Comparison · NCT01340651-sae
Ruxolitinib - Weeks 1-16 vs Ruxolitinib - After Week 16: 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 - Weeks 1-16 vs Ruxolitinib - After Week 16: serious adverse events. Trial comparisons, record NCT01340651-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01340651-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 | 0.146 | 0.0688 | 0.284 | wilson | |
| Risk in group 2 | 0.22 | 0.12 | 0.367 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0732 | -0.24 | 0.097 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.667 | 0.261 | 1.7 | log | |
| Odds ratio, group 1 over group 2 | 0.61 | 0.195 | 1.9 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ruxolitinib - Weeks 1-16 than on Ruxolitinib - After Week 16 | 13.7 | 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 - Weeks 1-16 | Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. | 6 | 41 | EG000 |
| Group 2 | Ruxolitinib - After Week 16 | At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition. | 9 | 41 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from Baseline through the end of the study
Source ClinicalTrials.gov
Trial
- Title
- Study of Ruxolitinib (INCB018424) Sustained Release Formulation in Myelofibrosis Patients
- NCT number
- NCT01340651
- Phases
- PHASE2
- Conditions
- Myelofibrosis
- Interventions
- Ruxolitinib
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2013-09-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01340651?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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