Comparison · NCT00577993-sae
Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): 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. Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab vs Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND): serious adverse events. Trial comparisons, record NCT00577993-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00577993-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 | 0.859 | 0.765 | 0.919 | wilson | |
| Risk in group 2 | 0.963 | 0.895 | 0.987 | wilson | |
| Risk difference, group 1 minus group 2 | -0.104 | -0.201 | -0.0133 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.892 | 0.808 | 0.986 | log | |
| Odds ratio, group 1 over group 2 | 0.237 | 0.0635 | 0.887 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab than on Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | 9.66 | 4.98 | 75.3 | from the risk difference interval |
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 | Fludarabine,Mitoxantrone, and Dexamethasone (FND)-Rituximab | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with follow-up Ritux,Flidara,Mitoxan,Dex | 67 | 78 | EG000 |
| Group 2 | Rituximab- Fludarabine,Mitoxantrone, and Dexamethasone (FND) | Fludarabine,Mitoxantrone, and Dexamethasone (FND) with concurrent Ritux,Flidara,Mitoxan,Dex. | 77 | 80 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 10 years
Source ClinicalTrials.gov
Trial
- Title
- Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients
- NCT number
- NCT00577993
- Phases
- PHASE3
- Conditions
- Lymphoma
- Interventions
- Fludarabine, Novantrone, Decadron, Rituximab, Interferon, Doxorubicin, Vincristine, Bleomycin, Cyclophosphamide, Etoposide, Cisplatin, Ara-C, Methyl-Prednisolone, Procarbazine, Prednisone
- Lead sponsor
- M.D. Anderson Cancer Center
- Results first posted
- 2020-11-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00577993?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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