Comparison · NCT03151057-sae
Idelalisib 100mg vs Placebo Oral Tablet: 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. Idelalisib 100mg vs Placebo Oral Tablet: serious adverse events. Trial comparisons, record NCT03151057-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03151057-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 | 0.778 | 0.453 | 0.937 | wilson | |
| Risk in group 2 | 0.571 | 0.25 | 0.842 | wilson | |
| Risk difference, group 1 minus group 2 | 0.206 | -0.217 | 0.565 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.656 | 2.83 | log | |
| Odds ratio, group 1 over group 2 | 2.63 | 0.3 | 23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Idelalisib 100mg than on Placebo Oral Tablet | 4.85 | 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 | Idelalisib 100mg | Idelalisib is an orally-administered, selective inhibitor of Phosphoinositide 3 kinase (PI3K)-delta which has been shown to be extremely effective in inducing partial to complete responses in many B-cell derived malignancies.~intervention: 100mg Idelalisib twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant~Idelalisib 100 MG: 100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant. | 7 | 9 | EG000 |
| Group 2 | Placebo Oral Tablet | Placebo to be taken twice daily beginning +90(+/- 10) days after allo HSCT and continued through Day 270 post transplant~Placebo Oral Tablet: placebo | 4 | 7 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 17 months
Source ClinicalTrials.gov
Trial
- Title
- Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies
- NCT number
- NCT03151057
- Phases
- PHASE1
- Conditions
- B Cells-Tumors, B Cell Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, Large B-Cell Diffuse Lymphoma of Bone (Diagnosis)
- Interventions
- Idelalisib 100 MG, Placebo Oral Tablet
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Results first posted
- 2024-03-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03151057?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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