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NCT00920556 · BASELINE

Baseline characteristics

A Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination With Bortezomib in Patients With Multiple Myeloma · Source last updated 2019-02-27

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
      24
    units
    Participants
groups
  1. description
    Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited progressive disease (PD), then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
    id
    BG000
    title
    Overall Study
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.83
          value
          66.4
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
        title
        Afro-Caribbean
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        Caucasian
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      24
    units
    Participants
groups
  1. description
    Eligible participants were administered 5 gram (g) of SRT501, as oral suspension every morning approximately 15-30 minutes after breakfast), for 20 days in 21-day cycle, for max period of 12 cycles (Not administered on Day 21 of each cycle). Post first two cycles, participant who exhibited stable disease (SD) or better, with SRT501 monotherapy, continued for additional two cycles. If, after first 2 cycles, participant exhibited progressive disease (PD), then received bortezomib (1.3 milligram(mg)/meter square (m\^2)on Day 1, Day 4, Day 8, and Day 11 in a 21 day cycle) along with SRT501. Bortezomib was administered intravenous suspension, prior to breakfast and SRT501 administration. If after 2 additional cycles of SRT501 monotherapy (4 cycles total), participant exhibited SD or better, they remained on SRT501 therapy, until judged to have PD. If PD,participants underwent bortezomib regiment as above. At any point of (SRT501+Bortezoimb),participant was assessed with PD, was discontinued
    id
    BG000
    title
    Overall Study
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.83
          value
          66.4
    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
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
        title
        Afro-Caribbean
      2. measurements
        1. group Id
          BG000
          value
          21
        title
        Caucasian
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice