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NCT03735680 · BASELINE

Baseline characteristics

A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer · Source last updated 2023-07-07

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      11
    7. group Id
      BG006
      value
      30
    units
    Participants
groups
  1. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    BG000
    title
    Part 1, Cohort A
  2. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    BG001
    title
    Part 1, Cohort B
  3. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 2 mg/kg and underwent surgery and fluorescence imaging at 6 ±3 hours post dose.
    id
    BG002
    title
    Part 1, Cohort E
  4. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg and underwent surgery and fluorescence imaging at a time to be determined post dose.
    id
    BG003
    title
    Part 2, Group 2
  5. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 16-80 hours post dose.
    id
    BG004
    title
    Part 2, Group 3
  6. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 24 ±8 hours post dose.
    id
    BG005
    title
    Part 3
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.19
          value
          56.0
        2. group Id
          BG001
          spread
          3.79
          value
          63.7
        3. group Id
          BG002
          spread
          15.31
          value
          59.3
        4. group Id
          BG003
          spread
          5.07
          value
          65.5
        5. group Id
          BG004
          spread
          4.71
          value
          59.8
        6. group Id
          BG005
          spread
          10.26
          value
          59.8
        7. group Id
          BG006
          spread
          8.46
          value
          60.5
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          22
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          25
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          22
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          30
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Patients receiving pegsitacianine (ONM-100)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      11
    7. group Id
      BG006
      value
      30
    units
    Participants
groups
  1. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    BG000
    title
    Part 1, Cohort A
  2. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose.
    id
    BG001
    title
    Part 1, Cohort B
  3. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 2 mg/kg and underwent surgery and fluorescence imaging at 6 ±3 hours post dose.
    id
    BG002
    title
    Part 1, Cohort E
  4. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg and underwent surgery and fluorescence imaging at a time to be determined post dose.
    id
    BG003
    title
    Part 2, Group 2
  5. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 16-80 hours post dose.
    id
    BG004
    title
    Part 2, Group 3
  6. description
    Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 24 ±8 hours post dose.
    id
    BG005
    title
    Part 3
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.19
          value
          56.0
        2. group Id
          BG001
          spread
          3.79
          value
          63.7
        3. group Id
          BG002
          spread
          15.31
          value
          59.3
        4. group Id
          BG003
          spread
          5.07
          value
          65.5
        5. group Id
          BG004
          spread
          4.71
          value
          59.8
        6. group Id
          BG005
          spread
          10.26
          value
          59.8
        7. group Id
          BG006
          spread
          8.46
          value
          60.5
    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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          22
        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
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          25
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          22
        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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          30
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          30
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Patients receiving pegsitacianine (ONM-100)
    unit Of Measure
    Participants

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