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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 52 and Week 80

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
Week 52 and 80

What was measured

Proportion of patients who achieved partial remission at Week 52 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 52 and * Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x109/L at Week 52 and * Platelets ≤ 400 x 109/L at Week 52 and * No palpable spleen at Week 52 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 80 was 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.

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

Best Available Therapy (BAT)

Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib

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
Best Available Therapy (BAT)75

Reported measurements

Week 52
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib5Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week 80
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ruxolitinib4Not reportedNot reportedNot reportedNot reported
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        0
    title
    Week 52
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    Week 80
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      75
    units
    Participants
description
Proportion of patients who achieved partial remission at Week 52 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 52 and * Hct control defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 52 with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8, and * WBC \< 10 x109/L at Week 52 and * Platelets ≤ 400 x 109/L at Week 52 and * No palpable spleen at Week 52 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 80 was 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
  2. description
    Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib
    id
    OG001
    title
    Best Available Therapy (BAT)
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.
reporting Status
POSTED
time Frame
Week 52 and 80
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 52 and Week 80
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice