NCT02038036 · OUTCOME
Patient Global Impression of Change (PGIC)
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 4, 8, 16, 28, 40, 52 and 80
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: 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 are reported as separate 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
| Group | Source count |
|---|
| Ruxolitinib | 74 |
|---|
| Best Available Therapy (BAT) | 75 |
|---|
Reported measurements
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 68 |
|---|
| Best Available Therapy (BAT) | 72 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 69 |
|---|
| Best Available Therapy (BAT) | 70 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 16
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 66 |
|---|
| Best Available Therapy (BAT) | 69 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 28
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 66 |
|---|
| Best Available Therapy (BAT) | 27 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 40
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 66 |
|---|
| Best Available Therapy (BAT) | 19 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 52
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 70 |
|---|
| Best Available Therapy (BAT) | 14 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 66
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 67 |
|---|
| Best Available Therapy (BAT) | 5 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 80
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 68 |
|---|
| Best Available Therapy (BAT) | 0 |
|---|
Very much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally improved
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
No change
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Minimally worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Very much worse
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 0
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 8
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 7
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 50
- title
- No change
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 72
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 1
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 14
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 9
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 35
- title
- No change
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 10
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 70
- units
- Participants
- title
- Week 8
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 2
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 13
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 33
- title
- No change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 5
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 69
- units
- Participants
- title
- Week 16
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 0
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 4
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 5
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 15
- title
- No change
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 27
- units
- Participants
- title
- Week 28
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 0
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 7
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 10
- title
- No change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 66
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Week 40
- categories
- measurements
- group Id
- OG000
- value
- 27
- group Id
- OG001
- value
- 2
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 5
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 1
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- title
- No change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 14
- units
- Participants
- title
- Week 52
- categories
- measurements
- group Id
- OG000
- value
- 23
- group Id
- OG001
- value
- 1
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 1
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 0
- title
- No change
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 67
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Week 66
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 0
- title
- Very much improved
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 0
- title
- Much improved
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 0
- title
- Minimally improved
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 0
- title
- No change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Minimally worse
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Much worse
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- Very much worse
- denoms
- counts
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Week 80
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 75
- 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
- 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
- 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. Data after crossover for participants randomized to BAT are reported as separate outcome measure.
- reporting Status
- POSTED
- time Frame
- Week 4, 8, 16, 28, 40, 52 and 80
- title
- Patient Global Impression of Change (PGIC)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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