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NCT01968213 · BASELINE

Baseline characteristics

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) · Source last updated 2023-06-09

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
      375
    2. group Id
      BG001
      value
      189
    3. group Id
      BG002
      value
      564
    units
    Participants
groups
  1. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    BG000
    title
    Rucaparib 600 mg Tablets
  2. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    BG001
    title
    Placebo Tablets
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          84
          value
          61
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          85
          value
          62
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          85
          value
          61
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          189
        3. group Id
          BG002
          value
          564
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          436
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          75
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          190
        title
        RECIST CR
      2. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          374
        title
        RECIST / CA-125 PR
    description
    Complete and partial responses at baseline must have been reported according to RECIST v1.1, as assessed by CT/MRI, and GCIG CA-125 response criteria, and defined as: Complete Response (CR) i.e. absence of any detectable disease and CA-125\<ULN; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of measurable lesions or if non-measurable disease at baseline, a GCIG CA-125 response (least a 50% reduction in CA-125 levels from a pretreatment sample (which must have initially been 2xULN) and confirmed after ≥21 days). CA-125 must have been \<ULN for all PRs.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best Response from Previous Platinum Therapy
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          227
        title
        6-12 Months
      2. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          337
        title
        >12 Months
    description
    Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Penultimate Progression-free (PF) Interval
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          100
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          304
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          464
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bulky Lesions (lesion >20 mm) at Baseline
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      375
    2. group Id
      BG001
      value
      189
    3. group Id
      BG002
      value
      564
    units
    Participants
groups
  1. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    BG000
    title
    Rucaparib 600 mg Tablets
  2. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    BG001
    title
    Placebo Tablets
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          39
          upper Limit
          84
          value
          61
        2. group Id
          BG001
          lower Limit
          36
          upper Limit
          85
          value
          62
        3. group Id
          BG002
          lower Limit
          36
          upper Limit
          85
          value
          61
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          189
        3. group Id
          BG002
          value
          564
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          21
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          144
        3. group Id
          BG002
          value
          436
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          75
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          190
        title
        RECIST CR
      2. measurements
        1. group Id
          BG000
          value
          249
        2. group Id
          BG001
          value
          125
        3. group Id
          BG002
          value
          374
        title
        RECIST / CA-125 PR
    description
    Complete and partial responses at baseline must have been reported according to RECIST v1.1, as assessed by CT/MRI, and GCIG CA-125 response criteria, and defined as: Complete Response (CR) i.e. absence of any detectable disease and CA-125\<ULN; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of measurable lesions or if non-measurable disease at baseline, a GCIG CA-125 response (least a 50% reduction in CA-125 levels from a pretreatment sample (which must have initially been 2xULN) and confirmed after ≥21 days). CA-125 must have been \<ULN for all PRs.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Best Response from Previous Platinum Therapy
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          227
        title
        6-12 Months
      2. measurements
        1. group Id
          BG000
          value
          224
        2. group Id
          BG001
          value
          113
        3. group Id
          BG002
          value
          337
        title
        >12 Months
    description
    Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Penultimate Progression-free (PF) Interval
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          100
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          304
        2. group Id
          BG001
          value
          160
        3. group Id
          BG002
          value
          464
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bulky Lesions (lesion >20 mm) at Baseline
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice