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NCT02598661 · BASELINE

Baseline characteristics

Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) · Source last updated 2026-07-17

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
      57
    2. group Id
      BG001
      value
      118
    3. group Id
      BG002
      value
      60
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      18
    6. group Id
      BG005
      value
      288
    units
    Participants
groups
  1. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
    id
    BG000
    title
    Phase 2: Imetelstat Sodium
  2. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG001
    title
    Phase 3: Imetelstat Sodium
  3. description
    Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG002
    title
    Phase 3: Placebo
  4. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG003
    title
    QTc Substudy: Imetelstat Sodium
  5. description
    Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
    id
    BG004
    title
    QTc Substudy: Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          83
          value
          70.1
        2. group Id
          BG001
          lower Limit
          44
          upper Limit
          87
          value
          70.4
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          85
          value
          71.7
        4. group Id
          BG003
          lower Limit
          43
          upper Limit
          84
          value
          69.7
        5. group Id
          BG004
          lower Limit
          54
          upper Limit
          81
          value
          67.8
        6. group Id
          BG005
          lower Limit
          39
          upper Limit
          87
          value
          69.9
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          102
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          186
        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
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          240
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          36
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          233
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: Intent-to-Treat (ITT) Analysis Set included all participants randomized into the phase 3 study. The QTc Substudy Analysis Set included all participants who participated in QTc Substudy and received at least one dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      57
    2. group Id
      BG001
      value
      118
    3. group Id
      BG002
      value
      60
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      18
    6. group Id
      BG005
      value
      288
    units
    Participants
groups
  1. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. Dose escalation to 9.4 mg/kg was allowed before Protocol Amendment 2.
    id
    BG000
    title
    Phase 2: Imetelstat Sodium
  2. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG001
    title
    Phase 3: Imetelstat Sodium
  3. description
    Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG002
    title
    Phase 3: Placebo
  4. description
    Imetelstat sodium administered IV, at a starting dose of 7.5 mg/kg, every 4 weeks (on a 28-day cycle) until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first.
    id
    BG003
    title
    QTc Substudy: Imetelstat Sodium
  5. description
    Imetelstat sodium-matching placebo administered IV, every 4 weeks (on a 28-day cycle), until death, lost to follow-up, withdrawal of consent, or study termination whichever occurs first. If after a minimum of 2 treatment cycles a participant has no significant change to pRBC transfusion burden or evidence of clinical benefit per Investigator, after discussion with the Sponsor the participant, he/she may be permitted to start treatment with imetelstat sodium.
    id
    BG004
    title
    QTc Substudy: Placebo
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          46
          upper Limit
          83
          value
          70.1
        2. group Id
          BG001
          lower Limit
          44
          upper Limit
          87
          value
          70.4
        3. group Id
          BG002
          lower Limit
          39
          upper Limit
          85
          value
          71.7
        4. group Id
          BG003
          lower Limit
          43
          upper Limit
          84
          value
          69.7
        5. group Id
          BG004
          lower Limit
          54
          upper Limit
          81
          value
          67.8
        6. group Id
          BG005
          lower Limit
          39
          upper Limit
          87
          value
          69.9
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          102
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          40
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          186
        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
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          48
        2. group Id
          BG001
          value
          100
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          240
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          36
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          48
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          233
        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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          34
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Phase 2: All Treated Analysis Set included all participants who received at least one dose of study drug. Phase 3: Intent-to-Treat (ITT) Analysis Set included all participants randomized into the phase 3 study. The QTc Substudy Analysis Set included all participants who participated in QTc Substudy and received at least one dose of study drug.

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Preserved source evidence · Not medical advice