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NCT01437787 · OUTCOME

Percentage of Participants Who Had >=25% Reduction From Baseline in Volume of Spleen Size at End of Cycle 6

Phase III Study of SAR302503 in Intermediate-2 and High Risk Patients With Myelofibrosis · Source last updated 2026-08-11

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
Baseline, Week 24

What was measured

Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in subjects with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. Analysis was performed on ITT population.

Analysis population: All randomized participants

Groups in this outcome

Placebo

Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.

SAR302503 400 mg

SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).

SAR302503 500 mg

SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).

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

Analysis denominator · Participants

GroupSource count
Placebo96
SAR302503 400 mg96
SAR302503 500 mg97

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo2.1004.9Not reported
SAR302503 400 mg49393959Not reported
SAR302503 500 mg51.541.641.661.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        spread
        0
        upper Limit
        4.9
        value
        2.1
      2. group Id
        OG001
        lower Limit
        39
        spread
        39
        upper Limit
        59
        value
        49
      3. group Id
        OG002
        lower Limit
        41.6
        spread
        41.6
        upper Limit
        61.5
        value
        51.5
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    3. group Id
      OG002
      value
      97
    units
    Participants
description
Spleen volume was determined by magnetic resonance imaging (MRI) (or computed tomography scan in subjects with contraindications for MRI) at baseline and at the end of cycle 6 with a confirmatory scan approximately 4 weeks after the end of Cycle 6. Analysis was performed on ITT population.
dispersion Type
95% Confidence Interval
groups
  1. description
    Placebo up to 6 cycles (1 cycle=28 days - median exposure= 24 weeks). At the end of cycle 6, participants were crossed-over to SAR302503 400 or 500 mg until disease progression or unacceptable toxicity.
    id
    OG000
    title
    Placebo
  2. description
    SAR302503 400 mg until disease progression and/or unacceptable toxicity (median exposure= 62.1 weeks).
    id
    OG001
    title
    SAR302503 400 mg
  3. description
    SAR302503 500 mg until disease progression and/or unacceptable toxicity (median exposure =59.7 weeks).
    id
    OG002
    title
    SAR302503 500 mg
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
Baseline, Week 24
title
Percentage of Participants Who Had >=25% Reduction From Baseline in Volume of Spleen Size at End of Cycle 6
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Independent clinical review pending · Not medical advice