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NCT01353222 · BASELINE

Baseline characteristics

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma · Source last updated 2017-05-25

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
      70
    2. group Id
      BG001
      value
      72
    3. group Id
      BG002
      value
      142
    units
    Participants
groups
  1. description
    DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
    id
    BG000
    title
    DN24-02
  2. description
    Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          74
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.81
          value
          65.6
        2. group Id
          BG001
          spread
          10.09
          value
          66.4
        3. group Id
          BG002
          spread
          10.42
          value
          66.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    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
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          37
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          105
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          135
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.3080
          value
          80.770
        2. group Id
          BG001
          spread
          17.9330
          value
          82.115
        3. group Id
          BG002
          spread
          18.0679
          value
          81.448
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          141
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Baseline weight for one subject in standard of care group is missing.
    title
    Body weight
    unit Of Measure
    kilograms
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          80
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 0=Fully Active; No restrictions
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 1= Restricted Strenuous Activity
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 2=Ambulatory, capable of self-care; no work
    description
    ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline ECOG data is missing for one subject in each group.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Intent to treat population
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      70
    2. group Id
      BG001
      value
      72
    3. group Id
      BG002
      value
      142
    units
    Participants
groups
  1. description
    DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
    id
    BG000
    title
    DN24-02
  2. description
    Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          68
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          74
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.81
          value
          65.6
        2. group Id
          BG001
          spread
          10.09
          value
          66.4
        3. group Id
          BG002
          spread
          10.42
          value
          66.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    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
          18
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          37
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          105
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          70
        3. group Id
          BG002
          value
          135
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          142
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          18.3080
          value
          80.770
        2. group Id
          BG001
          spread
          17.9330
          value
          82.115
        3. group Id
          BG002
          spread
          18.0679
          value
          81.448
      denoms
      1. counts
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          141
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Baseline weight for one subject in standard of care group is missing.
    title
    Body weight
    unit Of Measure
    kilograms
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          80
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 0=Fully Active; No restrictions
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          55
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 1= Restricted Strenuous Activity
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          140
        units
        Participants
      title
      ECOG 2=Ambulatory, capable of self-care; no work
    description
    ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline ECOG data is missing for one subject in each group.
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Intent to treat population

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Preserved source evidence · Not medical advice