Comparison · NCT00308087-sae
Rituximab vs Rituximab + Sargramostim: 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. Rituximab vs Rituximab + Sargramostim: serious adverse events. Trial comparisons, record NCT00308087-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00308087-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 | 0.135 | 0.0591 | 0.28 | wilson | |
| Risk in group 2 | 0.184 | 0.0922 | 0.334 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0491 | -0.217 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.734 | 0.256 | 2.11 | log | |
| Odds ratio, group 1 over group 2 | 0.692 | 0.198 | 2.41 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rituximab than on Rituximab + Sargramostim | 20.4 | 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 | Rituximab | Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks | 5 | 37 | EG000 |
| Group 2 | Rituximab + Sargramostim | Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks. | 7 | 38 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 24 months
Source ClinicalTrials.gov
Trial
- Title
- Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
- NCT number
- NCT00308087
- Phases
- PHASE2
- Conditions
- Lymphoma, Follicular
- Interventions
- Sargramostim (Leukine), Rituximab
- Lead sponsor
- Genzyme, a Sanofi Company
- Results first posted
- 2010-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00308087?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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