NCT01243944 · OUTCOME

The Percentage of Participants Achieving a Durable Complete or Partial Clinicohematologic Response 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: Not reported
Time frame: 48 Weeks

What was measured

Durable Complete or Partial Clinicohematologic Response was defined as any participant who achieved complete or partial clinicohematologic response per the European LeukemiaNet modified criteria for response in polycythemia vera 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

Group	Source count
Ruxolitinib	110
Best Available Therapy	112

Reported measurements

Complete response rate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	7.3	Not reported	Not reported	Not reported	Not reported
Best Available Therapy	0.9	Not reported	Not reported	Not reported	Not reported

Partial response rate

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	50.9	Not reported	Not reported	Not reported	Not reported
Best Available Therapy	0.9	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7.3
group Id
OG001
value
0.9
title
Complete response rate
categories
measurements
group Id
OG000
value
50.9
group Id
OG001
value
0.9
title
Partial response rate

denoms

counts
group Id
OG000
value
110
group Id
OG001
value
112
units
Participants

description

groups

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
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 Achieving a Durable Complete or Partial Clinicohematologic Response 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