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NCT01243944 · OUTCOME

Duration of The Overall Clinicohematologic 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
256 Weeks

What was measured

Duration of the overall clinicohematologic response was defined as the time from the first occurrence of complete response (CR) or partial response (PR) until the date of the first documented disease progression.

Analysis population: Full Analysis Set (FAS) comprises all participants to whom study treatment had been assigned by randomization. Duration of the overall clinicohematologic 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
Ruxolitinib0.99Not reported0.901.00Not reported
48 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.96Not reported0.870.99Not reported
64 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.91Not reported0.810.96Not reported
80 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.88Not reported0.780.94Not reported
96 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.88Not reported0.780.94Not reported
112 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.85Not reported0.740.92Not reported
128 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.82Not reported0.710.89Not reported
144 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.82Not reported0.710.89Not reported
160 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.80Not reported0.690.88Not reported
176 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.75Not reported0.630.84Not reported
192 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.70Not reported0.570.80Not reported
208 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.67Not reported0.540.77Not reported
224 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.67Not reported0.540.77Not reported
240 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.67Not reported0.540.77Not reported
256 weeks
Values in probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ruxolitinib0.67Not reported0.540.77Not reported
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. group Id
        OG000
        lower Limit
        0.90
        upper Limit
        1.00
        value
        0.99
    title
    32 weeks
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.87
        upper Limit
        0.99
        value
        0.96
    title
    48 weeks
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.81
        upper Limit
        0.96
        value
        0.91
    title
    64 weeks
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.78
        upper Limit
        0.94
        value
        0.88
    title
    80 weeks
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.78
        upper Limit
        0.94
        value
        0.88
    title
    96 weeks
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.74
        upper Limit
        0.92
        value
        0.85
    title
    112 weeks
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.71
        upper Limit
        0.89
        value
        0.82
    title
    128 weeks
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.71
        upper Limit
        0.89
        value
        0.82
    title
    144 weeks
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.69
        upper Limit
        0.88
        value
        0.80
    title
    160 weeks
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.63
        upper Limit
        0.84
        value
        0.75
    title
    176 weeks
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.57
        upper Limit
        0.80
        value
        0.70
    title
    192 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      110
    units
    Participants
description
Duration of the overall clinicohematologic response was defined as the time from the first occurrence of complete response (CR) or partial response (PR) until the date of the first documented disease progression.
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 the overall clinicohematologic 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
256 Weeks
title
Duration of The Overall Clinicohematologic Response
type
SECONDARY
unit Of Measure
probability

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

Preserved source evidence · Not medical advice