Comparison · NCT00748189-795ec87d
Chlorambucil vs Ofatumumab + Chlorambucil: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease
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. Chlorambucil vs Ofatumumab + Chlorambucil: Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease. Trial comparisons, record NCT00748189-795ec87d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00748189-795ec87d
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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 | 0.0264 | 0.0122 | 0.0565 | wilson | |
| Risk in group 2 | 0.0184 | 0.00719 | 0.0464 | wilson | |
| Risk difference, group 1 minus group 2 | 0.008 | -0.0234 | 0.0401 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.43 | 0.41 | 5.01 | log | |
| Odds ratio, group 1 over group 2 | 1.45 | 0.402 | 5.19 | log | |
| Number needed to treat, for one more participant with the outcome on Chlorambucil than on Ofatumumab + Chlorambucil | 125 | 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 | Chlorambucil | Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil monotherapy 10 milligram (mg)/meter squared (m\^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. | 6 | 227 | OG000 |
| Group 2 | Ofatumumab + Chlorambucil | Participants with CLL received intravenous (IV) infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by IV infusions of 1000 mg on the first day of each subsequent 28-day cycle in combination with chlorambucil 10 mg/m\^2 orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. | 4 | 217 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Autoimmune Hemolytic Anaemia (AIHA) Disease
- Description
- AIHA is a disease 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 diagnosed with AIHA are presented.
- Time frame
From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy, up to approximately 111 months.
- Population
- Safety Population
Source ClinicalTrials.gov
Trial
- Title
- Ofatumumab + Chlorambucil vs Chlorambucil Monotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT00748189
- Phases
- PHASE3
- Conditions
- Leukaemia, Lymphocytic, Chronic
- Interventions
- chlorambucil, tablets, ofatumumab (GSK1841157) infusion
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2014-03-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00748189?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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