Comparison · NCT00824265-9069bf7c
Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects vs Fludarabine + Cyclophosphamide_ ITT Subjects: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)
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: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA). Trial comparisons, record NCT00824265-9069bf7c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00824265-9069bf7c
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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 | 0.0166 | 0.00565 | 0.0476 | wilson | |
| Risk in group 2 | 0.0112 | 0.00309 | 0.04 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00534 | -0.0255 | 0.0374 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.48 | 0.249 | 8.72 | log | |
| Odds ratio, group 1 over group 2 | 1.48 | 0.245 | 8.98 | log | |
| Number needed to treat, for one more participant with the outcome on Ofatumumab + Fludarabine + Cyclophosphamide_ ITT Subjects than on Fludarabine + Cyclophosphamide_ ITT Subjects | 187 | 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 | 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. | 3 | 181 | OG000 |
| 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. | 2 | 178 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Autoimmune Hemolytic Anaemia (AIHA)
- Description
- AIHA is a condition where the body's immune system fails to recognize red blood cells as self and begins destroying these red blood cells. The number of participants experienced AIHA are presented.
- Time frame
From first dose of study medication to 60 days after the last dose of study medication (for an AE), or up to 5 years after the last dose of study drug or until the time of the next anti-CLL therapy (for SAE)
- Population
- Safety Population
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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