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NCT02598661 · OUTCOME

Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period

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.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3.7 years in Phase 3

What was measured

Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.

Analysis population: Phase 3: The ITT Analysis Set included all participants randomized into the Phase 3 study.

Groups in this outcome

Phase 3: Imetelstat Sodium

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.

Phase 3: Placebo

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 3: Imetelstat Sodium118
Phase 3: Placebo60

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 3: Imetelstat Sodium39.8Not reported30.9349.25Not reported
Phase 3: Placebo15.0Not reported7.1026.57Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    9.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    36.89
    estimate Comment
    The 95% CI was calculated based on the Wilson Score method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.
    param Type
    Percentage Difference
    param Value
    24.8
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    9.90
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    36.89
    estimate Comment
    The 95% CI was calculated based on the Wilson Score method.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.001
    p Value Comment
    The p-value was calculated based on Cochran-Mantel-Haenszel (CMH) controlling for prior RBC transfusion burden (≤6 versus\[vs.\]\>6 units RBC) \& international prognostic scoring system (IPSS) risk group (low vs. intermediate-1) applied to randomization.
    param Type
    Percentage Difference
    param Value
    24.8
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.93
        upper Limit
        49.25
        value
        39.8
      2. group Id
        OG001
        lower Limit
        7.10
        upper Limit
        26.57
        value
        15.0
denoms
  1. counts
    1. group Id
      OG000
      value
      118
    2. group Id
      OG001
      value
      60
    units
    Participants
description
Percentage of participants without any RBC transfusion during any consecutive 8 weeks (56 days) starting from Study Day 1 until subsequent anti-cancer therapy if any were reported. Study Day 1 is defined as the day of the first dose for participants enrolled in Phase 2. The 95% CI was calculated using Clopper-Pearson method. Percentages were rounded off to the nearest single decimal place.
dispersion Type
95% Confidence Interval
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.
    id
    OG000
    title
    Phase 3: Imetelstat Sodium
  2. 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
    OG001
    title
    Phase 3: Placebo
param Type
NUMBER
population Description
Phase 3: The ITT Analysis Set included all participants randomized into the Phase 3 study.
reporting Status
POSTED
time Frame
Up to 3.7 years in Phase 3
title
Phase 3: Percentage of Participants Without Any RBC Transfusion During Any Consecutive 8-Weeks Period
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice