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NCT02470585 · BASELINE

Baseline characteristics

Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2024-10-26

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
      383
    3. group Id
      BG002
      value
      382
    4. group Id
      BG003
      value
      1140
    units
    Participants
groups
  1. description
    Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG000
    title
    Placebo + Carboplatin + Paclitaxel -> Placebo
  2. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG001
    title
    Veliparib + Carboplatin + Paclitaxel -> Placebo
  3. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG002
    title
    Veliparib + Carboplatin + Paclitaxel -> Veliparib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33.0
          upper Limit
          86.0
          value
          62.0
        2. group Id
          BG001
          lower Limit
          22.0
          upper Limit
          88.0
          value
          62.0
        3. group Id
          BG002
          lower Limit
          30.0
          upper Limit
          85.0
          value
          62.0
        4. group Id
          BG003
          lower Limit
          22.0
          upper Limit
          88.0
          value
          62.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    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
          233
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          228
        4. group Id
          BG003
          value
          687
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          453
        title
        ≥ 65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        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
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          81
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          347
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          356
        4. group Id
          BG003
          value
          1059
        title
        Not Hispanic or Latino
      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
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          297
        3. group Id
          BG002
          value
          300
        4. group Id
          BG003
          value
          896
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          43
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          184
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Native Hawaiian or other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Multi-race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          267
        4. group Id
          BG003
          value
          794
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          78
        title
        Japan
      3. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          268
        title
        Rest of World
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          298
        title
        Germline or tissue BRCA1/2 mutation
      2. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          245
        4. group Id
          BG003
          value
          742
        title
        Germline or tissue BRCA1/2 wildtype
      3. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          100
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BRCA-Deficient Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          214
        4. group Id
          BG003
          value
          627
        title
        HRD
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          125
        4. group Id
          BG003
          value
          372
        title
        Non-HRD
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          141
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of \< 33 was considered to indicate non-HRD status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Homologous Recombination Deficiency (HRD) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          295
        4. group Id
          BG003
          value
          875
        title
        Stage III
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          263
        title
        Stage IV
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing. STAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes. STAGE IV: Distant metastases excluding peritoneal metastases
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Disease
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          764
        title
        Primary
      2. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          320
        title
        Interval
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          56
        title
        No surgery received
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Surgery Received
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          124
        4. group Id
          BG003
          value
          358
        title
        No residual disease
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          158
        title
        Microscopic residual disease only
      3. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          248
        title
        Any macroscopic residual disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          764
        units
        Participants
    description
    Data were collected after interval surgery after cycle 3.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Participants who underwent primary surgery
    title
    Residual Disease After Primary Surgery
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          141
        title
        No residual disease
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          76
        title
        Microscopic residual disease only
      3. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          92
        title
        Any macroscopic residual disease
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          320
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Participants who underwent interval surgery
    title
    Residual Disease After Interval Surgery
    unit Of Measure
    Participants
population Description
The intention-to-treat (ITT) population consisted of all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      375
    2. group Id
      BG001
      value
      383
    3. group Id
      BG002
      value
      382
    4. group Id
      BG003
      value
      1140
    units
    Participants
groups
  1. description
    Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve \[AUC\] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG000
    title
    Placebo + Carboplatin + Paclitaxel -> Placebo
  2. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG001
    title
    Veliparib + Carboplatin + Paclitaxel -> Placebo
  3. description
    Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks, and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    id
    BG002
    title
    Veliparib + Carboplatin + Paclitaxel -> Veliparib
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          33.0
          upper Limit
          86.0
          value
          62.0
        2. group Id
          BG001
          lower Limit
          22.0
          upper Limit
          88.0
          value
          62.0
        3. group Id
          BG002
          lower Limit
          30.0
          upper Limit
          85.0
          value
          62.0
        4. group Id
          BG003
          lower Limit
          22.0
          upper Limit
          88.0
          value
          62.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    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
          233
        2. group Id
          BG001
          value
          226
        3. group Id
          BG002
          value
          228
        4. group Id
          BG003
          value
          687
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          142
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          453
        title
        ≥ 65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        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
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          81
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          347
        2. group Id
          BG001
          value
          356
        3. group Id
          BG002
          value
          356
        4. group Id
          BG003
          value
          1059
        title
        Not Hispanic or Latino
      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
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          299
        2. group Id
          BG001
          value
          297
        3. group Id
          BG002
          value
          300
        4. group Id
          BG003
          value
          896
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          43
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          69
        3. group Id
          BG002
          value
          56
        4. group Id
          BG003
          value
          184
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        title
        Native Hawaiian or other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Multi-race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          266
        2. group Id
          BG001
          value
          261
        3. group Id
          BG002
          value
          267
        4. group Id
          BG003
          value
          794
        title
        North America
      2. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          78
        title
        Japan
      3. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          268
        title
        Rest of World
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          108
        4. group Id
          BG003
          value
          298
        title
        Germline or tissue BRCA1/2 mutation
      2. measurements
        1. group Id
          BG000
          value
          254
        2. group Id
          BG001
          value
          243
        3. group Id
          BG002
          value
          245
        4. group Id
          BG003
          value
          742
        title
        Germline or tissue BRCA1/2 wildtype
      3. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          100
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    The BRCA-mutation cohort was defined as participants who had deleterious or suspected deleterious germline (gBRCA) or tissue-based (tBRCA) mutations as determined by the Myriad BRACAnalysis® companion diagnostic (CDx) or myChoice® HRD CDx assay, respectively, in BRCA1 or BRCA2.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    BRCA-Deficient Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          207
        2. group Id
          BG001
          value
          206
        3. group Id
          BG002
          value
          214
        4. group Id
          BG003
          value
          627
        title
        HRD
      2. measurements
        1. group Id
          BG000
          value
          124
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          125
        4. group Id
          BG003
          value
          372
        title
        Non-HRD
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          54
        3. group Id
          BG002
          value
          43
        4. group Id
          BG003
          value
          141
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    The HRD cohort consisted of participants who had tumors that were BRCA-mutated or had HRD according to the Myriad myChoice® assay, on which a score of ≥ 33 was considered to indicate HRD status, and a score of \< 33 was considered to indicate non-HRD status.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Homologous Recombination Deficiency (HRD) Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          292
        2. group Id
          BG001
          value
          288
        3. group Id
          BG002
          value
          295
        4. group Id
          BG003
          value
          875
        title
        Stage III
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          87
        4. group Id
          BG003
          value
          263
        title
        Stage IV
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    Staging of primary ovarian carcinomas according to the International Federation of Gynecology and Obstetrics (FIGO) criteria, based on clinical examination, surgical exploration, histologic characteristics and cytologic testing. STAGE III: Tumor involves 1 or both ovaries with cytologically or histologically confirmed spread to the peritoneum outside the pelvis and/or metastases to the retroperitoneal lymph nodes. STAGE IV: Distant metastases excluding peritoneal metastases
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage of Disease
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          764
        title
        Primary
      2. measurements
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          320
        title
        Interval
      3. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          56
        title
        No surgery received
      denoms
      1. counts
        1. group Id
          BG000
          value
          375
        2. group Id
          BG001
          value
          383
        3. group Id
          BG002
          value
          382
        4. group Id
          BG003
          value
          1140
        units
        Participants
    description
    Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval), determined at the discretion of the investigator.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Surgery Received
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          124
        4. group Id
          BG003
          value
          358
        title
        No residual disease
      2. measurements
        1. group Id
          BG000
          value
          58
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          54
        4. group Id
          BG003
          value
          158
        title
        Microscopic residual disease only
      3. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          83
        4. group Id
          BG003
          value
          248
        title
        Any macroscopic residual disease
      denoms
      1. counts
        1. group Id
          BG000
          value
          250
        2. group Id
          BG001
          value
          253
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          764
        units
        Participants
    description
    Data were collected after interval surgery after cycle 3.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Participants who underwent primary surgery
    title
    Residual Disease After Primary Surgery
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          45
        4. group Id
          BG003
          value
          141
        title
        No residual disease
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          76
        title
        Microscopic residual disease only
      3. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          92
        title
        Any macroscopic residual disease
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          107
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          320
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Participants who underwent interval surgery
    title
    Residual Disease After Interval Surgery
    unit Of Measure
    Participants
population Description
The intention-to-treat (ITT) population consisted of all randomized participants.

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Preserved source evidence · Not medical advice