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NCT00769704 · BASELINE

Baseline characteristics

Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma · Source last updated 2016-07-13

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
      141
    2. group Id
      BG001
      value
      296
    3. group Id
      BG002
      value
      437
    units
    Participants
groups
  1. description
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    id
    BG000
    title
    GM-CSF
  2. description
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    id
    BG001
    title
    Talimogene Laherparepvec
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.13
          value
          62.92
        2. group Id
          BG001
          spread
          13.68
          value
          63.07
        3. group Id
          BG002
          spread
          13.81
          value
          63.03
    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
          64
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          187
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          250
        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
          138
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          428
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          307
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          114
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
      title
      Missing
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          34
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          97
      title
      Stage IIIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          119
      title
      Stage IV M1a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          90
      title
      Stage IV M1b
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          96
      title
      Stage IV M1c
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Stage IIIB: Ulcerated lesion and 1 lymph node or 2-3 nodes with micrometastasis, or any-depth lesion with no ulceration, and 1 lymph node or 2-3 nodes with macrometastasis; Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs, normal LDH; M1c: Spread to all other visceral organs, normal LDH or any distant disease with elevated LDH.
    param Type
    NUMBER
    title
    Tumor, Node, Metastasis (TNM) Disease Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          203
      title
      First Line
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          234
      title
      Second Line or Greater
    param Type
    NUMBER
    title
    Line of Therapy
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      141
    2. group Id
      BG001
      value
      296
    3. group Id
      BG002
      value
      437
    units
    Participants
groups
  1. description
    GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 days in 28-day cycles for 24 weeks. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, or lack of response by 12 months, for a maximum of 18 months.
    id
    BG000
    title
    GM-CSF
  2. description
    Participants received talimogene laherparepvec on Days 1 and 15 of each 28-day cycle for 24 weeks. The initial dose was at a concentration of 10⁶ PFU/mL, injected into 1 or more skin, subcutaneous or nodal tumors. Subsequent doses began at least 3 weeks after the first dose and consisted of talimogene laherparepvec at a concentration of 10⁸ PFU/mL. Participants could continue treatment until clinically relevant disease progression, intolerability, withdrawal of consent, complete remission, lack of response by 12 months, or disappearance of all injectable lesions, for a maximum of 18 months.
    id
    BG001
    title
    Talimogene Laherparepvec
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.13
          value
          62.92
        2. group Id
          BG001
          spread
          13.68
          value
          63.07
        3. group Id
          BG002
          spread
          13.81
          value
          63.03
    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
          64
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          187
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          250
        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
          138
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          428
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          307
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          114
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          16
      title
      Missing
    description
    Scale used to assess how a patient's disease is progressing, how the disease affects the daily living abilities of the patient: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self care, confined to a bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          34
      title
      Stage IIIB
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          66
        3. group Id
          BG002
          value
          97
      title
      Stage IIIC
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          119
      title
      Stage IV M1a
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          90
      title
      Stage IV M1b
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          96
      title
      Stage IV M1c
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Missing
    description
    Stage IIIB: Ulcerated lesion and 1 lymph node or 2-3 nodes with micrometastasis, or any-depth lesion with no ulceration, and 1 lymph node or 2-3 nodes with macrometastasis; Stage IIIC: Ulcerated lesion and 1 lymph node with macrometastasis; 2-3 nodes with macrometastasis or ≥4 metastatic lymph nodes, matted lymph nodes, or in-transit met(s)/satellite(s); Stage IV: M1a: Spread to skin, subcutaneous tissue, or lymph nodes; normal lactate dehydrogenase (LDH) level; M1b: Spread to lungs, normal LDH; M1c: Spread to all other visceral organs, normal LDH or any distant disease with elevated LDH.
    param Type
    NUMBER
    title
    Tumor, Node, Metastasis (TNM) Disease Stage
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          203
      title
      First Line
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          158
        3. group Id
          BG002
          value
          234
      title
      Second Line or Greater
    param Type
    NUMBER
    title
    Line of Therapy
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice