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NCT00094653 · BASELINE

Baseline characteristics

MDX-010 Antibody, MDX-1379 Melanoma Vaccine, or MDX-010/MDX-1379 Combination Treatment for Patients With Unresectable or Metastatic Melanoma · Source last updated 2011-07-11

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
      403
    2. group Id
      BG001
      value
      137
    3. group Id
      BG002
      value
      136
    4. group Id
      BG003
      value
      676
    units
    Participants
groups
  1. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG000
    title
    Ipilimumab Plus gp100
  2. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG001
    title
    Ipilimumab Monotherapy
  3. description
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG002
    title
    gp100
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          84
          value
          55.6
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          88
          value
          56.8
        3. group Id
          BG002
          lower Limit
          23
          upper Limit
          90
          value
          57.4
        4. group Id
          BG003
          lower Limit
          19
          upper Limit
          90
          value
          56.2
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          291
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          480
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          196
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          275
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          247
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          73
        4. group Id
          BG003
          value
          401
        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
          380
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          129
        4. group Id
          BG003
          value
          638
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          30
      title
      Hispanic
    4. 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
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.2
          upper Limit
          38.9
          value
          5.09
        2. group Id
          BG001
          lower Limit
          -0.0
          upper Limit
          35.9
          value
          4.34
        3. group Id
          BG002
          lower Limit
          0.3
          upper Limit
          31.2
          value
          5.65
        4. group Id
          BG003
          lower Limit
          -0.0
          upper Limit
          38.9
          value
          5.05
    description
    Duration of melanoma is the number of years from date of initial diagnosis to the date of randomization. The randomization of 1 participant in the ipilumumab monotherapy cohort was prior to the initial diagnostic date. Data for 2 participants in the ipilimumab + gp100 cohort were missing.
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Duration of Melanoma
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      M0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          62
      title
      M1a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          121
      title
      M1b
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          285
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          483
      title
      M1c
    description
    The "M" in the TNM (tumor, node, metastasis) system refers to distant metastases-whether, and how far, the cancer has spread outside the original site. M0: There is no evidence that the cancer has spread beyond the original site. M1: The cancer has spread beyond the original site. M1a: The cancer has spread to other areas of skin, underneath the epidermis to the dermis (subcutaneous), or to lymph node(s). M1b: The cancer has spread to the lung(s) only. M1c: The cancer has spread to other organs and/or locations in the body with or without elevated LDH.
    param Type
    NUMBER
    title
    Melanoma Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          314
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          522
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          154
      title
      Yes
    param Type
    NUMBER
    title
    Prior Interleukin-2 Therapy
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          254
      title
      >upper limit of normal (ULN)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          81
        4. group Id
          BG003
          value
          417
      title
      <=ULN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
      title
      unknown
    description
    Upper limit of normal (ULN) was 250 U/L for most assessments (some variation caused by tests performed at local laboratories).
    param Type
    NUMBER
    title
    Lactate Dehydrogenase
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      403
    2. group Id
      BG001
      value
      137
    3. group Id
      BG002
      value
      136
    4. group Id
      BG003
      value
      676
    units
    Participants
groups
  1. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG000
    title
    Ipilimumab Plus gp100
  2. description
    Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG001
    title
    Ipilimumab Monotherapy
  3. description
    Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288\[288V\]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217\[210M\]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
    id
    BG002
    title
    gp100
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          24
          upper Limit
          84
          value
          55.6
        2. group Id
          BG001
          lower Limit
          19
          upper Limit
          88
          value
          56.8
        3. group Id
          BG002
          lower Limit
          23
          upper Limit
          90
          value
          57.4
        4. group Id
          BG003
          lower Limit
          19
          upper Limit
          90
          value
          56.2
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          291
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          94
        4. group Id
          BG003
          value
          480
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          112
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          196
      title
      >=65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          63
        4. group Id
          BG003
          value
          275
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          247
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          73
        4. group Id
          BG003
          value
          401
        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
          380
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          129
        4. group Id
          BG003
          value
          638
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          5
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          30
      title
      Hispanic
    4. 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
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.2
          upper Limit
          38.9
          value
          5.09
        2. group Id
          BG001
          lower Limit
          -0.0
          upper Limit
          35.9
          value
          4.34
        3. group Id
          BG002
          lower Limit
          0.3
          upper Limit
          31.2
          value
          5.65
        4. group Id
          BG003
          lower Limit
          -0.0
          upper Limit
          38.9
          value
          5.05
    description
    Duration of melanoma is the number of years from date of initial diagnosis to the date of randomization. The randomization of 1 participant in the ipilumumab monotherapy cohort was prior to the initial diagnostic date. Data for 2 participants in the ipilimumab + gp100 cohort were missing.
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Duration of Melanoma
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      M0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          62
      title
      M1a
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          121
      title
      M1b
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          285
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          98
        4. group Id
          BG003
          value
          483
      title
      M1c
    description
    The "M" in the TNM (tumor, node, metastasis) system refers to distant metastases-whether, and how far, the cancer has spread outside the original site. M0: There is no evidence that the cancer has spread beyond the original site. M1: The cancer has spread beyond the original site. M1a: The cancer has spread to other areas of skin, underneath the epidermis to the dermis (subcutaneous), or to lymph node(s). M1b: The cancer has spread to the lung(s) only. M1c: The cancer has spread to other organs and/or locations in the body with or without elevated LDH.
    param Type
    NUMBER
    title
    Melanoma Stage
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          314
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          522
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          154
      title
      Yes
    param Type
    NUMBER
    title
    Prior Interleukin-2 Therapy
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          254
      title
      >upper limit of normal (ULN)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          84
        3. group Id
          BG002
          value
          81
        4. group Id
          BG003
          value
          417
      title
      <=ULN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
      title
      unknown
    description
    Upper limit of normal (ULN) was 250 U/L for most assessments (some variation caused by tests performed at local laboratories).
    param Type
    NUMBER
    title
    Lactate Dehydrogenase
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice