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NCT01077154 · BASELINE

Baseline characteristics

Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE) · Source last updated 2021-09-28

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
      2253
    2. group Id
      BG001
      value
      2256
    3. group Id
      BG002
      value
      4509
    units
    Participants
groups
  1. description
    Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
    id
    BG000
    title
    Placebo
  2. description
    Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          51.6
        2. group Id
          BG001
          spread
          10.7
          value
          51.4
        3. group Id
          BG002
          spread
          10.7
          value
          51.5
    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
          1960
        2. group Id
          BG001
          value
          1959
        3. group Id
          BG002
          value
          3919
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          519
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          69
        title
        75 - 84 years
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2253
        2. group Id
          BG001
          value
          2256
        3. group Id
          BG002
          value
          4509
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1692
        2. group Id
          BG001
          value
          1676
        3. group Id
          BG002
          value
          3368
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          435
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          134
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          269
        title
        Japanese
      4. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          247
        title
        Hispanic/Latino
      5. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          144
        title
        Black
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Native Hawaiian or Other Pacific Islander
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      8. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          38
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1165
        2. group Id
          BG001
          value
          1195
        3. group Id
          BG002
          value
          2360
        title
        Premenopausal
      2. measurements
        1. group Id
          BG000
          value
          1088
        2. group Id
          BG001
          value
          1061
        3. group Id
          BG002
          value
          2149
        title
        Postmenopausal
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1913
        2. group Id
          BG001
          value
          1922
        3. group Id
          BG002
          value
          3835
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          340
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          669
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        2 (Ambulatory, unable to work)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Missing
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          550
        2. group Id
          BG001
          value
          552
        3. group Id
          BG002
          value
          1102
        title
        Neo-adjuvant therapy / any lymph node status
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          133
        title
        Adjuvant therapy / lymph node negative
      3. measurements
        1. group Id
          BG000
          value
          1635
        2. group Id
          BG001
          value
          1639
        3. group Id
          BG002
          value
          3274
        title
        Adjuvant therapy / lymph node positive
    description
    Breast cancer therapy / lymph node (LN) status: 1. neo-adjuvant therapy / any LN status; 2. adjuvant therapy / LN negative (based on axillary LN dissection, or based on sentinel node \[SN\] status); 3. adjuvant therapy / LN positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Breast Cancer Therapy / Lymph Node Status (Strata per Randomization)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1740
        2. group Id
          BG001
          value
          1747
        3. group Id
          BG002
          value
          3487
        title
        ER and/or PR positive
      2. measurements
        1. group Id
          BG000
          value
          513
        2. group Id
          BG001
          value
          509
        3. group Id
          BG002
          value
          1022
        title
        ER and PR negative
    description
    Hormone receptor (estrogen receptor \[ER\] / progesterone receptor \[PR\]) status 1. ER and/or PR positive 2. ER and PR negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status (Strata per Randomization)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          490
        2. group Id
          BG001
          value
          492
        3. group Id
          BG002
          value
          982
        title
        HER-2 positive
      2. measurements
        1. group Id
          BG000
          value
          1763
        2. group Id
          BG001
          value
          1764
        3. group Id
          BG002
          value
          3527
        title
        HER-2 negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Epidermal Growth Factor Receptor 2 (HER-2) Status (Strata per Randomization)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1026
        2. group Id
          BG001
          value
          1029
        3. group Id
          BG002
          value
          2055
        title
        < 50 years
      2. measurements
        1. group Id
          BG000
          value
          1227
        2. group Id
          BG001
          value
          1227
        3. group Id
          BG002
          value
          2454
        title
        ≥ 50 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age (Strata per Randomization)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          262
        title
        Japan
      2. measurements
        1. group Id
          BG000
          value
          2122
        2. group Id
          BG001
          value
          2125
        3. group Id
          BG002
          value
          4247
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region (Strata per Randomization)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          286
        3. group Id
          BG002
          value
          574
        title
        HR positive and HER-2 positive
      2. measurements
        1. group Id
          BG000
          value
          1460
        2. group Id
          BG001
          value
          1458
        3. group Id
          BG002
          value
          2918
        title
        HR positive and HER-2 negative
      3. measurements
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          331
        title
        HR negative and HER-2 positive
      4. measurements
        1. group Id
          BG000
          value
          341
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          684
        title
        HR negative and HER-2 negative
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Missing
    description
    Hormone receptor (HR; estrogen receptor \[ER\] / progesterone receptor \[PR\]); HR positive = ER and/or PR positive; HR negative = ER and PR negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Molecular Subtypes of Breast Cancer
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2253
    2. group Id
      BG001
      value
      2256
    3. group Id
      BG002
      value
      4509
    units
    Participants
groups
  1. description
    Participants were randomized to receive placebo subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by placebo subcutaneous injections once every 3 months for 4.5 years.
    id
    BG000
    title
    Placebo
  2. description
    Participants were randomized to receive denosumab 120 mg subcutaneous injections once every 3 or 4 weeks for approximately 6 months followed by denosumab 120 mg subcutaneous injections once every 3 months for 4.5 years.
    id
    BG001
    title
    Denosumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.6
          value
          51.6
        2. group Id
          BG001
          spread
          10.7
          value
          51.4
        3. group Id
          BG002
          spread
          10.7
          value
          51.5
    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
          1960
        2. group Id
          BG001
          value
          1959
        3. group Id
          BG002
          value
          3919
        title
        18 - 64 years
      2. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          260
        3. group Id
          BG002
          value
          519
        title
        65 - 74 years
      3. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          69
        title
        75 - 84 years
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2253
        2. group Id
          BG001
          value
          2256
        3. group Id
          BG002
          value
          4509
        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
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1692
        2. group Id
          BG001
          value
          1676
        3. group Id
          BG002
          value
          3368
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          222
        2. group Id
          BG001
          value
          213
        3. group Id
          BG002
          value
          435
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          134
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          269
        title
        Japanese
      4. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          247
        title
        Hispanic/Latino
      5. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          144
        title
        Black
      6. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        Native Hawaiian or Other Pacific Islander
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      8. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          38
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1165
        2. group Id
          BG001
          value
          1195
        3. group Id
          BG002
          value
          2360
        title
        Premenopausal
      2. measurements
        1. group Id
          BG000
          value
          1088
        2. group Id
          BG001
          value
          1061
        3. group Id
          BG002
          value
          2149
        title
        Postmenopausal
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Menopausal Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1913
        2. group Id
          BG001
          value
          1922
        3. group Id
          BG002
          value
          3835
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          340
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          669
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        2 (Ambulatory, unable to work)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Missing
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          550
        2. group Id
          BG001
          value
          552
        3. group Id
          BG002
          value
          1102
        title
        Neo-adjuvant therapy / any lymph node status
      2. measurements
        1. group Id
          BG000
          value
          68
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          133
        title
        Adjuvant therapy / lymph node negative
      3. measurements
        1. group Id
          BG000
          value
          1635
        2. group Id
          BG001
          value
          1639
        3. group Id
          BG002
          value
          3274
        title
        Adjuvant therapy / lymph node positive
    description
    Breast cancer therapy / lymph node (LN) status: 1. neo-adjuvant therapy / any LN status; 2. adjuvant therapy / LN negative (based on axillary LN dissection, or based on sentinel node \[SN\] status); 3. adjuvant therapy / LN positive
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Breast Cancer Therapy / Lymph Node Status (Strata per Randomization)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1740
        2. group Id
          BG001
          value
          1747
        3. group Id
          BG002
          value
          3487
        title
        ER and/or PR positive
      2. measurements
        1. group Id
          BG000
          value
          513
        2. group Id
          BG001
          value
          509
        3. group Id
          BG002
          value
          1022
        title
        ER and PR negative
    description
    Hormone receptor (estrogen receptor \[ER\] / progesterone receptor \[PR\]) status 1. ER and/or PR positive 2. ER and PR negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Hormone Receptor Status (Strata per Randomization)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          490
        2. group Id
          BG001
          value
          492
        3. group Id
          BG002
          value
          982
        title
        HER-2 positive
      2. measurements
        1. group Id
          BG000
          value
          1763
        2. group Id
          BG001
          value
          1764
        3. group Id
          BG002
          value
          3527
        title
        HER-2 negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Human Epidermal Growth Factor Receptor 2 (HER-2) Status (Strata per Randomization)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1026
        2. group Id
          BG001
          value
          1029
        3. group Id
          BG002
          value
          2055
        title
        < 50 years
      2. measurements
        1. group Id
          BG000
          value
          1227
        2. group Id
          BG001
          value
          1227
        3. group Id
          BG002
          value
          2454
        title
        ≥ 50 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age (Strata per Randomization)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          262
        title
        Japan
      2. measurements
        1. group Id
          BG000
          value
          2122
        2. group Id
          BG001
          value
          2125
        3. group Id
          BG002
          value
          4247
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region (Strata per Randomization)
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          288
        2. group Id
          BG001
          value
          286
        3. group Id
          BG002
          value
          574
        title
        HR positive and HER-2 positive
      2. measurements
        1. group Id
          BG000
          value
          1460
        2. group Id
          BG001
          value
          1458
        3. group Id
          BG002
          value
          2918
        title
        HR positive and HER-2 negative
      3. measurements
        1. group Id
          BG000
          value
          163
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          331
        title
        HR negative and HER-2 positive
      4. measurements
        1. group Id
          BG000
          value
          341
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          684
        title
        HR negative and HER-2 negative
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Missing
    description
    Hormone receptor (HR; estrogen receptor \[ER\] / progesterone receptor \[PR\]); HR positive = ER and/or PR positive; HR negative = ER and PR negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Molecular Subtypes of Breast Cancer
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice