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NCT02457793 · BASELINE

Baseline characteristics

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors · Source last updated 2018-11-20

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
      1
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      24
    units
    Participants
groups
  1. description
    One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
    id
    BG000
    title
    Not Assigned
  2. description
    Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG001
    title
    COB 20 mg + GDC 200 mg
  3. description
    Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG002
    title
    COB 40 mg + GDC 200 mg
  4. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG003
    title
    COB 80 mg + GDC 200 mg
  5. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
    id
    BG004
    title
    COB 80 mg + GDC 400 mg
  6. description
    Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG005
    title
    COB 100 mg + GDC 200 mg
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9999
          value
          48.0
        2. group Id
          BG001
          spread
          11.5
          value
          53.0
        3. group Id
          BG002
          spread
          11.0
          value
          57.3
        4. group Id
          BG003
          spread
          14.2
          value
          51.6
        5. group Id
          BG004
          spread
          5.6
          value
          52.3
        6. group Id
          BG005
          spread
          11.5
          value
          59.7
        7. group Id
          BG006
          spread
          10.7
          value
          54.6
    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
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          17
        title
        Female
      2. 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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      6
    7. group Id
      BG006
      value
      24
    units
    Participants
groups
  1. description
    One participant was assigned to receive intermittent cobimetinib 80 milligrams (mg) + GDC 0994 200 mg) and did receive study drug. However, the participant diary was not returned, and the site was unable to document study dose administration.
    id
    BG000
    title
    Not Assigned
  2. description
    Concurrent or intermittent dosing of cobimetinib 20 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG001
    title
    COB 20 mg + GDC 200 mg
  3. description
    Concurrent or intermittent dosing of cobimetinib 40 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG002
    title
    COB 40 mg + GDC 200 mg
  4. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG003
    title
    COB 80 mg + GDC 200 mg
  5. description
    Concurrent or intermittent dosing of cobimetinib 80 mg, concurrent with GDC-0994 400 mg for 21 consecutive days, followed by 7 days off.
    id
    BG004
    title
    COB 80 mg + GDC 400 mg
  6. description
    Concurrent or intermittent dosing of cobimetinib 100 mg, concurrent with GDC-0994 200 mg for 21 consecutive days, followed by 7 days off.
    id
    BG005
    title
    COB 100 mg + GDC 200 mg
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9999
          value
          48.0
        2. group Id
          BG001
          spread
          11.5
          value
          53.0
        3. group Id
          BG002
          spread
          11.0
          value
          57.3
        4. group Id
          BG003
          spread
          14.2
          value
          51.6
        5. group Id
          BG004
          spread
          5.6
          value
          52.3
        6. group Id
          BG005
          spread
          11.5
          value
          59.7
        7. group Id
          BG006
          spread
          10.7
          value
          54.6
    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
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          17
        title
        Female
      2. 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
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          7
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice