Comparison · NCT01632241-7773a809
Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) vs Placebo to Belimumab 10 mg/kg (OL Phase): Number of Participants With AEs Leading to Treatment Discontinuation [OL 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 to Belimumab 10 mg/kg (OL Phase) vs Placebo to Belimumab 10 mg/kg (OL Phase): Number of Participants With AEs Leading to Treatment Discontinuation [OL Phase]. Trial comparisons, record NCT01632241-7773a809. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01632241-7773a809
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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 | 0 | 0.0156 | wilson | |
| Risk in group 2 | 0.00855 | 0.00151 | 0.0468 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00855 | -0.0468 | 0.00859 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Belimumab 10 mg/kg to Belimumab 10 mg/kg (OL Phase) than on Placebo to Belimumab 10 mg/kg (OL Phase) | 117 | from the risk difference interval | the interval includes no difference |
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 to Belimumab 10 mg/kg (OL Phase) | In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76. | 0 | 242 | OG001 |
| Group 2 | Placebo to Belimumab 10 mg/kg (OL Phase) | In OL phase, participants received belimumab 10 mg/kg administered as IV infusion plus standard of care every 28 days from Week 52 through Week 76. | 1 | 117 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With AEs Leading to Treatment Discontinuation [OL 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 AEs leading to treatment discontinuation have been presented. For Safety, participants that completed DB and OL phase, an additional 8 weeks follow-up was conducted (Week 84).
- Time frame
- Week 52 to Week 84
- Population
- ITT OL 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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