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NCT01243944 · OUTCOME

The Percentage of Participants Who Achieved Overall Clinicohematologic Response at Week 32

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
Not reported
Time frame
32 Weeks

What was measured

Overall Clinicohematologic Response is defined as any participant who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.

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

Complete response rate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib8.2Not reportedNot reportedNot reportedNot reported
Best Available Therapy0.9Not reportedNot reportedNot reportedNot reported
Partial response rate
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib54.5Not reportedNot reportedNot reportedNot reported
Best Available Therapy18.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8.2
      2. group Id
        OG001
        value
        0.9
    title
    Complete response rate
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        54.5
      2. group Id
        OG001
        value
        18.8
    title
    Partial response rate
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    2. group Id
      OG001
      value
      112
    units
    Participants
description
Overall Clinicohematologic Response is defined as any participant who achieved a complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera (PV). A Complete Response (CR) is defined as: hematocrit control, spleen volume reduction at least 35% from baseline, platelet count less than or equal to 400 x 10(9)/L, and white blood cell count less than or equal to 10 x 10(9)/L. A Partial Response (PR) is defined as hematocrit control or response in all 3 of the other criteria.
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
32 Weeks
title
The Percentage of Participants Who Achieved Overall Clinicohematologic Response at Week 32
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice