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NCT02928224 · BASELINE

Baseline characteristics

Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer · Source last updated 2023-12-21

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
      37
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      220
    4. group Id
      BG003
      value
      221
    5. group Id
      BG004
      value
      702
    units
    Participants
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    BG000
    title
    Combined Safety Lead-in (CSLI)
  2. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    BG001
    title
    Phase 3: Triplet Arm
  3. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    BG002
    title
    Phase 3: Doublet Arm
  4. description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    BG003
    title
    Phase 3: Control Arm
  5. description
    Total of all reporting groups
    id
    BG004
    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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          149
        5. group Id
          BG004
          value
          450
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          72
        5. group Id
          BG004
          value
          252
        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
          10.34
          value
          58.3
        2. group Id
          BG001
          spread
          11.65
          value
          59.5
        3. group Id
          BG002
          spread
          11.65
          value
          60.2
        4. group Id
          BG003
          spread
          12.07
          value
          58.4
        5. group Id
          BG004
          spread
          11.80
          value
          59.3
    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
          22
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          127
        5. group Id
          BG004
          value
          374
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          114
        4. group Id
          BG003
          value
          94
        5. group Id
          BG004
          value
          328
        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
          14
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          195
        4. group Id
          BG003
          value
          202
        5. group Id
          BG004
          value
          637
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          32
        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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          91
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          183
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          579
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          28
        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
          5
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          92
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          145
        4. group Id
          BG003
          value
          125
        5. group Id
          BG004
          value
          445
        title
        Europe
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          165
        title
        Rest of World
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          112
        4. group Id
          BG003
          value
          108
        5. group Id
          BG004
          value
          358
        title
        0-Fully active
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          340
        title
        1-Restircted in physically strenuous activity
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        2-Ambulatory and capable of all self-care
    description
    ECOG PS was used to assess the physical health of participants, and ranges from 0 to 5 where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          68
        5. group Id
          BG004
          value
          241
        title
        Left Colon
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          110
        4. group Id
          BG003
          value
          119
        5. group Id
          BG004
          value
          378
        title
        Right Colon
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          41
        title
        Left and Right Colon
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          42
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Primary Tumor Location
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          122
        5. group Id
          BG004
          value
          398
        title
        Completely Resected
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          97
        4. group Id
          BG003
          value
          99
        5. group Id
          BG004
          value
          304
        title
        Partially Resected/Unresected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Removal of Primary Tumor
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          123
        5. group Id
          BG004
          value
          370
        title
        <=2
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          98
        5. group Id
          BG004
          value
          332
        title
        3+
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Number of Organs Involved
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          128
        5. group Id
          BG004
          value
          431
      title
      Liver
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          265
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          273
      title
      Lymph Node
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          97
        4. group Id
          BG003
          value
          93
        5. group Id
          BG004
          value
          284
      title
      Peritoneum/Omentum
    description
    One participant may have more than one site of metastases.
    param Type
    NUMBER
    title
    Sites of Metastases
    unit Of Measure
    Sites
population Description
The baseline analysis population consists of the Full Analysis Set (FAS). For participants in the CSLI, the FAS includes all participants who received at least 1 dose of study drug and had at least 1 post treatment assessment, which may include death. For the randomized Phase 3 portion of the study, the FAS consists of all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      37
    2. group Id
      BG001
      value
      224
    3. group Id
      BG002
      value
      220
    4. group Id
      BG003
      value
      221
    5. group Id
      BG004
      value
      702
    units
    Participants
groups
  1. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    BG000
    title
    Combined Safety Lead-in (CSLI)
  2. description
    Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
    id
    BG001
    title
    Phase 3: Triplet Arm
  3. description
    Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
    id
    BG002
    title
    Phase 3: Doublet Arm
  4. description
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.
    id
    BG003
    title
    Phase 3: Control Arm
  5. description
    Total of all reporting groups
    id
    BG004
    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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          149
        5. group Id
          BG004
          value
          450
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          72
        5. group Id
          BG004
          value
          252
        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
          10.34
          value
          58.3
        2. group Id
          BG001
          spread
          11.65
          value
          59.5
        3. group Id
          BG002
          spread
          11.65
          value
          60.2
        4. group Id
          BG003
          spread
          12.07
          value
          58.4
        5. group Id
          BG004
          spread
          11.80
          value
          59.3
    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
          22
        2. group Id
          BG001
          value
          119
        3. group Id
          BG002
          value
          106
        4. group Id
          BG003
          value
          127
        5. group Id
          BG004
          value
          374
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          114
        4. group Id
          BG003
          value
          94
        5. group Id
          BG004
          value
          328
        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
          14
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          33
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          195
        4. group Id
          BG003
          value
          202
        5. group Id
          BG004
          value
          637
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          32
        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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          39
        5. group Id
          BG004
          value
          91
        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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          183
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          579
        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
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          28
        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
          5
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          92
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          150
        3. group Id
          BG002
          value
          145
        4. group Id
          BG003
          value
          125
        5. group Id
          BG004
          value
          445
        title
        Europe
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          47
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          165
        title
        Rest of World
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          116
        3. group Id
          BG002
          value
          112
        4. group Id
          BG003
          value
          108
        5. group Id
          BG004
          value
          358
        title
        0-Fully active
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          113
        5. group Id
          BG004
          value
          340
        title
        1-Restircted in physically strenuous activity
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        2-Ambulatory and capable of all self-care
    description
    ECOG PS was used to assess the physical health of participants, and ranges from 0 to 5 where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          68
        5. group Id
          BG004
          value
          241
        title
        Left Colon
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          110
        4. group Id
          BG003
          value
          119
        5. group Id
          BG004
          value
          378
        title
        Right Colon
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          22
        5. group Id
          BG004
          value
          41
        title
        Left and Right Colon
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          42
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Primary Tumor Location
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          133
        3. group Id
          BG002
          value
          123
        4. group Id
          BG003
          value
          122
        5. group Id
          BG004
          value
          398
        title
        Completely Resected
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          97
        4. group Id
          BG003
          value
          99
        5. group Id
          BG004
          value
          304
        title
        Partially Resected/Unresected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Removal of Primary Tumor
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          123
        5. group Id
          BG004
          value
          370
        title
        <=2
      2. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          98
        5. group Id
          BG004
          value
          332
        title
        3+
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Participants According to Number of Organs Involved
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          134
        4. group Id
          BG003
          value
          128
        5. group Id
          BG004
          value
          431
      title
      Liver
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          86
        5. group Id
          BG004
          value
          265
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          82
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          273
      title
      Lymph Node
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          77
        3. group Id
          BG002
          value
          97
        4. group Id
          BG003
          value
          93
        5. group Id
          BG004
          value
          284
      title
      Peritoneum/Omentum
    description
    One participant may have more than one site of metastases.
    param Type
    NUMBER
    title
    Sites of Metastases
    unit Of Measure
    Sites
population Description
The baseline analysis population consists of the Full Analysis Set (FAS). For participants in the CSLI, the FAS includes all participants who received at least 1 dose of study drug and had at least 1 post treatment assessment, which may include death. For the randomized Phase 3 portion of the study, the FAS consists of all randomized participants.

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Preserved source evidence · Independent clinical review pending · Not medical advice