Comparison · NCT04221477-sae
Obinutuzumab vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Obinutuzumab vs Placebo: serious adverse events. Trial comparisons, record NCT04221477-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04221477-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 | 0.324 | 0.251 | 0.406 | wilson | |
| Risk in group 2 | 0.182 | 0.125 | 0.256 | wilson | |
| Risk difference, group 1 minus group 2 | 0.142 | 0.0375 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.78 | 1.15 | 2.75 | log | |
| Odds ratio, group 1 over group 2 | 2.15 | 1.22 | 3.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Obinutuzumab than on Placebo | 7.06 | 4.14 | 26.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Obinutuzumab | Participants received obinutuzumab, 1000 mg as an IV infusion on Day 1 and Weeks 2, 24, 26, and either Weeks 50 and 52 or Week 52 only, along with MMF and SOC therapy. Placebo was administered at Week 50 for participants not treated with obinutuzumab. Participants with adequate response at Week 76 continued to receive obinutuzumab at Week 80 and Q6M thereafter. The dose of MMF can be adjusted at the investigator's discretion beginning at Week 80. | 44 | 136 | EG000 |
| Group 2 | Placebo | Participants received Obinutuzumab matching placebo as an IV infusion on Day 1 and Weeks 2, 24, 26, 50, and 52. Participants also received SOC therapy and MMF. Participants with adequate response at Week 76 continued to receive placebo at Week 80 and Q6M thereafter. | 24 | 132 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Up to Week 76 Data collected up to the primary completion date (Up to Week 76) is reported. Data collection post Week 76 is still ongoing. Final data will be reported 1 year after the study completion date. As pre-specified in the SAP, safety data were to be provided for obinutuzumab (combined treatment groups) and placebo groups. AE data were collected for all Obinutuzumab participants together, without regard to or information of the specific Obinutuzumab group participants they were part of.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis
- NCT number
- NCT04221477
- Phases
- PHASE3
- Conditions
- Lupus Nephritis
- Interventions
- Obinutuzumab, MMF, Prednisone, Placebo, Methylprednisolone, Acetaminophen, Diphenhydramine
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2025-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04221477?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
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GET https://conductscience.org/api/comparisons/v1/NCT04221477-sae