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NCT00075764 · ADVERSE EVENTS

Adverse events

S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer · Source last updated 2021-01-13

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
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.
Other-event reporting threshold
5%

Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

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

Patients receive oral anastrozole once daily on days 1-28

21 / 337309 / 337Not reported / Not reported
Anastrozole & Fulvestrant

Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.

48 / 348322 / 348Not reported / Not reported

Group identifiers: EG000: Anastrozole · EG001: Anastrozole & Fulvestrant

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
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Blood/Bone Marrow-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
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Febrile neutropenia
  3. 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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Hemoglobin
  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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Atrioventricular block - 2nd degree Mobitz Type II
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      348
    term
    Cardiac-ischemia/infarction
  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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    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
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      348
    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
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      348
    term
    Restrictive cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Dry eye syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      348
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      348
    term
    Ileus, GI (functional obstruction of bowel)

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
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      348
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      348
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      348
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      348
    term
    Dry mouth/salivary gland (xerostomia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      348
    term
    Heartburn/dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      348
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      348
    term
    Pain - Abdomen NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      348
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      348
    term
    Edema: limb
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      203
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      220
      num At Risk
      348
    term
    Fatigue (asthenia, lethargy, malaise)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      348
    term
    Fever in absence of neutropenia, ANC lt1.0x10e9/L
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      348
    term
    Injection site reaction/extravasation changes
Complete source fields
description
Eligible patients who had received the protocol treatments and who were evaluable for adverse event assessment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
event Groups
  1. description
    Patients receive oral anastrozole once daily on days 1-28
    id
    EG000
    other Num Affected
    309
    other Num At Risk
    337
    serious Num Affected
    21
    serious Num At Risk
    337
    title
    Anastrozole
  2. description
    Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1 , 14, and 28 during course 1 and then on day 28 of the subsequent courses.
    id
    EG001
    other Num Affected
    322
    other Num At Risk
    348
    serious Num Affected
    48
    serious Num At Risk
    348
    title
    Anastrozole & Fulvestrant
frequency Threshold
5
other 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
      64
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      348
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      89
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      110
      num At Risk
      348
    term
    Constipation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      348
    term
    Diarrhea
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      348
    term
    Dry mouth/salivary gland (xerostomia)
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      348
    term
    Heartburn/dyspepsia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      114
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      348
    term
    Nausea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      348
    term
    Pain - Abdomen NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      60
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      348
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      89
      num At Risk
      348
    term
    Edema: limb
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      203
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      220
      num At Risk
      348
    term
    Fatigue (asthenia, lethargy, malaise)
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      348
    term
    Fever in absence of neutropenia, ANC lt1.0x10e9/L
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      348
    term
    Injection site reaction/extravasation changes
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
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Blood/Bone Marrow-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
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Febrile neutropenia
  3. 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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Hemoglobin
  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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Atrioventricular block - 2nd degree Mobitz Type II
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      348
    term
    Cardiac-ischemia/infarction
  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
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    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
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      348
    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
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      348
    term
    Restrictive cardiomyopathy
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Dry eye syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      348
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      348
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      337
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      348
    term
    Ileus, GI (functional obstruction of bowel)
time Frame
Patients were assessed for adverse events after each cycle (1 cycle = 28 days) while on treatment.

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