Comparison · NCT00137969-sae
Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: 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 1000 mg + Prednisone vs Placebo + Prednisone: serious adverse events. Trial comparisons, record NCT00137969-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00137969-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 | 0.426 | 0.354 | 0.501 | wilson | |
| Risk in group 2 | 0.364 | 0.271 | 0.468 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0624 | -0.0644 | 0.182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.17 | 0.845 | 1.62 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 0.764 | 2.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rituximab 1000 mg + Prednisone than on Placebo + Prednisone | 16 | 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 1000 mg + Prednisone | Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. | 72 | 169 | EG000 |
| Group 2 | Placebo + Prednisone | Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. | 32 | 88 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From the beginning to the end of the study (Week 78 plus extended safety follow-up, with an average duration of 96 weeks).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
- NCT number
- NCT00137969
- Phases
- PHASE2, PHASE3
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Rituximab, Placebo, Prednisone, Acetaminophen, Diphenhydramine
- Lead sponsor
- Genentech, Inc.
- Results first posted
- 2010-12-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00137969?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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