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NCT02445248 · BASELINE

Baseline characteristics

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients · Source last updated 2024-04-18

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
      99
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      115
    units
    Participants
groups
  1. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
    id
    BG000
    title
    Tisagenlecleucel - Main Cohort
  2. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    BG001
    title
    Tisagenlecleucel Cohort A
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.09
          value
          54.3
        2. group Id
          BG001
          spread
          12.98
          value
          51.1
        3. group Id
          BG002
          spread
          13.07
          value
          53.8
    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
          36
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          71
        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
          83
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          98
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          65
      title
      ECOG status of 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          50
      title
      ECOG status of 1
    description
    The Eastern Cooperative Oncology Group (ECOG) Performance status is a numbering scale used in Oncology w to define the population of patients to study in the trial and guide physicians who enroll patients into those studies. The lower the number the better the performance status of the patient, where 0: Fully active, able to carry on all pre-disease performance without restriction. ECOG Performance status of 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
    param Type
    NUMBER
    title
    ECOG performance status
    unit Of Measure
    Participants
population Description
Full analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      99
    2. group Id
      BG001
      value
      16
    3. group Id
      BG002
      value
      115
    units
    Participants
groups
  1. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Novartis manufacturing facility in Morris Plains, US.
    id
    BG000
    title
    Tisagenlecleucel - Main Cohort
  2. description
    Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received tisagenlecleucel manufactured at the Fraunhofer Institut für Zelltherapie, Leipzig, Germany.
    id
    BG001
    title
    Tisagenlecleucel Cohort A
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.09
          value
          54.3
        2. group Id
          BG001
          spread
          12.98
          value
          51.1
        3. group Id
          BG002
          spread
          13.07
          value
          53.8
    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
          36
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          44
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          71
        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
          83
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          98
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
      title
      Black
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          65
      title
      ECOG status of 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          50
      title
      ECOG status of 1
    description
    The Eastern Cooperative Oncology Group (ECOG) Performance status is a numbering scale used in Oncology w to define the population of patients to study in the trial and guide physicians who enroll patients into those studies. The lower the number the better the performance status of the patient, where 0: Fully active, able to carry on all pre-disease performance without restriction. ECOG Performance status of 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
    param Type
    NUMBER
    title
    ECOG performance status
    unit Of Measure
    Participants
population Description
Full analysis Set (FAS): Comprised all patients who received infusion of tisagenlecleucel.

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