Comparison · NCT04551066-sae
Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: 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. Parsaclisib Plus Ruxolitinib vs Placebo Plus Ruxolitinib: serious adverse events. Trial comparisons, record NCT04551066-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04551066-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 | 0.208 | 0.146 | 0.287 | wilson | |
| Risk in group 2 | 0.142 | 0.0916 | 0.213 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0663 | -0.0281 | 0.16 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.848 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 1.59 | 0.822 | 3.08 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Parsaclisib Plus Ruxolitinib than on Placebo Plus Ruxolitinib | 15.1 | 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 | Parsaclisib Plus Ruxolitinib | Participants were randomized to receive parsaclisib plus ruxolitinib beginning on Day 1 and continued on this regimen as long as it was tolerated and the participants did not meet any discontinuation criteria. Participants with a Baseline platelet count ≥100 × 10\^9/Liter received ruxolitinib 15 milligrams (mg) twice daily (BID). Participants with a Baseline platelet count of 50 to \< 100 × 10\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the Dynamic International Prognostic Scoring System (DIPSS) risk category (high versus intermediate-2 versus intermediate-1). Participants received parsaclisib at a dose of 5 mg once daily (QD). | 26 | 125 | EG000 |
| Group 2 | Placebo Plus Ruxolitinib | Participants were randomized to receive placebo plus ruxolitinib beginning on Day 1 and continued on this regimen until they left the study. Participants with a Baseline platelet count ≥100 × 10\^9/Liter received ruxolitinib 15 mg BID. Participants with a Baseline platelet count of 50 to \< 100 × 10\^9/Liters inclusive received ruxolitinib 5 mg BID. Participants were also stratified according to the DIPSS risk category (high versus intermediate-2 versus intermediate-1). Participants received matching placebo at a dose of 5 mg QD. After 24 weeks, participants randomized to receive placebo plus ruxolitinib could have switched to treatment with parsaclisib plus ruxolitinib per the regimen received during the first 24 weeks of the study. Treatment continued for as long as the regimen was tolerated and the participant did not meet any discontinuation criteria. | 18 | 127 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to 960 days
Source ClinicalTrials.gov
Trial
- Title
- To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
- NCT number
- NCT04551066
- Phases
- PHASE3
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
- Interventions
- parsaclisib, ruxolitinib, placebo
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2024-10-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04551066?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/NCT04551066-sae