Comparison · NCT02038036-e9e92203
Ruxolitinib vs Best Available Therapy (BAT): Number of Participants Achieving Hematocrit (Hct) Control at Week 28
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Ruxolitinib vs Best Available Therapy (BAT): Number of Participants Achieving Hematocrit (Hct) Control at Week 28. Trial comparisons, record NCT02038036-e9e92203. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02038036-e9e92203
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.622 | 0.508 | 0.724 | wilson | |
| Risk in group 2 | 0.187 | 0.115 | 0.289 | wilson | |
| Risk difference, group 1 minus group 2 | 0.435 | 0.282 | 0.56 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.33 | 2.01 | 5.52 | log | |
| Odds ratio, group 1 over group 2 | 7.16 | 3.39 | 15.1 | log | |
| Number needed to treat, for one more participant with the outcome on Ruxolitinib than on Best Available Therapy (BAT) | 2.3 | 1.79 | 3.55 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 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 | 46 | 74 | OG000 |
| Group 2 | 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 | 14 | 75 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Achieving Hematocrit (Hct) Control at Week 28
- Description
Proportion of patients achieving Hct control at Week 28 was defined by the absence of phlebotomy eligibility starting at Week 8 and continuing through Week 28, with no more than one phlebotomy eligibility occurring post randomization and prior to Week 8.~Phlebotomy eligibility was defined by:~* Confirmed Hct \> 45% that is at least 3 percentage points higher than the Hct obtained at Baseline Or~* Confirmed Hct \> 48% The confirmation occurred 2 to 14 days subsequent to the initial observation.
- Time frame
- Week 28
- Population
- Full Analysis Set (FAS) included all participants to whom study treatment was assigned by randomization and had valid measurements for the outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy.
- NCT number
- NCT02038036
- Phases
- PHASE3
- Conditions
- Polycythemia Vera
- Interventions
- Best Available Therapy, Ruxolitinib
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02038036?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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