Comparison · NCT03538041-sae
Parsaclisib 1 mg QD vs Parsaclisib 2.5 mg QD: 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 1 mg QD vs Parsaclisib 2.5 mg QD: serious adverse events. Trial comparisons, record NCT03538041-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03538041-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 | 0.6 | 0.313 | 0.832 | wilson | |
| Risk in group 2 | 0.333 | 0.152 | 0.583 | wilson | |
| Risk difference, group 1 minus group 2 | 0.267 | -0.114 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.8 | 0.749 | 4.32 | log | |
| Odds ratio, group 1 over group 2 | 3 | 0.571 | 15.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Parsaclisib 1 mg QD than on Parsaclisib 2.5 mg QD | 3.75 | 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 1 mg QD | Participants received oral parsaclisib once daily (QD) for 12 weeks. Participants initially received parsaclisib 1 milligram (mg) QD. At Week 6, participants who continued to require transfusions or did not attain a meaningful clinical response (at least a stabilization of a ≥ 2 grams per deciliter \[g/dL\] increase in hemoglobin from Baseline to Week 6) may have had their dose increased, with sponsor preapproval, to parsaclisib 2.5 mg QD until Week 12. If there were any tolerability issues in individual participants who received 2.5 mg, the dose could have been decreased to 1 mg. Participants who continued to receive clinical benefit after the 12-week Treatment Period could have entered into an Extension Period, during which they, with sponsor approval, continued to receive parsaclisib 1 mg QD or 2.5 mg QD until the drug was available through another clinical study, or was commercially available, or the sponsor stopped the study or the study drug development. Following the last dose of parsaclisib, in either the Treatment Period (for participants not entering the Extension Period) or the Extension Period, participants were eligible for a 12-week (3-month) follow-up period. | 6 | 10 | EG000 |
| Group 2 | Parsaclisib 2.5 mg QD | Participants received oral parsaclisib 2.5 mg QD for 12 weeks. If there were any tolerability issues in individual participants, the dose could have been decreased to 1 mg. Participants who continued to receive clinical benefit after the 12-week Treatment Period could have entered into an Extension Period, during which they, with sponsor approval, continued to receive parsaclisib 2.5 mg QD until the drug was available through another clinical study, or was commercially available, or the sponsor stopped the study or the study drug development. Following the last dose of parsaclisib, in either the Treatment Period (for participants not entering the Extension Period) or the Extension Period, participants were eligible for a 12-week (3-month) follow-up period. | 5 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- up to a maximum of 1638 days
Source ClinicalTrials.gov
Trial
- Title
- A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
- NCT number
- NCT03538041
- Phases
- PHASE2
- Conditions
- Autoimmune Hemolytic Anemia
- Interventions
- Parsaclisib
- Lead sponsor
- Incyte Corporation
- Results first posted
- 2022-09-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03538041?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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