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NCT02489903 · BASELINE

Baseline characteristics

RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT) · Source last updated 2025-03-17

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
      94
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      107
    units
    Participants
groups
  1. description
    4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
    id
    BG000
    title
    RRx-001 + Platinum Doublet (A01-09)
  2. description
    RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
    id
    BG001
    title
    RRx-001 + Platinum + RRx-001 (A10)
  3. description
    Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
    id
    BG002
    title
    Investigator's Choice (A10)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.3
          value
          61.4
        2. group Id
          BG001
          spread
          6.1
          value
          61.3
        3. group Id
          BG002
          spread
          2.8
          value
          75.0
        4. group Id
          BG003
          spread
          10.9
          value
          61.6
    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
          48
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          51
        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
          0
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          100
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          85
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          107
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Safety Population comprises all subjects who are randomized and received at least 1 dose of study drug and will be used for all analyses of safety. Analysis is based on actual treatment group
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      94
    2. group Id
      BG001
      value
      11
    3. group Id
      BG002
      value
      2
    4. group Id
      BG003
      value
      107
    units
    Participants
groups
  1. description
    4mg RRx-001 once weekly (QW) until progression, followed by up to 6 cycles of platinum doublet chemotherapy
    id
    BG000
    title
    RRx-001 + Platinum Doublet (A01-09)
  2. description
    RRx-001 weekly for 3 weeks followed by up to 6 cycles of platinum doublet chemotherapy and then RRx-001 maintenance (for patients with stable disease (SD) or better at discontinuation of platinum).
    id
    BG001
    title
    RRx-001 + Platinum + RRx-001 (A10)
  3. description
    Standard of Care Investigator's Choice Control Arm, treatment options of one of the following: carboplatin, etoposide, doxil, gemcitabine, vinorelbine or taxane treatments until progression or intolerable toxicity
    id
    BG002
    title
    Investigator's Choice (A10)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.3
          value
          61.4
        2. group Id
          BG001
          spread
          6.1
          value
          61.3
        3. group Id
          BG002
          spread
          2.8
          value
          75.0
        4. group Id
          BG003
          spread
          10.9
          value
          61.6
    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
          48
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          51
        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
          0
        4. group Id
          BG003
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          100
        title
        Not Hispanic or Latino
      3. 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
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. 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
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          85
        title
        White
      6. 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
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          94
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          107
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Safety Population comprises all subjects who are randomized and received at least 1 dose of study drug and will be used for all analyses of safety. Analysis is based on actual treatment group

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Preserved source evidence · Not medical advice