NCT01243944 · OUTCOME

The Percentage of Participants Achieving a Durable Primary 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: 95% Confidence Interval
Time frame: 48 Weeks

What was measured

Durable Primary Response was defined as any participant who achieved the primary outcome measure and who maintained their response up to 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

Source class 1

Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Ruxolitinib	20.0	Not reported	13.0	28.7	Not reported
Best Available Therapy	0.9	Not reported	0.0	4.9	Not reported

Source statistical analyses

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

ci Lower Limit
4.24
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1144
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
28.01
statistical Method
Exact Cochran-Mantel-Haenszel

Complete source fields

analyses

ci Lower Limit
4.24
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1144
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
<0.0001
param Type
Odds Ratio (OR)
param Value
28.01
statistical Method
Exact Cochran-Mantel-Haenszel

classes

categories
measurements
group Id
OG000
lower Limit
13.0
upper Limit
28.7
value
20.0
group Id
OG001
lower Limit
0.0
upper Limit
4.9
value
0.9

denoms

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

description

Durable Primary Response was defined as any participant who achieved the primary outcome measure and who maintained their response up to 48 weeks after randomization.

dispersion Type

95% Confidence Interval

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 Primary 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