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NCT01243944 · OUTCOME

Estimated Duration of the Primary Response

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
probability
Interval / dispersion
95% Confidence Interval
Time frame
Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study

What was measured

Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response). Kaplan-Meier estimates are provided for duration of primary response.

Analysis population: Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.

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

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

Reported measurements

16 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib1.00Not reportedNANAA confidence interval cannot be estimated at this time-point because no one had lost response.
32 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib1.00Not reportedNANAA confidence interval cannot be estimated at this time-point because no one had lost response.
48 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.92Not reported0.720.98Not reported
64 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.92Not reported0.720.98Not reported
80 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.92Not reported0.720.98Not reported
96 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.88Not reported0.670.96Not reported
112 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.84Not reported0.620.94Not reported
128 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.84Not reported0.620.94Not reported
144 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.84Not reported0.620.94Not reported
160 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.79Not reported0.570.91Not reported
176 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.79Not reported0.570.91Not reported
192 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.74Not reported0.510.88Not reported
208 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.74Not reported0.510.88Not reported
224 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.74Not reported0.510.88Not reported
240 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RuxolitinibNANot reportedNANANo additional progression was experienced within population at week 240.
256 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
RuxolitinibNANot reportedNANANo additional progression was experienced within population at week 256.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        A confidence interval cannot be estimated at this time-point because no one had lost response.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        1.00
    title
    16 weeks
  2. categories
    1. measurements
      1. comment
        A confidence interval cannot be estimated at this time-point because no one had lost response.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        1.00
    title
    32 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        0.98
        value
        0.92
    title
    48 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        0.98
        value
        0.92
    title
    64 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.72
        upper Limit
        0.98
        value
        0.92
    title
    80 weeks
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.67
        upper Limit
        0.96
        value
        0.88
    title
    96 weeks
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.62
        upper Limit
        0.94
        value
        0.84
    title
    112 weeks
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.62
        upper Limit
        0.94
        value
        0.84
    title
    128 weeks
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.62
        upper Limit
        0.94
        value
        0.84
    title
    144 weeks
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.57
        upper Limit
        0.91
        value
        0.79
    title
    160 weeks
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.57
        upper Limit
        0.91
        value
        0.79
    title
    176 weeks
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.51
        upper Limit
        0.88
        value
        0.74
    title
    192 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Duration of the primary response is defined as the time from the first occurrence when both components of the primary endpoint are met until the date of the first documented disease progression (end of response). Kaplan-Meier estimates are provided for duration of primary response.
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
param Type
NUMBER
population Description
Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of response was pre-specified in the protocol to be analyzed for the ruxolitinib arm only considering the study design which allowed crossover for the BAT arm beginning at Week 32.
reporting Status
POSTED
time Frame
Through study completion, analysis was conducted when all participants had completed the Week 80 visit or discontinued the study
title
Estimated Duration of the Primary Response
type
SECONDARY
unit Of Measure
probability

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Preserved source evidence · Not medical advice