Comparison · NCT04603495-sae
Pelabresib + Ruxolitinib (Experimental Arm) vs Placebo + Ruxolitinib (Control Arm): 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. Pelabresib + Ruxolitinib (Experimental Arm) vs Placebo + Ruxolitinib (Control Arm): serious adverse events. Trial comparisons, record NCT04603495-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04603495-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 | 0.297 | 0.24 | 0.362 | wilson | |
| Risk in group 2 | 0.294 | 0.237 | 0.359 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00278 | -0.0834 | 0.089 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.753 | 1.35 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.668 | 1.54 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Pelabresib + Ruxolitinib (Experimental Arm) than on Placebo + Ruxolitinib (Control Arm) | 360 | 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 | Pelabresib + Ruxolitinib (Experimental Arm) | Pelabresib 125 mg orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle | 63 | 212 | EG000 |
| Group 2 | Placebo + Ruxolitinib (Control Arm) | Matching placebo orally (PO) once daily (QD) + ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 14 consecutive days followed by ruxolitinib 10 or 15 mg orally (PO) twice a day (BID) for 7 days in a 21-day cycle | 63 | 214 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study treatment up to the cut-off date for the interim analysis (31-Aug-2023), approximately 28 months
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
- NCT number
- NCT04603495
- Phases
- PHASE3
- Conditions
- Myelofibrosis, Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Interventions
- Pelabresib, Ruxolitinib, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-10-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04603495?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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