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NCT00844649 · BASELINE

Baseline characteristics

Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas · Source last updated 2019-11-25

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
      431
    2. group Id
      BG001
      value
      430
    3. group Id
      BG002
      value
      861
    units
    Participants
groups
  1. description
    ABI-007 125 mg/m\^2 administered in combination with gemcitabine 1000 mg/m\^2 weekly for 3 weeks followed by one week of rest. Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m\^2 administered in combination with Gemcitabine 1000 mg/m\^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest
    id
    BG000
    title
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
  2. description
    Gemcitabine, 1000 mg/m\^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
    id
    BG001
    title
    Gemcitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.70
          value
          61.4
        2. group Id
          BG001
          spread
          9.27
          value
          63.0
        3. group Id
          BG002
          spread
          10.04
          value
          62.2
    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
          186
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          359
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          502
        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
          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
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          378
        2. group Id
          BG001
          value
          375
        3. group Id
          BG002
          value
          753
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          138
      title
      100% = normal, no complaints, no signs of disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          378
      title
      90% = normal activity, few symptoms of disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          277
      title
      80% = normal activity, some symptoms of disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
      title
      70% = caring for self, unable to work
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      60% = needs help, can manage most tasks
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      50% = needs help often and medical care
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      40% = disabled; requires special care & assistance
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      30% = severely disabled; death is imminent
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      20% = hospitalized; requires supportive treatment
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      10% = Moribund, fatal processes progressing fast
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      0% = Dead
    description
    The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.
    param Type
    NUMBER
    title
    Karnofsky Performance Status (KPS)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          371
      title
      Head
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          268
      title
      Body
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          215
      title
      Tail
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Unknown = not specified
    description
    Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.
    param Type
    NUMBER
    title
    Pancreatic Primary Tumor Location
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          57
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          80
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          276
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          538
      title
      >5
    description
    Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.
    param Type
    NUMBER
    title
    Number of Baseline Lesions (Target + Non-Target)
    unit Of Measure
    participants
population Description
For the Karnofsky Performance Status (KPS) baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      431
    2. group Id
      BG001
      value
      430
    3. group Id
      BG002
      value
      861
    units
    Participants
groups
  1. description
    ABI-007 125 mg/m\^2 administered in combination with gemcitabine 1000 mg/m\^2 weekly for 3 weeks followed by one week of rest. Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m\^2 administered in combination with Gemcitabine 1000 mg/m\^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest
    id
    BG000
    title
    Albumin-bound Paclitaxel (ABI-007)/Gemcitabine
  2. description
    Gemcitabine, 1000 mg/m\^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward). Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
    id
    BG001
    title
    Gemcitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.70
          value
          61.4
        2. group Id
          BG001
          spread
          9.27
          value
          63.0
        3. group Id
          BG002
          spread
          10.04
          value
          62.2
    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
          186
        2. group Id
          BG001
          value
          173
        3. group Id
          BG002
          value
          359
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          245
        2. group Id
          BG001
          value
          257
        3. group Id
          BG002
          value
          502
        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
          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
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          32
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          378
        2. group Id
          BG001
          value
          375
        3. group Id
          BG002
          value
          753
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          51
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          69
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          138
      title
      100% = normal, no complaints, no signs of disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          179
        2. group Id
          BG001
          value
          199
        3. group Id
          BG002
          value
          378
      title
      90% = normal activity, few symptoms of disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          149
        2. group Id
          BG001
          value
          128
        3. group Id
          BG002
          value
          277
      title
      80% = normal activity, some symptoms of disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
      title
      70% = caring for self, unable to work
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
      title
      60% = needs help, can manage most tasks
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      50% = needs help often and medical care
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      40% = disabled; requires special care & assistance
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      30% = severely disabled; death is imminent
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      20% = hospitalized; requires supportive treatment
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      10% = Moribund, fatal processes progressing fast
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      0% = Dead
    description
    The Karnofsky Performance Status Scale (KPS) was designed to measure the level of participant activity and medical care requirements. A general measure of participant independence and has been widely used as a general assessment of participants with cancer. The Karnofsky score runs from 100 to 0, where 100 is "perfect" health and 0 is death. The primary purpose of its development was to allow physicians to evaluate a participant's ability to survive chemotherapy for cancer. Two participants from the Albumin bound paclitaxel arm and one from the Gemcitabine arm did not have KPS performed.
    param Type
    NUMBER
    title
    Karnofsky Performance Status (KPS)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          180
        3. group Id
          BG002
          value
          371
      title
      Head
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          136
        3. group Id
          BG002
          value
          268
      title
      Body
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          215
      title
      Tail
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Unknown = not specified
    description
    Main location or area of the pancreas where the disease is detected at diagnosis. Unknown location refers to disease area not being specified.
    param Type
    NUMBER
    title
    Pancreatic Primary Tumor Location
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      1
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          57
      title
      2
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
      title
      3
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          80
      title
      4
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          16
      title
      5
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          276
        2. group Id
          BG001
          value
          262
        3. group Id
          BG002
          value
          538
      title
      >5
    description
    Target lesions are those measurable at baseline and are generally the largest lesions, most reliably measured and most representative of the participants sites of disease. Non target lesions are all of the sites of disease present at baseline not classified as target lesions. They include bone and cystic lesions and pleural/pericardial effusion/ascites. The Independent Radiology Reviewers (IRR) only evaluated scans for those with baseline and follow-up scans.
    param Type
    NUMBER
    title
    Number of Baseline Lesions (Target + Non-Target)
    unit Of Measure
    participants
population Description
For the Karnofsky Performance Status (KPS) baseline characteristic, some of the participants did not have a baseline KPS recorded by the clinical site.

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Preserved source evidence · Not medical advice