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NCT01847274 · BASELINE

Baseline characteristics

A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer · Source last updated 2023-06-02

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
      138
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      234
    4. group Id
      BG003
      value
      116
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      596
    units
    Participants
groups
  1. description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
    id
    BG000
    title
    gBRCA Niraparib
  2. description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
    id
    BG001
    title
    gBRCA Placebo
  3. description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
    id
    BG002
    title
    Non-gBRCA Niraparib
  4. description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
    id
    BG003
    title
    Non-gBRCA Placebo
  5. description
    Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods.
    id
    BG004
    title
    FE Sub-study: Fasted/Fed
  6. description
    Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods.
    id
    BG005
    title
    FE Sub-study: Fed/Fasted
  7. description
    Participants received Niraparib 300 mg once daily orally.
    id
    BG006
    title
    QTc Sub-study: Niraparib
  8. description
    Total of all reporting groups
    id
    BG007
    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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          69
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          384
        title
        Between 18 and 64 years
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          212
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          116
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          596
        title
        Female
      2. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          20
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          101
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          21
        8. group Id
          BG007
          value
          516
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The baseline analysis population was the intent-to-treat population, defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      138
    2. group Id
      BG001
      value
      65
    3. group Id
      BG002
      value
      234
    4. group Id
      BG003
      value
      116
    5. group Id
      BG004
      value
      8
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      26
    8. group Id
      BG007
      value
      596
    units
    Participants
groups
  1. description
    Participants with germline breast cancer gene (gBRCA) mutation received oral dose of niraparib 300 milligrams (mg) once daily in 28-day cycles until disease progression.
    id
    BG000
    title
    gBRCA Niraparib
  2. description
    Participants with germline BRCA mutation received oral dose of placebo matching niraparib once daily in 28-day cycles until disease progression.
    id
    BG001
    title
    gBRCA Placebo
  3. description
    Participants without germline BRCA mutation received oral dose of niraparib 300 mg once daily orally in 28-day cycles until disease progression.
    id
    BG002
    title
    Non-gBRCA Niraparib
  4. description
    Participants without germline BRCA mutation received matching placebo once daily orally in 28-day cycles until disease progression
    id
    BG003
    title
    Non-gBRCA Placebo
  5. description
    Participants received a single dose of 3x100 mg capsules of niraparib administered orally following a minimum 10-hour overnight fast in Period 1 followed by 300 mg capsules of niraparib administered orally as single dose in fed condition (high-fat meal) in Period 2. There was a washout period of 7 days between treatment periods.
    id
    BG004
    title
    FE Sub-study: Fasted/Fed
  6. description
    Participants received single dose of 3x100 mg capsules of niraparib administered orally following a high-fat meal in Period 1 followed by 3x100 mg capsules of niraparib administered orally as single dose in fasted condition in Period 2. There was a washout period of 7 days between treatment periods.
    id
    BG005
    title
    FE Sub-study: Fed/Fasted
  7. description
    Participants received Niraparib 300 mg once daily orally.
    id
    BG006
    title
    QTc Sub-study: Niraparib
  8. description
    Total of all reporting groups
    id
    BG007
    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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          130
        4. group Id
          BG003
          value
          69
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          16
        8. group Id
          BG007
          value
          384
        title
        Between 18 and 64 years
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          104
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          212
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          234
        4. group Id
          BG003
          value
          116
        5. group Id
          BG004
          value
          8
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          26
        8. group Id
          BG007
          value
          596
        title
        Female
      2. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          20
        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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          11
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          123
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          201
        4. group Id
          BG003
          value
          101
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          21
        8. group Id
          BG007
          value
          516
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          46
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The baseline analysis population was the intent-to-treat population, defined as all randomized participants with participants analyzed according to the study drug assigned via randomization

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice