Comparison · NCT01632904-sae
Ruxolitinib vs Hydroxyurea: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Ruxolitinib vs Hydroxyurea: serious adverse events. Trial comparisons, record NCT01632904-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01632904-sae
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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 | 0.0926 | 0.0402 | 0.199 | wilson | |
| Risk in group 2 | 0.0714 | 0.0281 | 0.17 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0212 | -0.0902 | 0.136 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.368 | 4.57 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.337 | 5.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ruxolitinib than on Hydroxyurea | 47.3 | from the risk difference interval | the interval includes no difference |
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 will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently. | 5 | 54 | EG000 |
| Group 2 | Hydroxyurea | Hydroxyurea (HU) (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently. | 4 | 56 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The duration of the study up to Week 16. This time frame defines the blinded, comparative phase of the study where the majority of patients remained on their original randomized assignment and exposure between ruxolitinib and hydroxyurea was similar.
Source ClinicalTrials.gov
Trial
- Title
- Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
- NCT number
- NCT01632904
- Phases
- PHASE3
- Conditions
- Polycythemia Vera
- Interventions
- Ruxolitinib, Hydroxyurea (HU), HU-placebo, Ruxolitinib-placebo
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2015-04-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01632904?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01632904-sae