Comparison · NCT01714817-sae
Abatacept IV vs Placebo IV: 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. Abatacept IV vs Placebo IV: serious adverse events. Trial comparisons, record NCT01714817-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01714817-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 | 0.307 | 0.247 | 0.374 | wilson | |
| Risk in group 2 | 0.286 | 0.228 | 0.351 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0212 | -0.0674 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.07 | 0.795 | 1.45 | log | |
| Odds ratio, group 1 over group 2 | 1.11 | 0.723 | 1.7 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Abatacept IV than on Placebo IV | 47.1 | 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 | Abatacept IV | Abatacept 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks | 62 | 202 | EG000 |
| Group 2 | Placebo IV | Placebo matching with Abatacept injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks | 58 | 203 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 1 up to 56 days post last dose (assessed up to May 2018, approximately 66 months)
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
- NCT number
- NCT01714817
- Phases
- PHASE3
- Conditions
- Lupus Nephritis
- Interventions
- BMS-188667, Mycophenolate mofetil, Prednisone, Placebo matching with BMS-188667
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2017-12-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01714817?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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