Comparison · NCT01998880-sae
Rituximab + Chlorambucil (RClb) vs Chlorambucil (Clb): 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. Rituximab + Chlorambucil (RClb) vs Chlorambucil (Clb): serious adverse events. Trial comparisons, record NCT01998880-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01998880-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 | 0.387 | 0.325 | 0.452 | wilson | |
| Risk in group 2 | 0.388 | 0.304 | 0.479 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00126 | -0.111 | 0.105 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.997 | 0.752 | 1.32 | log | |
| Odds ratio, group 1 over group 2 | 0.995 | 0.628 | 1.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Rituximab + Chlorambucil (RClb) than on Chlorambucil (Clb) | 791 | 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 | Rituximab + Chlorambucil (RClb) | Participants received 375 mg/m\^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m\^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles). | 87 | 225 | EG000 |
| Group 2 | Chlorambucil (Clb) | Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil. | 45 | 116 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
- NCT number
- NCT01998880
- Phases
- PHASE3
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- obinutuzumab, rituximab, chlorambucil
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2014-01-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01998880?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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