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NCT01602380 · BASELINE

Baseline characteristics

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer. · Source last updated 2026-02-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      230
    2. group Id
      BG001
      value
      232
    3. group Id
      BG002
      value
      462
    units
    Participants
groups
  1. description
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    id
    BG000
    title
    Fulvestrant 500 mg
  2. description
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    id
    BG001
    title
    Anastrozole 1 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          spread
          9.86
          upper Limit
          87
          value
          63.8
        2. group Id
          BG001
          lower Limit
          36
          spread
          10.38
          upper Limit
          90
          value
          63.3
        3. group Id
          BG002
          lower Limit
          36
          spread
          10.12
          upper Limit
          90
          value
          63.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          462
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          70
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          174
        3. group Id
          BG002
          value
          349
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intention to treat (ITT) analysis set included all randomised patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      230
    2. group Id
      BG001
      value
      232
    3. group Id
      BG002
      value
      462
    units
    Participants
groups
  1. description
    Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
    id
    BG000
    title
    Fulvestrant 500 mg
  2. description
    Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 \[±3\], 28 \[±3\] and every 28 \[±3\] days thereafter).
    id
    BG001
    title
    Anastrozole 1 mg
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          38
          spread
          9.86
          upper Limit
          87
          value
          63.8
        2. group Id
          BG001
          lower Limit
          36
          spread
          10.38
          upper Limit
          90
          value
          63.3
        3. group Id
          BG002
          lower Limit
          36
          spread
          10.12
          upper Limit
          90
          value
          63.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          462
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          70
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          174
        3. group Id
          BG002
          value
          349
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          29
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The intention to treat (ITT) analysis set included all randomised patients.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice