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NCT03509207 · BASELINE

Baseline characteristics

Vorinostat (SAHA) in Uterine Sarcoma · Source last updated 2020-08-04

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
      3
    units
    Participants
groups
  1. description
    Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
    id
    BG000
    title
    Vorinostat, Zolinza Oral Capsules
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
      title
      Austria
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Statistical evaluation was not possible as only 1 Patient reached end point 1.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    units
    Participants
groups
  1. description
    Vorinostat Oral Capsules 400mg daily Vorinostat Oral Capsule: Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
    id
    BG000
    title
    Vorinostat, Zolinza Oral Capsules
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        >=65 years
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        units
        Participants
      title
      Austria
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Statistical evaluation was not possible as only 1 Patient reached end point 1.

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Preserved source evidence · Not medical advice