Comparison · NCT01705977-7c85a232
Belimumab 10 mg/kg vs Placebo: Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
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 vs Placebo: Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52). Trial comparisons, record NCT01705977-7c85a232. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01705977-7c85a232
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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 | 0.11 | 0.0969 | 0.124 | wilson | |
| Risk in group 2 | 0.111 | 0.0979 | 0.125 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00105 | -0.0205 | 0.0184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.99 | 0.831 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.989 | 0.812 | 1.21 | log | |
| Number needed to treat, for one fewer participant with the outcome on Belimumab 10 mg/kg than on Placebo | 948 | 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 | Participants received belimumab 10 milligrams per kilogram (mg/kg) on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years). | 220 | 2,002 | OG001 |
| Group 2 | Placebo | Participants received placebo via the intravenous route on Days 0, 14, 28 and every 28 days through Week 48 with a final visit conducted at Week 52. Participants continued to receive standard SLE treatment and were followed up until end of study (up to 5 years). | 222 | 2,001 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Serious Adverse Events (SAEs) Reported During On-treatment Period (Week 52)
- Description
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgement. The on-treatment period (Week 52) was defined as first dose to last dose + 28 days (or death) and was the primary analysis period for safety analyses.
- Time frame
- Up to Week 52 (On-treatment period)
- Population
- As-Treated Population. One participant in placebo group who received belimumab \>50% of the time was reported in the belimumab group.
Source ClinicalTrials.gov
Trial
- Title
- Belimumab Assessment of Safety in SLE
- NCT number
- NCT01705977
- Phases
- PHASE4
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Placebo plus standard therapy, Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2019-11-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01705977?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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