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NCT00499616 · BASELINE

Baseline characteristics

Combination Chemotherapy and Surgery With or Without Isotretinoin in Treating Young Patients With Neuroblastoma · Source last updated 2021-07-06

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
      176
    2. group Id
      BG001
      value
      142
    3. group Id
      BG002
      value
      89
    4. group Id
      BG003
      value
      57
    5. group Id
      BG004
      value
      464
    units
    Participants
groups
  1. description
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    id
    BG000
    title
    Group 2 (Chemotherapy, Surgery)
  2. description
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    BG001
    title
    Group 3 (Chemotherapy, Surgery)
  3. description
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    BG002
    title
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
  4. description
    The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531. Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.
    id
    BG003
    title
    Non-intermediate Risk Enrolled on Intermediate Risk Trial
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          57
        5. group Id
          BG004
          value
          464
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.47
          value
          1.23
        2. group Id
          BG001
          spread
          .89
          value
          .74
        3. group Id
          BG002
          spread
          .36
          value
          .60
        4. group Id
          BG003
          spread
          1.83
          value
          1.51
        5. group Id
          BG004
          spread
          1.26
          value
          0.99
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          49
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          217
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          247
        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
          18
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          57
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          382
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          52
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          324
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          59
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          37
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          412
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          12
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      176
    2. group Id
      BG001
      value
      142
    3. group Id
      BG002
      value
      89
    4. group Id
      BG003
      value
      57
    5. group Id
      BG004
      value
      464
    units
    Participants
groups
  1. description
    2 courses of initial chemotherapy (6 wks) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Partial response (PR) to chemo go to observation. No PR: 2-6 additional courses of chemo (beginning course 3 - cyclophosphamide, etoposide, filgrastim, carboplatin, doxorubicin hydrochloride). No PR after additional chemotherapy proceed to retrieval chemo: cyclophosphamide and topotecan hydrochloride on days 1-5. Treatment with retrieval chemotherapy repeats every 21 days for up to 6 courses. Some patients may also undergo surgery.
    id
    BG000
    title
    Group 2 (Chemotherapy, Surgery)
  2. description
    4 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, filgrastim. Patients with a PR after chemo proceed to observation. No PR receive 2-4 additional courses of chemotherapy (beginning with course 5) - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. No PR after additional chemo proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    BG001
    title
    Group 3 (Chemotherapy, Surgery)
  3. description
    8 courses of initial chemo - carboplatin, cyclophosphamide, doxorubicin hydrochloride, etoposide, filgrastim. Patients \< 12 months of age with stg 3, 4, or 4S disease who achieve a very good PR (VGPR) to chemo (with the exception of resolution of skin or liver metastases in stage 4S patients) proceed to observation. Patients 12-18 months of age with stg 3 or 4 who achieve VGPR proceed to isotretinoin therapy. No VGPR proceed to retrieval chemo - cyclophosphamide and topotecan hydrochloride. Some patients may also undergo surgery.
    id
    BG002
    title
    Group 4 (Chemotherapy, Surgery, Antineoplastic Therapy)
  4. description
    The no treatment group assignment patients may have received some treatment on ANBL0531 but they were not evaluable on this study due to being non-intermediate risk and hence did not receive a treatment assignment on ANBL0531. Surgery: With the exception of patients with INSS 4S disease, patients undergo surgery to remove as much of the primary tumor and involved lymph nodes as can safely be accomplished.
    id
    BG003
    title
    Non-intermediate Risk Enrolled on Intermediate Risk Trial
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          142
        3. group Id
          BG002
          value
          89
        4. group Id
          BG003
          value
          57
        5. group Id
          BG004
          value
          464
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.47
          value
          1.23
        2. group Id
          BG001
          spread
          .89
          value
          .74
        3. group Id
          BG002
          spread
          .36
          value
          .60
        4. group Id
          BG003
          spread
          1.83
          value
          1.51
        5. group Id
          BG004
          spread
          1.26
          value
          0.99
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          49
        4. group Id
          BG003
          value
          26
        5. group Id
          BG004
          value
          217
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          247
        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
          18
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          57
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          150
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          49
        5. group Id
          BG004
          value
          382
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          25
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          52
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          40
        5. group Id
          BG004
          value
          324
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          59
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
      title
      New Zealand
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          37
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          131
        3. group Id
          BG002
          value
          78
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          412
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          12
      title
      Australia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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