Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01907100 · BASELINE

Baseline characteristics

Nintedanib (BIBF 1120) in Mesothelioma · Source last updated 2019-03-18

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
      43
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      229
    4. group Id
      BG003
      value
      229
    5. group Id
      BG004
      value
      545
    units
    Participants
groups
  1. description
    Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG000
    title
    Placebo_Phase II
  2. description
    Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG001
    title
    Nintedanib_Phase II
  3. description
    Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG002
    title
    Placebo_Phase III
  4. description
    Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG003
    title
    Nintedanib_Phase III
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.6
          value
          65.9
        2. group Id
          BG001
          spread
          8.6
          value
          66.4
        3. group Id
          BG002
          spread
          8.9
          value
          64.3
        4. group Id
          BG003
          spread
          9.5
          value
          63.6
        5. group Id
          BG004
          spread
          9.1
          value
          64.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    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
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          64
        5. group Id
          BG004
          value
          142
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          169
        4. group Id
          BG003
          value
          165
        5. group Id
          BG004
          value
          403
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG004
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG004
          value
          0
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Ethnicity data were not collected from any participant
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          26
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          30
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          180
        4. group Id
          BG003
          value
          185
        5. group Id
          BG004
          value
          441
        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
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          46
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    description
    Race was only collected where allowed by local law.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Randomised Set: This patient set included all randomized patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      43
    2. group Id
      BG001
      value
      44
    3. group Id
      BG002
      value
      229
    4. group Id
      BG003
      value
      229
    5. group Id
      BG004
      value
      545
    units
    Participants
groups
  1. description
    Phase II part: Nintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG000
    title
    Placebo_Phase II
  2. description
    Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG001
    title
    Nintedanib_Phase II
  3. description
    Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG002
    title
    Placebo_Phase III
  4. description
    Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
    id
    BG003
    title
    Nintedanib_Phase III
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.6
          value
          65.9
        2. group Id
          BG001
          spread
          8.6
          value
          66.4
        3. group Id
          BG002
          spread
          8.9
          value
          64.3
        4. group Id
          BG003
          spread
          9.5
          value
          63.6
        5. group Id
          BG004
          spread
          9.1
          value
          64.3
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    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
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          60
        4. group Id
          BG003
          value
          64
        5. group Id
          BG004
          value
          142
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          169
        4. group Id
          BG003
          value
          165
        5. group Id
          BG004
          value
          403
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG004
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG004
          value
          0
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Ethnicity data were not collected from any participant
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          26
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          30
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          180
        4. group Id
          BG003
          value
          185
        5. group Id
          BG004
          value
          441
        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
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          46
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          229
        4. group Id
          BG003
          value
          229
        5. group Id
          BG004
          value
          545
        units
        Participants
    description
    Race was only collected where allowed by local law.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Randomised Set: This patient set included all randomized patients.

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

Preserved source evidence · Not medical advice