Comparison · NCT00910910-sae
Lenalidomide vs Chlorambucil: 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. Lenalidomide vs Chlorambucil: serious adverse events. Trial comparisons, record NCT00910910-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00910910-sae
On this page
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 | 0.661 | 0.596 | 0.72 | wilson | |
| Risk in group 2 | 0.404 | 0.341 | 0.469 | wilson | |
| Risk difference, group 1 minus group 2 | 0.257 | 0.165 | 0.343 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.64 | 1.36 | 1.97 | log | |
| Odds ratio, group 1 over group 2 | 2.88 | 1.96 | 4.23 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Lenalidomide than on Chlorambucil | 3.89 | 2.92 | 6.05 | 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 | Lenalidomide | For participants with normal renal function \[defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min\], 5 mg lenalidomide was administered by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to \< 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first. | 148 | 224 | EG000 |
| Group 2 | Chlorambucil | Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months | 90 | 223 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All AEs were recorded by the Investigator(s) from first dose of study drug to 30 days after the treatment discontinuation visit. The median treatment duration was 263 days for lenalidomide and 362 days for chlorambucil.
Source ClinicalTrials.gov
Trial
- Title
- Study Of The Effectiveness & Safety Of Lenalidomide Versus Chlorambucil As First Line Therapy For Elderly Patients With B-Cell CLL (The ORIGIN Trial)
- NCT number
- NCT00910910
- Phases
- PHASE3
- Conditions
- B-Cell Chronic Lymphocytic Leukemia
- Interventions
- Lenalidomide, Chlorambucil
- Lead sponsor
- Celgene
- Results first posted
- 2016-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00910910?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00910910-sae