Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01243944 · OUTCOME

The Percentage of Participants Who Achieved Durable Spleen Volume Reduction at Week 48

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) · Source last updated 2019-03-06

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
48 Weeks

What was measured

Durable Spleen Volume Reduction was defined as a participant who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.

Analysis population: Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.

Groups in this outcome

Ruxolitinib

Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy

Best Available Therapy

Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

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

Analysis denominator · Participants

GroupSource count
Ruxolitinib110
Best Available Therapy112

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib37.3Not reported28.247.0Not reported
Best Available Therapy0.9Not reported0.04.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.2
        upper Limit
        47.0
        value
        37.3
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        4.9
        value
        0.9
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      112
    units
    Participants
description
Durable Spleen Volume Reduction was defined as a participant who achieved at least 35% reduction from baseline in spleen volume at Week 32 and maintained that response 48 weeks after randomization.
dispersion Type
95% Confidence Interval
groups
  1. description
    Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
    id
    OG000
    title
    Ruxolitinib
  2. description
    Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
    id
    OG001
    title
    Best Available Therapy
param Type
NUMBER
population Description
Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization.
reporting Status
POSTED
time Frame
48 Weeks
title
The Percentage of Participants Who Achieved Durable Spleen Volume Reduction at Week 48
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice