Comparison · NCT00952289-sae
Ruxolitinib vs Placebo: serious adverse events
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 Placebo: serious adverse events. Trial comparisons, record NCT00952289-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00952289-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 | 0.277 | 0.213 | 0.353 | wilson | |
| Risk in group 2 | 0.351 | 0.279 | 0.43 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0736 | -0.176 | 0.0303 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.79 | 0.566 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.71 | 0.437 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Ruxolitinib than on Placebo | 13.6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ruxolitinib | Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. | 43 | 155 | EG000 |
| Group 2 | Placebo | Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment. | 53 | 151 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization through data cut-off of the primary analysis (02 November 2010).
Source ClinicalTrials.gov
Trial
- Title
- COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
- NCT number
- NCT00952289
- Phases
- PHASE3
- Conditions
- MPN (Myeloproliferative Neoplasms)
- Interventions
- Ruxolitinib, Placebo
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2012-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00952289?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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