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NCT01494506 · BASELINE

Baseline characteristics

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer · Source last updated 2016-06-17

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
      151
    2. group Id
      BG001
      value
      149
    3. group Id
      BG002
      value
      117
    4. group Id
      BG003
      value
      417
    units
    Participants
groups
  1. description
    MM-398 Q3W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W
    id
    BG000
    title
    MM-398
  2. description
    5 Fluorouracil and Leucovorin IV 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    BG001
    title
    5 Fluorouracil and Leucovorin IV
  3. description
    MM-398, 5-FU and Leucovorin Q2W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    BG002
    title
    MM-398, 5-FU and Leucovorin
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          417
        title
        Between 18 and 65 years
      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
        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
          10.13
          value
          63.6
        2. group Id
          BG001
          spread
          9.65
          value
          61.8
        3. group Id
          BG002
          spread
          9.06
          value
          63.2
        4. group Id
          BG003
          spread
          9.68
          value
          62.8
    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
          64
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          237
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          136
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          253
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          17
      title
      other race
    param Type
    NUMBER
    title
    RACE (NIH/OMB)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          62
      title
      100% = normal, no complaints, no signs of disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          169
      title
      90% = normal activity, few symptoms of disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          149
      title
      80% = normal activity, some symptoms of disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          33
      title
      70% = caring for self, unable to work
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      title
      60% [2] = 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
          1
        4. group Id
          BG003
          value
          1
      title
      50%[2]= needs help often and medical care
    7. 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
          1
      title
      Not recorded
    description
    1. One patient in the 5-FU/LV arm did not have a recorded Baseline KPS value. 2. Designation of the KPS level for the randomization strata is made during the screening period prior to knowledge of the treatment assignment. Baseline KPS is the last observed KPS value prior to treatment in treated patients and the last observed value in patients who were randomized and did not receive study drug. The observed baseline KPS value may be recorded post-randomization.
    param Type
    NUMBER
    title
    Karnofsky Performance Status (Baseline KPS)[1]
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          239
      title
      Head
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          54
      title
      Body
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          62
      title
      Tail
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          17
      title
      Multiple locations including head
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
      title
      Multiple locations not including head
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Unknown = not specified
    param Type
    NUMBER
    title
    Pancreatic Primary Tumor Location
    unit Of Measure
    participants
population Description
All randomized patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      151
    2. group Id
      BG001
      value
      149
    3. group Id
      BG002
      value
      117
    4. group Id
      BG003
      value
      417
    units
    Participants
groups
  1. description
    MM-398 Q3W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W
    id
    BG000
    title
    MM-398
  2. description
    5 Fluorouracil and Leucovorin IV 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    BG001
    title
    5 Fluorouracil and Leucovorin IV
  3. description
    MM-398, 5-FU and Leucovorin Q2W IV MM-398: Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W 5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
    id
    BG002
    title
    MM-398, 5-FU and Leucovorin
  4. description
    Total of all reporting groups
    id
    BG003
    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
        4. group Id
          BG003
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          417
        title
        Between 18 and 65 years
      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
        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
          10.13
          value
          63.6
        2. group Id
          BG001
          spread
          9.65
          value
          61.8
        3. group Id
          BG002
          spread
          9.06
          value
          63.2
        4. group Id
          BG003
          spread
          9.68
          value
          62.8
    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
          64
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          180
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          81
        3. group Id
          BG002
          value
          69
        4. group Id
          BG003
          value
          237
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      American Indian or Alaska Native
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          52
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          136
      title
      Asian
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          89
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          72
        4. group Id
          BG003
          value
          253
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          17
      title
      other race
    param Type
    NUMBER
    title
    RACE (NIH/OMB)
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          62
      title
      100% = normal, no complaints, no signs of disease
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          51
        4. group Id
          BG003
          value
          169
      title
      90% = normal activity, few symptoms of disease
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          149
      title
      80% = normal activity, some symptoms of disease
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          33
      title
      70% = caring for self, unable to work
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
      title
      60% [2] = 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
          1
        4. group Id
          BG003
          value
          1
      title
      50%[2]= needs help often and medical care
    7. 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
          1
      title
      Not recorded
    description
    1. One patient in the 5-FU/LV arm did not have a recorded Baseline KPS value. 2. Designation of the KPS level for the randomization strata is made during the screening period prior to knowledge of the treatment assignment. Baseline KPS is the last observed KPS value prior to treatment in treated patients and the last observed value in patients who were randomized and did not receive study drug. The observed baseline KPS value may be recorded post-randomization.
    param Type
    NUMBER
    title
    Karnofsky Performance Status (Baseline KPS)[1]
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          239
      title
      Head
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          54
      title
      Body
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          62
      title
      Tail
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          17
      title
      Multiple locations including head
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          30
      title
      Multiple locations not including head
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          15
      title
      Unknown = not specified
    param Type
    NUMBER
    title
    Pancreatic Primary Tumor Location
    unit Of Measure
    participants
population Description
All randomized patients.

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Preserved source evidence · Not medical advice