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NCT04111107 · BASELINE

Baseline characteristics

Precision Medicine for Patients With Identified Actionable Mutations · Source last updated 2024-07-03

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
      45
    units
    Participants
groups
  1. description
    Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
    id
    BG000
    title
    Drug Administration Based on Next Gen Sequencing Report
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          28
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          66
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Caucasian/White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      African American/Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic/Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Lung
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Head and Neck
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Other
    description
    Not all participants had the same type of cancer. This measure is a grouping of the disease site. 'Head and Neck' includes hypopharynx, oropharynx, larynx, tonsil and tongue, salivary gland, thyroid, nasal cavity and brain. 'Other' includes ampulla of vater, intrahepatic bile duct, duodenum, prostate, rectum and skin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Site
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      45
    units
    Participants
groups
  1. description
    Investigators will select the first drug listed in the tumor analysis report for the first mutation listed in the tumor analysis report. However, If the subject has a medical contraindication to the first listed drug (according to the drug label) or the first listed drug cannot be obtained for the patient, the study team will select the next drug presented by the tumor sequencing report. Patients receive targeted therapy based on next generation sequencing report. Cycles repeat every 2, 4, or 6 weeks in the absence of disease progression or unacceptable toxicity. Investigational Agent: Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label. Supportive Care Regimens: Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion. Next Gen Sequencing Report: 1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
    id
    BG000
    title
    Drug Administration Based on Next Gen Sequencing Report
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          17
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          28
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.3
          value
          66
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          31
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
      title
      Caucasian/White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      African American/Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Hispanic/Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          45
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      Lung
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      Head and Neck
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Other
    description
    Not all participants had the same type of cancer. This measure is a grouping of the disease site. 'Head and Neck' includes hypopharynx, oropharynx, larynx, tonsil and tongue, salivary gland, thyroid, nasal cavity and brain. 'Other' includes ampulla of vater, intrahepatic bile duct, duodenum, prostate, rectum and skin.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Site
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice