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NCT02038036 · OUTCOME

Number of Participants Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria 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 who achieved partial remission at Week 104, based on the ELN and IWG-MRT criteria, as defined by: * MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 104, and * Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8, and * WBC \< 10 x10\^9/L at Week 104, and * Platelets ≤ 400 x 10\^9/L at Week 104, and * No palpable spleen at Week 104, and * No hemorrhagic or thrombotic events, and * No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria) Endpoint for Week 156, Week 208 and Week 260 are 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
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib4Not reportedNot reportedNot reportedNot reported
Week 156
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib9Not reportedNot reportedNot reportedNot reported
Week 208
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib4Not reportedNot reportedNot reportedNot reported
Week 260
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Week 104
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Week 156
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Week 208
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Week 260
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
Proportion of patients who achieved partial remission at Week 104, based on the ELN and IWG-MRT criteria, as defined by: * MPN-SAF TSS score reduction of greater than or equal to 10 points from baseline to Week 104, and * Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 104, with no more than one phlebotomy eligibility occurring post-randomization and prior to Week 8, and * WBC \< 10 x10\^9/L at Week 104, and * Platelets ≤ 400 x 10\^9/L at Week 104, and * No palpable spleen at Week 104, and * No hemorrhagic or thrombotic events, and * No transformation into post-PV myelofibrosis, myelodysplastic syndrome (IWG-MRT criteria) or acute leukemia (WHO criteria) Endpoint for Week 156, Week 208 and Week 260 are 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 Who Achieved Partial Remission Based on the European Leukemia Net (ELN) and International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) Criteria 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