Comparison · NCT00090051-sae
Fludarabine+Cyclophosphamide (FC) vs Fludarabine+Cyclophosphamide+Rituximab (FCR): 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+Cyclophosphamide (FC) vs Fludarabine+Cyclophosphamide+Rituximab (FCR): serious adverse events. Trial comparisons, record NCT00090051-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00090051-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 | 0.485 | 0.427 | 0.544 | wilson | |
| Risk in group 2 | 0.504 | 0.445 | 0.562 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0184 | -0.101 | 0.0651 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.964 | 0.813 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.929 | 0.664 | 1.3 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fludarabine+Cyclophosphamide (FC) than on Fludarabine+Cyclophosphamide+Rituximab (FCR) | 54.5 | 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 | Fludarabine+Cyclophosphamide (FC) | Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles. | 132 | 272 | EG000 |
| Group 2 | Fludarabine+Cyclophosphamide+Rituximab (FCR) | Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3. | 138 | 274 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events were collected from study start to 28 days after treatment completion (Median observation time= 26 months). Serious Adverse Events were collected 1 year after treatment completion (Median observation time= 37 months).
Source ClinicalTrials.gov
Trial
- Title
- FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
- NCT number
- NCT00090051
- Phases
- PHASE3
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Rituximab, Fludarabine Phosphate, Cyclophosphamide
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2012-01-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00090051?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.
For software
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