Comparison · NCT01729455-sae
Benlysta vs Non-Benlysta: 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. Benlysta vs Non-Benlysta: serious adverse events. Trial comparisons, record NCT01729455-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01729455-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 | 0.129 | 0.115 | 0.145 | wilson | |
| Risk in group 2 | 0.123 | 0.103 | 0.146 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00631 | -0.021 | 0.0318 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.851 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.832 | 1.35 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Benlysta than on Non-Benlysta | 158 | 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 | Benlysta | Participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who were receiving or initiated Benlysta intravenously/subcutaneously along with standard of care (SoC) therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated Benlysta within 2 months prior to enrollment) or current users (receiving Benlysta for greater than or equal to \[\>=2\] months at enrollment) of Benlysta. | 248 | 1,924 | EG000 |
| Group 2 | Non-Benlysta | Participants with active, autoantibody-positive SLE who did not receive Benlysta but were receiving only SoC therapy at Baseline (Day 0) were included in this cohort. Participants could be treatment initiators (initiated SoC therapy within 2 months prior to enrollment) or current users (receiving SoC therapy for \>=2 months at enrollment) of SoC therapy. | 108 | 881 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment (Day 0) up to 63 Months
Source ClinicalTrials.gov
Trial
- Title
- Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry
- NCT number
- NCT01729455
- Phases
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Benlysta, Standard of Care (SoC) Therapy
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2026-03-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01729455?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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