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NCT02360579 · BASELINE

Baseline characteristics

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma · Source last updated 2026-03-25

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
      23
    2. group Id
      BG001
      value
      67
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      89
    5. group Id
      BG004
      value
      191
    units
    Participants
groups
  1. description
    Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
    id
    BG000
    title
    Cohort 1
  2. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
    id
    BG001
    title
    Cohort 2
  3. description
    Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed)
    id
    BG002
    title
    Cohort 3
  4. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
    id
    BG003
    title
    Cohort 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          140
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          39
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG002
          value
          11
        2. group Id
          BG004
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG002
          value
          1
        2. group Id
          BG004
          value
          1
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          72
          value
          52
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          79
          value
          55
        3. group Id
          BG003
          lower Limit
          25
          upper Limit
          74
          value
          58
        4. group Id
          BG004
          lower Limit
          20
          upper Limit
          79
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG002
          lower Limit
          29
          upper Limit
          66
          value
          52
        2. group Id
          BG004
          lower Limit
          29
          upper Limit
          66
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Age, Continuous
    unit Of Measure
    Years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          95
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
        5. group Id
          BG004
          value
          161
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. 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
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Asian
      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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
        5. group Id
          BG004
          value
          172
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. 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
        American Indian or Alaska Native
      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
        Asian
      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
        Native Hawaiian or Other Pacific Islander
      4. 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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          134
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      United Kingdom
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        France
      3. 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
        Germany
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        United Kingdom
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
    description
    Region of enrollment for retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is the region of enrollment for retreatment
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set is defined as patients who received the lifileucel infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      23
    2. group Id
      BG001
      value
      67
    3. group Id
      BG002
      value
      12
    4. group Id
      BG003
      value
      89
    5. group Id
      BG004
      value
      191
    units
    Participants
groups
  1. description
    Non-cryopreserved LN-144 (Gen 1 infusion product) (Closed)
    id
    BG000
    title
    Cohort 1
  2. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
    id
    BG001
    title
    Cohort 2
  3. description
    Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b) (Closed)
    id
    BG002
    title
    Cohort 3
  4. description
    Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed)
    id
    BG003
    title
    Cohort 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. 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
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          140
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          39
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG002
          value
          11
        2. group Id
          BG004
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG002
          value
          1
        2. group Id
          BG004
          value
          1
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          37
          upper Limit
          72
          value
          52
        2. group Id
          BG001
          lower Limit
          20
          upper Limit
          79
          value
          55
        3. group Id
          BG003
          lower Limit
          25
          upper Limit
          74
          value
          58
        4. group Id
          BG004
          lower Limit
          20
          upper Limit
          79
          value
          56
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG002
          lower Limit
          29
          upper Limit
          66
          value
          52
        2. group Id
          BG004
          lower Limit
          29
          upper Limit
          66
          value
          52
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Age, Continuous
    unit Of Measure
    Years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          44
        5. group Id
          BG004
          value
          84
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          95
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          10
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
        5. group Id
          BG004
          value
          161
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          8
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          10
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. 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
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        title
        Asian
      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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          85
        5. group Id
          BG004
          value
          172
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Initial Treatment
    2. categories
      1. 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
        American Indian or Alaska Native
      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
        Asian
      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
        Native Hawaiian or Other Pacific Islander
      4. 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
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          9
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
      title
      Retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          55
        5. group Id
          BG004
          value
          134
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Germany
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Hungary
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Spain
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      Switzerland
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
      denoms
      1. counts
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          67
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          89
        5. group Id
          BG004
          value
          179
        units
        Participants
      title
      United Kingdom
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data prior to initial TIL treatment are presented in the retreatment period for Cohort 3
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        United States
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        France
      3. 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
        Germany
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        United Kingdom
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          12
        units
        Participants
    description
    Region of enrollment for retreatment
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    This is the region of enrollment for retreatment
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set is defined as patients who received the lifileucel infusion. Cohort 3 patients had progressed following initial treatment in Cohorts 1, 2, 4 and then were retreated with a second TIL regimen. Data are captured in the retreatment period for Cohort 3

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