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NCT02655016 · BASELINE

Baseline characteristics

A Study of Niraparib (GSK3985771) Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy · Source last updated 2026-03-10

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
      246
    2. group Id
      BG001
      value
      487
    3. group Id
      BG002
      value
      733
    units
    Participants
groups
  1. description
    Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
    id
    BG000
    title
    Placebo
  2. description
    Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
    id
    BG001
    title
    Niraparib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.39
          value
          61.3
        2. group Id
          BG001
          spread
          10.79
          value
          61.1
        3. group Id
          BG002
          spread
          10.65
          value
          61.2
    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
          246
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          733
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          219
        2. group Id
          BG001
          value
          436
        3. group Id
          BG002
          value
          655
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          12
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          39
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline characteristics were presented for all randomized participants including 5 randomized participants who never received treatment (4-Screen failure and 1-Withdrew consent).
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      246
    2. group Id
      BG001
      value
      487
    3. group Id
      BG002
      value
      733
    units
    Participants
groups
  1. description
    Participants received placebo matching niraparib 300 milligram (mg) (3×100 mg capsules) (fixed dose) once daily (QD) orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received placebo based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kilogram \[kg\] and Baseline platelet count \>=150,000 per microliter \[μL\]) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
    id
    BG000
    title
    Placebo
  2. description
    Participants received niraparib 300 mg (3×100 mg capsules) (fixed dose) QD orally beginning on Day 1 of every cycle (each cycle of 28-days) in a double-blind fashion until a modified starting dose regimen was implemented in protocol amendment. After the protocol amendment, participants received niraparib based upon the participant's Baseline body weight or Baseline platelet count (individualized dose): 300 mg (3×100 mg capsules for participants with a Baseline body weight \>=77 kg and Baseline platelet count \>=150,000 per μL) or 200 mg (2×100 mg capsules for participants with a Baseline body weight \<77 kg or Baseline platelet count \<150,000 per μL).
    id
    BG001
    title
    Niraparib
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.39
          value
          61.3
        2. group Id
          BG001
          spread
          10.79
          value
          61.1
        3. group Id
          BG002
          spread
          10.65
          value
          61.2
    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
          246
        2. group Id
          BG001
          value
          487
        3. group Id
          BG002
          value
          733
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          219
        2. group Id
          BG001
          value
          436
        3. group Id
          BG002
          value
          655
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          12
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          25
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          39
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline characteristics were presented for all randomized participants including 5 randomized participants who never received treatment (4-Screen failure and 1-Withdrew consent).

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

Preserved source evidence · Not medical advice