Comparison · NCT02971683-sae
Abatacept + Standard Treatment vs Placebo + Standard Treatment: 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 + Standard Treatment vs Placebo + Standard Treatment: serious adverse events. Trial comparisons, record NCT02971683-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02971683-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 | 0.159 | 0.108 | 0.23 | wilson | |
| Risk in group 2 | 0.0685 | 0.0296 | 0.151 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0909 | -0.00605 | 0.171 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.33 | 0.92 | 5.89 | log | |
| Odds ratio, group 1 over group 2 | 2.58 | 0.934 | 7.13 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Abatacept + Standard Treatment than on Placebo + Standard Treatment | 11 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Abatacept + Standard Treatment | Participants receive subcutaneous abatacept (125 mg weekly) in combination with standard treatment during the cumulative abatacept period. | 22 | 138 | EG000 |
| Group 2 | Placebo + Standard Treatment | Participants receive placebo (to match subcutaneous abatacept) in combination with standard treatment during the double-blind period. | 5 | 73 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality was assessed from participants first dose to their study completion (up to approximately 55 months) SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 55 months)
Source ClinicalTrials.gov
Trial
- Title
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
- NCT number
- NCT02971683
- Phases
- PHASE3
- Conditions
- Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18
- Interventions
- Abatacept subcutaneous, Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2021-09-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02971683?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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