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NCT04083235 · BASELINE

Baseline characteristics

A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment · Source last updated 2026-04-20

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
      383
    2. group Id
      BG001
      value
      387
    3. group Id
      BG002
      value
      770
    units
    Participants
groups
  1. description
    Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    id
    BG000
    title
    NALIRIFOX
  2. description
    Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    id
    BG001
    title
    Nab-paclitaxel+Gemcitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.71
          value
          62.8
        2. group Id
          BG001
          spread
          8.34
          value
          64.0
        3. group Id
          BG002
          spread
          9.06
          value
          63.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          336
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          434
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          79
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          633
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          58
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          324
        3. group Id
          BG002
          value
          639
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          55
      title
      Not Reported
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      American Indian or Alaska Native
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population consisted of all randomized participants to whom study treatment was assigned by randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      383
    2. group Id
      BG001
      value
      387
    3. group Id
      BG002
      value
      770
    units
    Participants
groups
  1. description
    Participants were treated with irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2, followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    id
    BG000
    title
    NALIRIFOX
  2. description
    Participants were treated with nab-paclitaxel 125 mg/m\^2 followed by gemcitabine 1000 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
    id
    BG001
    title
    Nab-paclitaxel+Gemcitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.71
          value
          62.8
        2. group Id
          BG001
          spread
          8.34
          value
          64.0
        3. group Id
          BG002
          spread
          9.06
          value
          63.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          336
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          204
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          434
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          79
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          305
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          633
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          58
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          315
        2. group Id
          BG001
          value
          324
        3. group Id
          BG002
          value
          639
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          55
      title
      Not Reported
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
      title
      Black or African American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      Other
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
      title
      Multiple
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      title
      American Indian or Alaska Native
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      Native Hawaiian or Other Pacific Islander
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Intent-to-Treat (ITT) population consisted of all randomized participants to whom study treatment was assigned by randomization.

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Preserved source evidence · Not medical advice