Comparison · NCT00824265-sae
Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: 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. Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: serious adverse events. Trial comparisons, record NCT00824265-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00824265-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 | 0.597 | 0.524 | 0.665 | wilson | |
| Risk in group 2 | 0.483 | 0.411 | 0.556 | wilson | |
| Risk difference, group 1 minus group 2 | 0.114 | 0.0105 | 0.213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.23 | 1.02 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 1.04 | 2.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects than on Fludarabine + Cyclophosphamide_ ITT Subjects | 8.81 | 4.69 | 95.4 | 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 | Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects | Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared \[m\^2\] and cyclophosphamide was administered at 250mg/m\^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status. | 108 | 181 | EG000 |
| Group 2 | Fludarabine + Cyclophosphamide_ ITT Subjects | Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m\^2 and cyclophosphamide administered at 250mg/m\^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status. | 86 | 178 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Ofatumumab Added to Fludarabine-Cyclophosphamide vs Fludarabine-Cyclophosphamide Combination in Relapsed Subjects With Chronic Lymphocytic Leukemia
- NCT number
- NCT00824265
- Phases
- PHASE3
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- OFC Infusion, FC infusion
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2016-07-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00824265?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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