Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02038036 · OUTCOME

Change From Baseline in Hematocrit (Hct) at Each Scheduled Visit After Crossover in Participants Randomized to BAT Who Cross Over to Ruxolitinib

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
MEAN
Unit
Volume percentage of RBC in blood
Interval / dispersion
Standard Deviation
Time frame
Baseline (last assessment before cross over), Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 64, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206, 219 and 232 after cross-over

What was measured

Hematocrit is the percentage of red blood cells (RBC) in the blood.

Analysis population: Cross-over set consisted of all participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.

Groups in this outcome

All Crossover Patients

Participants randomized to the BAT arm, who crossed over and received at least one dose of 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
All Crossover Patients58

Reported measurements

Week +4

Analysis denominator · Participants

GroupSource count
All Crossover Patients57
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-2.443.394Not reportedNot reportedNot reported
Week +8

Analysis denominator · Participants

GroupSource count
All Crossover Patients52
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-4.245.322Not reportedNot reportedNot reported
Week +12

Analysis denominator · Participants

GroupSource count
All Crossover Patients54
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-5.736.597Not reportedNot reportedNot reported
Week +16

Analysis denominator · Participants

GroupSource count
All Crossover Patients53
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.277.101Not reportedNot reportedNot reported
Week +20

Analysis denominator · Participants

GroupSource count
All Crossover Patients54
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-5.766.563Not reportedNot reportedNot reported
Week +24

Analysis denominator · Participants

GroupSource count
All Crossover Patients52
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-5.296.518Not reportedNot reportedNot reported
Week +28

Analysis denominator · Participants

GroupSource count
All Crossover Patients51
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.045.825Not reportedNot reportedNot reported
Week +40

Analysis denominator · Participants

GroupSource count
All Crossover Patients53
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.066.301Not reportedNot reportedNot reported
Week +52

Analysis denominator · Participants

GroupSource count
All Crossover Patients49
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-5.916.399Not reportedNot reportedNot reported
Week +64

Analysis denominator · Participants

GroupSource count
All Crossover Patients50
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.066.051Not reportedNot reportedNot reported
Week +76

Analysis denominator · Participants

GroupSource count
All Crossover Patients48
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.166.247Not reportedNot reportedNot reported
Week +89

Analysis denominator · Participants

GroupSource count
All Crossover Patients48
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.796.046Not reportedNot reportedNot reported
Week +102

Analysis denominator · Participants

GroupSource count
All Crossover Patients47
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.216.599Not reportedNot reportedNot reported
Week +115

Analysis denominator · Participants

GroupSource count
All Crossover Patients48
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.046.103Not reportedNot reportedNot reported
Week +128

Analysis denominator · Participants

GroupSource count
All Crossover Patients46
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.416.812Not reportedNot reportedNot reported
Week +141

Analysis denominator · Participants

GroupSource count
All Crossover Patients41
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.006.310Not reportedNot reportedNot reported
Week +154

Analysis denominator · Participants

GroupSource count
All Crossover Patients30
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.067.000Not reportedNot reportedNot reported
Week +167

Analysis denominator · Participants

GroupSource count
All Crossover Patients29
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.447.426Not reportedNot reportedNot reported
Week +180

Analysis denominator · Participants

GroupSource count
All Crossover Patients37
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.517.298Not reportedNot reportedNot reported
Week +193

Analysis denominator · Participants

GroupSource count
All Crossover Patients38
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.165.331Not reportedNot reportedNot reported
Week +206

Analysis denominator · Participants

GroupSource count
All Crossover Patients39
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.095.742Not reportedNot reportedNot reported
Week +219

Analysis denominator · Participants

GroupSource count
All Crossover Patients35
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-6.955.936Not reportedNot reportedNot reported
Week +232

Analysis denominator · Participants

GroupSource count
All Crossover Patients33
Values in Volume percentage of RBC in blood · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Crossover Patients-7.515.880Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.394
        value
        -2.44
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Week +4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.322
        value
        -4.24
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +8
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.597
        value
        -5.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Week +12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.101
        value
        -6.27
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Week +16
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.563
        value
        -5.76
    denoms
    1. counts
      1. group Id
        OG000
        value
        54
      units
      Participants
    title
    Week +20
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.518
        value
        -5.29
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.825
        value
        -6.04
    denoms
    1. counts
      1. group Id
        OG000
        value
        51
      units
      Participants
    title
    Week +28
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.301
        value
        -6.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Week +40
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.399
        value
        -5.91
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      units
      Participants
    title
    Week +52
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.051
        value
        -7.06
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +64
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.247
        value
        -6.16
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    Week +76
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.046
        value
        -6.79
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      units
      Participants
    title
    Week +89
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
Hematocrit is the percentage of red blood cells (RBC) in the blood.
dispersion Type
Standard Deviation
groups
  1. description
    Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
    id
    OG000
    title
    All Crossover Patients
param Type
MEAN
population Description
Cross-over set consisted of all participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.
reporting Status
POSTED
time Frame
Baseline (last assessment before cross over), Week 4, 8, 12, 16, 20, 24, 28, 40, 52, 64, 76, 89, 102, 115, 128, 141, 154, 167, 180, 193, 206, 219 and 232 after cross-over
title
Change From Baseline in Hematocrit (Hct) at Each Scheduled Visit After Crossover in Participants Randomized to BAT Who Cross Over to Ruxolitinib
type
SECONDARY
unit Of Measure
Volume percentage of RBC in blood

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

Preserved source evidence · Not medical advice