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NCT02038036 · OUTCOME

Summary of Patient Global Impression of Change (PGIC), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover

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
Baseline (last assessment before cross over), Week 4, 8, 16, 24, 28, 40, and 52 after cross-over

What was measured

The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.

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

Best Available Therapy (BAT)

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
Best Available Therapy (BAT)58

Reported measurements

Week +4

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)52

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)10Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)13Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)13Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)16Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +8

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)53

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)11Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)25Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)9Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)7Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)1Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +16

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)52

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)12Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)28Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +24

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)50

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)19Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)17Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)8Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)1Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +28

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)50

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)18Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)19Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)1Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +40

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)44

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)18Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)15Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)5Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Week +52

Analysis denominator · Participants

GroupSource count
Best Available Therapy (BAT)42

Very much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)17Not reportedNot reportedNot reportedNot reported

Much improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)16Not reportedNot reportedNot reportedNot reported

Minimally improved

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)6Not reportedNot reportedNot reportedNot reported

No change

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)3Not reportedNot reportedNot reportedNot reported

Minimally worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported

Much worse

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Best Available Therapy (BAT)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        13
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        13
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        16
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        25
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        9
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        7
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        53
      units
      Participants
    title
    Week +8
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        28
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        52
      units
      Participants
    title
    Week +16
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        17
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        8
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +24
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        19
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        50
      units
      Participants
    title
    Week +28
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        15
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        5
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        6
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Week +40
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      title
      Very much improved
    2. measurements
      1. group Id
        OG000
        value
        16
      title
      Much improved
    3. measurements
      1. group Id
        OG000
        value
        6
      title
      Minimally improved
    4. measurements
      1. group Id
        OG000
        value
        3
      title
      No change
    5. measurements
      1. group Id
        OG000
        value
        0
      title
      Minimally worse
    6. measurements
      1. group Id
        OG000
        value
        0
      title
      Much worse
    denoms
    1. counts
      1. group Id
        OG000
        value
        42
      units
      Participants
    title
    Week +52
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    units
    Participants
description
The Patient Global Impression of Change (PGIC) is comprised of a single question intended to measure a patient's perspective of improvement or deterioration over time relative to treatment. The PGIC uses a seven-point scale where one (1) equals very much improved and seven (7) equals very much worse.
groups
  1. description
    Participants randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib
    id
    OG000
    title
    Best Available Therapy (BAT)
param Type
COUNT_OF_PARTICIPANTS
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, 16, 24, 28, 40, and 52 after cross-over
title
Summary of Patient Global Impression of Change (PGIC), by Visit in Patients From BAT Group Who Cross Over to Ruxolitinib After Crossover
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice