Comparison · NCT03078855-sae
Vitamin D Plus Rituximab vs Placebo Plus Rituximab: 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. Vitamin D Plus Rituximab vs Placebo Plus Rituximab: serious adverse events. Trial comparisons, record NCT03078855-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03078855-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 | 0.119 | 0.0743 | 0.184 | wilson | |
| Risk in group 2 | 0.127 | 0.0681 | 0.224 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00824 | -0.115 | 0.0795 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.935 | 0.435 | 2.01 | log | |
| Odds ratio, group 1 over group 2 | 0.926 | 0.387 | 2.22 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Vitamin D Plus Rituximab than on Placebo Plus Rituximab | 121 | 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 | Vitamin D Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and vitamin D3, 2000 IU, was taken orally once daily. Participants took vitamin D3 until lack of response at week 13, disease progression, or initiation of a new treatment. | 16 | 135 | EG000 |
| Group 2 | Placebo Plus Rituximab | Rituximab was administered weekly x 4 (intravenous 375 mg/m\^2 or subcutaneous equivalent) per institutional standards and placebo was taken orally once daily. Participants took placebo until lack of response at week 13, disease progression, or initiation of a new treatment. | 9 | 71 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events and serious adverse events were evaluated beginning on day 1 of treatment through 30 days after the last dose of vitamin D or placebo, up to 37 months. All-cause mortality was evaluated beginning on day 1 of treatment until study closure with a maximum follow-up of 64 months.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
- NCT number
- NCT03078855
- Phases
- PHASE3
- Conditions
- Follicular Lymphoma, Small Lymphocytic Lymphoma, Marginal Zone Lymphoma, Mucosal-Associated Lymphoid Tissue Lymphoma
- Interventions
- Vitamin D, Rituximab, Placebo
- Lead sponsor
- Jonathan Friedberg
- Results first posted
- 2024-09-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03078855?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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