / 2417146 / 2425

Group identifiers: EG000: Arm A: Continuous Letrozole · EG001: Arm B: Intermittent 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
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2417
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Cardiac Arrhythmia-Other (Specify)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      2417
    term
    Cardiac-ischemia/infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Left ventricular diastolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      2417
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Pain - Cardiac/heart
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Pericardial effusion (non-malignant)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Right ventricular dysfunction (cor pulmonale)

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
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      2417
    term
    Cardiac-ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1025
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      954
      num At Risk
      2417
    term
    Fatigue (asthenia, lethargy, malaise)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      136
      num At Risk
      2417
    term
    Fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      2417
    term
    Thrombosis/embolism (vascular access-related)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1113
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1119
      num At Risk
      2417
    term
    Osteoporosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      634
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      613
      num At Risk
      2417
    term
    Pain - Bone
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1506
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1453
      num At Risk
      2417
    term
    Pain - Joint
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      841
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      818
      num At Risk
      2417
    term
    Pain - Muscle
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      2417
    term
    Hemorrhage, CNS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      2417
    term
    CNS cerebrovascular ischemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      983
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      961
      num At Risk
      2417
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      767
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      762
      num At Risk
      2417
    term
    Mood alteration - depression
Complete source fields
description
Adverse event is defined as any untoward medical occurrence that occurs from the first dose of study medication until 30 days after final dose, regardless of whether it is considered related to a medication. Any known untoward event that occurs subsequent to the adverse event reporting period that the investigator assesses as possibly related to the protocol treatment should be considered an adverse event. Symptoms of the targeted cancer (if applicable) should not be reported as adverse events.
event Groups
  1. deaths Num Affected
    170
    deaths Num At Risk
    2426
    description
    Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
    id
    EG000
    other Num Affected
    2257
    other Num At Risk
    2411
    serious Num Affected
    1004
    serious Num At Risk
    2411
    title
    Arm A: Continuous Letrozole
  2. deaths Num Affected
    146
    deaths Num At Risk
    2425
    description
    Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
    id
    EG001
    other Num Affected
    2261
    other Num At Risk
    2417
    serious Num Affected
    1052
    serious Num At Risk
    2417
    title
    Arm B: Intermittent Letrozole
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      2417
    term
    Cardiac-ischemia/infarction
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1025
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      954
      num At Risk
      2417
    term
    Fatigue (asthenia, lethargy, malaise)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      148
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      136
      num At Risk
      2417
    term
    Fracture
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      2417
    term
    Thrombosis/embolism (vascular access-related)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1113
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1119
      num At Risk
      2417
    term
    Osteoporosis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      634
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      613
      num At Risk
      2417
    term
    Pain - Bone
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1506
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1453
      num At Risk
      2417
    term
    Pain - Joint
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      841
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      818
      num At Risk
      2417
    term
    Pain - Muscle
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      2417
    term
    Hemorrhage, CNS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      2417
    term
    CNS cerebrovascular ischemia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      983
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      961
      num At Risk
      2417
    term
    Insomnia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      767
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      762
      num At Risk
      2417
    term
    Mood alteration - depression
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2417
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Cardiac Arrhythmia-Other (Specify)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      2417
    term
    Cardiac-ischemia/infarction
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - AV block-2nd degree Mobitz Type I (Wenckebach)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block)
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      2417
    term
    Conduction abnormality/Atrioventricular heart block - Wolff-Parkinson-White syndrome
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Left ventricular diastolic dysfunction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      2417
    term
    Left ventricular systolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Pain - Cardiac/heart
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      2417
    term
    Pericardial effusion (non-malignant)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Restrictive cardiomyopathy
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    NCI CTCAE V.3
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2411
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      2417
    term
    Right ventricular dysfunction (cor pulmonale)
time Frame
during or within 30 days after stopping study treatment

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