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NCT02038036 · OUTCOME

Number of Participants Achieving a Hematocrit (Hct) Control at Week 104, Week 156, Week 208 and Week 260.

Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From Week 8 to Week 104, 156, 208 and 260

What was measured

Proportion of patients achieving a Hct control at Week 104 as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104 and with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.

Analysis population: Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT were not collected.

Groups in this outcome

Ruxolitinib

Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Ruxolitinib74

Reported measurements

Week 104

Analysis denominator · Participants

GroupSource count
Ruxolitinib34

HU Resistant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib9Not reportedNot reportedNot reportedNot reported

HU Intolerant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib25Not reportedNot reportedNot reportedNot reported
Week 156

Analysis denominator · Participants

GroupSource count
Ruxolitinib30

HU Resistant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib9Not reportedNot reportedNot reportedNot reported

HU Intolerant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib21Not reportedNot reportedNot reportedNot reported
Week 208

Analysis denominator · Participants

GroupSource count
Ruxolitinib25

HU Resistant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib7Not reportedNot reportedNot reportedNot reported

HU Intolerant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib18Not reportedNot reportedNot reportedNot reported
Week 260

Analysis denominator · Participants

GroupSource count
Ruxolitinib16

HU Resistant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib4Not reportedNot reportedNot reportedNot reported

HU Intolerant

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib12Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      title
      HU Resistant
    2. measurements
      1. group Id
        OG000
        value
        25
      title
      HU Intolerant
    denoms
    1. counts
      1. group Id
        OG000
        value
        34
      units
      Participants
    title
    Week 104
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      title
      HU Resistant
    2. measurements
      1. group Id
        OG000
        value
        21
      title
      HU Intolerant
    denoms
    1. counts
      1. group Id
        OG000
        value
        30
      units
      Participants
    title
    Week 156
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      title
      HU Resistant
    2. measurements
      1. group Id
        OG000
        value
        18
      title
      HU Intolerant
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      units
      Participants
    title
    Week 208
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      title
      HU Resistant
    2. measurements
      1. group Id
        OG000
        value
        12
      title
      HU Intolerant
    denoms
    1. counts
      1. group Id
        OG000
        value
        16
      units
      Participants
    title
    Week 260
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
Proportion of patients achieving a Hct control at Week 104 as defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104 and with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8 Endpoint for Week 156, Week 208 and Week 260 were defined, similarly.
groups
  1. description
    Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid
    id
    OG000
    title
    Ruxolitinib
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure. Data after crossover for participants randomized to BAT were not collected.
reporting Status
POSTED
time Frame
From Week 8 to Week 104, 156, 208 and 260
title
Number of Participants Achieving a Hematocrit (Hct) Control at Week 104, Week 156, Week 208 and Week 260.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice