Comparison · NCT03364231-114c0e18
MZL: Umbralisib vs WM: Umbralisib: Number of Participants With at Least One Adverse Event (AE)
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. MZL: Umbralisib vs WM: Umbralisib: Number of Participants With at Least One Adverse Event (AE). Trial comparisons, record NCT03364231-114c0e18. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03364231-114c0e18
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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 | 1 | 0.676 | 1 | wilson | |
| Risk in group 2 | 1 | 0.772 | 1 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.324 | 0.228 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 1 | 1 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | MZL: Umbralisib | Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity or withdrawal from the study whichever occurred first. | 8 | 8 | OG000 |
| Group 2 | WM: Umbralisib | Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first. | 13 | 13 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With at Least One Adverse Event (AE)
- Description
An AE is any untoward medical occurrence in a participant that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
- Time frame
- From first dose of study treatment up to end of study (up to approximately 4.2 years)
- Population
- Safety population included all enrolled participants who received at least one dose of study treatment.
Source ClinicalTrials.gov
Trial
- Title
- Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
- NCT number
- NCT03364231
- Phases
- PHASE2
- Conditions
- Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma
- Interventions
- Umbralisib
- Lead sponsor
- TG Therapeutics, Inc.
- Results first posted
- 2023-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03364231?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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