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NCT04241315 · BASELINE

Baseline characteristics

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting · Source last updated 2023-03-23

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
      100
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      111
    units
    Participants
groups
  1. description
    All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system
    id
    BG000
    title
    Near-Infrared Imaging Group
  2. description
    All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
    id
    BG001
    title
    No Imaging Group
  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
          36
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          70
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.68
          value
          66
        2. group Id
          BG001
          spread
          9.88
          value
          64
        3. group Id
          BG002
          spread
          9.67
          value
          65.9
    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
          61
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          110
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          96
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          111
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      100
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      111
    units
    Participants
groups
  1. description
    All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL Near infrared camera imaging system: Near infrared camera imaging system
    id
    BG000
    title
    Near-Infrared Imaging Group
  2. description
    All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging. OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
    id
    BG001
    title
    No Imaging Group
  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
          36
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          41
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          70
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.68
          value
          66
        2. group Id
          BG001
          spread
          9.88
          value
          64
        3. group Id
          BG002
          spread
          9.67
          value
          65.9
    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
          61
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          110
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        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
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          96
        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
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          111
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice