Comparison · NCT00104299-sae
Rituximab vs Control Group: 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 vs Control Group: serious adverse events. Trial comparisons, record NCT00104299-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00104299-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 | 0.606 | 0.508 | 0.697 | wilson | |
| Risk in group 2 | 0.48 | 0.383 | 0.577 | wilson | |
| Risk difference, group 1 minus group 2 | 0.126 | -0.0123 | 0.259 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.26 | 0.974 | 1.64 | log | |
| Odds ratio, group 1 over group 2 | 1.67 | 0.949 | 2.94 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rituximab than on Control Group | 7.91 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rituximab | Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information. | 60 | 99 | EG000 |
| Group 2 | Control Group | Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information. | 47 | 98 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Source ClinicalTrials.gov
Trial
- Title
- Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis
- NCT number
- NCT00104299
- Phases
- PHASE2, PHASE3
- Conditions
- Vasculitis, Wegener's Granulomatosis, Microscopic Polyangiitis
- Interventions
- Rituximab plus cyclophosphamide placebo (rituximab group), Cyclophosphamide plus rituximab placebo (control group), Azathioprine, Methylprednisolone (or other glucocorticoid), Prednisone
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Results first posted
- 2011-08-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00104299?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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