NCT02038036 · OUTCOME
Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Week 28
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 and Week 28
What was measured
The ECOG scale of performance status described the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
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
| Group | Source count |
|---|
| Ruxolitinib | 74 |
|---|
| Best Available Therapy (BAT) | 75 |
|---|
Reported measurements
Grade 0 at baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 53 |
|---|
| Best Available Therapy (BAT) | 56 |
|---|
0: Fully active, able to carry on all pre-disease performance without restriction
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ruxolitinib | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Best Available Therapy (BAT) | 17 | Not reported | Not reported | Not reported | Not reported |
|---|
1: Restricted in physically strenuous activity and able to carry out light or sedentary work
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 |
|---|
2: Ambulatory and capable of all self-care but unable to carry out any work activities
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 |
|---|
3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
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 |
|---|
4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
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 |
|---|
Missing
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) | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 1 at baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Ruxolitinib | 21 |
|---|
| Best Available Therapy (BAT) | 19 |
|---|
0: Fully active, able to carry on all pre-disease performance without restriction
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) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
1: Restricted in physically strenuous activity and able to carry out light or sedentary work
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) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
2: Ambulatory and capable of all self-care but unable to carry out any work activities
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 |
|---|
3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
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 |
|---|
4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
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 |
|---|
Missing
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) | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 17
- title
- 0: Fully active, able to carry on all pre-disease performance without restriction
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- title
- 1: Restricted in physically strenuous activity and able to carry out light or sedentary work
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 2: Ambulatory and capable of all self-care but unable to carry out any work activities
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 38
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 53
- group Id
- OG001
- value
- 56
- units
- Participants
- title
- Grade 0 at baseline
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 1
- title
- 0: Fully active, able to carry on all pre-disease performance without restriction
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 5
- title
- 1: Restricted in physically strenuous activity and able to carry out light or sedentary work
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- title
- 2: Ambulatory and capable of all self-care but unable to carry out any work activities
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 13
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- Grade 1 at baseline
- denoms
- counts
- group Id
- OG000
- value
- 74
- group Id
- OG001
- value
- 75
- units
- Participants
- description
- The ECOG scale of performance status described the level of functioning of participants in terms of their ability to care for themselves, daily activity, and physical ability. The ECOG performance was recorded as per ECOG performance status grades ranging from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead).
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 28
- title
- Change From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status to Week 28
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle