Comparison · NCT01712308-sae
Treatment Monotherapy (Sotatercept) vs Treatment Combination (Ruxolitinib + Sotatercept): 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. Treatment Monotherapy (Sotatercept) vs Treatment Combination (Ruxolitinib + Sotatercept): serious adverse events. Trial comparisons, record NCT01712308-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01712308-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 | 0.314 | 0.186 | 0.48 | wilson | |
| Risk in group 2 | 0.476 | 0.283 | 0.676 | wilson | |
| Risk difference, group 1 minus group 2 | -0.162 | -0.4 | 0.0922 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.66 | 0.34 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 0.504 | 0.165 | 1.54 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment Monotherapy (Sotatercept) than on Treatment Combination (Ruxolitinib + Sotatercept) | 6.18 | 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 | Treatment Monotherapy (Sotatercept) | Patients receive sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.~Sotatercept: Given SC | 11 | 35 | EG000 |
| Group 2 | Treatment Combination (Ruxolitinib + Sotatercept) | patients that are already on therapy with ruxolitinib (for at least for 6 months, and on stable dose for last 2 months) will continue ruxolitinib in addition to sotatercept SC once every 3 weeks. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients unable to achieve anemia-response after 8 cycles will be taken off study.~Sotatercept: Given SC~Ruxolitinib | 10 | 21 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 9 years
Source ClinicalTrials.gov
Trial
- Title
- Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia
- NCT number
- NCT01712308
- Phases
- PHASE2
- Conditions
- Anemia, Myelodysplastic/Myeloproliferative Neoplasm, Myelofibrosis
- Interventions
- Sotatercept, Ruxolitinib
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2023-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01712308?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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