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NCT01891344 · FLOW

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A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) · Source last updated 2023-06-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. Part 1 enrolled patients who received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG000
    title
    Part 1: tBRCA
  2. description
    Patients without a BRCA mutation in their tumor, but have high LOH (loss of heterozygosity). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG001
    title
    Part 1: Non-tBRCA LOH+
  3. description
    Patients without a BRCA mutation in their tumor, but have low LOH. Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG002
    title
    Part 1: Non-tBRCA LOH-
  4. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG003
    title
    Part 1: Non-tBRCA LOH Unknown
  5. description
    Patients with a deleterious BRCA mutation detected in their tumor. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG004
    title
    Part 2: tBRCA
  6. description
    Patients without a BRCA mutation in their tumor, but have high LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG005
    title
    Part 2: Non-tBRCA LOH+
  7. description
    Patients without a BRCA mutation in their tumor, but have low LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG006
    title
    Part 2: Non-tBRCA LOH-
  8. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG007
    title
    Part 2: Non-tBRCA LOH Unknown
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        82
      3. group Id
        FG002
        num Subjects
        70
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        84
      6. group Id
        FG005
        num Subjects
        73
      7. group Id
        FG006
        num Subjects
        107
      8. group Id
        FG007
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        70
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        80
      6. group Id
        FG005
        num Subjects
        72
      7. group Id
        FG006
        num Subjects
        107
      8. group Id
        FG007
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
491 subjects were recruited from 64 sites across 6 countries.
Complete source fields
groups
  1. description
    Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor. Part 1 enrolled patients who received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG000
    title
    Part 1: tBRCA
  2. description
    Patients without a BRCA mutation in their tumor, but have high LOH (loss of heterozygosity). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG001
    title
    Part 1: Non-tBRCA LOH+
  3. description
    Patients without a BRCA mutation in their tumor, but have low LOH. Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG002
    title
    Part 1: Non-tBRCA LOH-
  4. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 1 enrolled patients received ≥ 1 prior platinum-based regimen and had platinum-sensitive disease.
    id
    FG003
    title
    Part 1: Non-tBRCA LOH Unknown
  5. description
    Patients with a deleterious BRCA mutation detected in their tumor. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG004
    title
    Part 2: tBRCA
  6. description
    Patients without a BRCA mutation in their tumor, but have high LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG005
    title
    Part 2: Non-tBRCA LOH+
  7. description
    Patients without a BRCA mutation in their tumor, but have low LOH. Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG006
    title
    Part 2: Non-tBRCA LOH-
  8. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s). Part 2 enrolled patients who received at least 3, but no more than 4, prior chemotherapy regimens.
    id
    FG007
    title
    Part 2: Non-tBRCA LOH Unknown
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        40
      2. group Id
        FG001
        num Subjects
        82
      3. group Id
        FG002
        num Subjects
        70
      4. group Id
        FG003
        num Subjects
        12
      5. group Id
        FG004
        num Subjects
        84
      6. group Id
        FG005
        num Subjects
        73
      7. group Id
        FG006
        num Subjects
        107
      8. group Id
        FG007
        num Subjects
        23
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        80
      3. group Id
        FG002
        num Subjects
        70
      4. group Id
        FG003
        num Subjects
        11
      5. group Id
        FG004
        num Subjects
        80
      6. group Id
        FG005
        num Subjects
        72
      7. group Id
        FG006
        num Subjects
        107
      8. group Id
        FG007
        num Subjects
        23
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
491 subjects were recruited from 64 sites across 6 countries.

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Preserved source evidence · Not medical advice