Comparison · NCT01705977-sae
Belimumab 10 mg/kg 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. Belimumab 10 mg/kg vs Placebo: serious adverse events. Trial comparisons, record NCT01705977-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01705977-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 | 0.116 | 0.103 | 0.131 | wilson | |
| Risk in group 2 | 0.12 | 0.107 | 0.135 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00406 | -0.0241 | 0.016 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.966 | 0.816 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.962 | 0.794 | 1.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Belimumab 10 mg/kg than on Placebo | 247 | 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). | 233 | 2,002 | EG001 |
| 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). | 241 | 2,001 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- AESIs and all SAEs were collected up to Week 52 (On-study period), all-cause mortality was collected up to end of study (up to 5 years)
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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