Comparison · NCT01632241-7de0197d
Belimumab 10 mg/kg (DB Phase) vs Placebo (DB Phase): Number of Participants With Severe AEs [DB Phase]
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. Belimumab 10 mg/kg (DB Phase) vs Placebo (DB Phase): Number of Participants With Severe AEs [DB Phase]. Trial comparisons, record NCT01632241-7de0197d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01632241-7de0197d
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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 | 0.139 | 0.106 | 0.18 | wilson | |
| Risk in group 2 | 0.224 | 0.167 | 0.294 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0853 | -0.162 | -0.0148 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.62 | 0.419 | 0.916 | log | |
| Odds ratio, group 1 over group 2 | 0.558 | 0.345 | 0.903 | log | |
| Number needed to treat, for one fewer participant with the outcome on Belimumab 10 mg/kg (DB Phase) than on Placebo (DB Phase) | 11.7 | 6.16 | 67.3 | 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 | Belimumab 10 mg/kg (DB Phase) | In DB phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care through 52 weeks. | 46 | 331 | OG001 |
| Group 2 | Placebo (DB Phase) | In DB phase, participants received matching placebo to belimumab administered as IV infusion plus standard of care through 52 weeks. | 37 | 165 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Severe AEs [DB Phase]
- Description
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with severe AEs have been presented.
- Time frame
- Up to 52 Weeks
- Population
- Safety Population
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
- NCT number
- NCT01632241
- Phases
- PHASE4
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Lead sponsor
- Human Genome Sciences Inc., a GSK Company
- Results first posted
- 2019-07-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01632241?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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