Comparison · NCT02971683-5c2fda2a
Abatacept + Standard Treatment vs Placebo + Standard Treatment: Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period
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: Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period. Trial comparisons, record NCT02971683-5c2fda2a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02971683-5c2fda2a
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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 | 0.187 | 0.115 | 0.289 | wilson | |
| Risk in group 2 | 0.127 | 0.0658 | 0.231 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0597 | -0.0669 | 0.179 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.47 | 0.66 | 3.28 | log | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.615 | 4.05 | log | |
| Number needed to treat, for one more participant with the outcome on Abatacept + Standard Treatment than on Placebo + Standard Treatment | 16.8 | 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 for the first 24 weeks (6 months) during the double-blind period. Participants continue to receive abatacept in the Open-Label and Long-Term Open Label Periods. | 14 | 75 | OG000 |
| Group 2 | Placebo + Standard Treatment | Participants receive placebo (to match subcutaneous abatacept) in combination with standard treatment for the first 24 weeks (6 months) during the double-blind period. Participants then switch from placebo to abatacept in the Open-Label and Long-Term Open Label Periods. | 8 | 63 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period
- Description
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
- Time frame
- From first dose up to approximately 56 days post last dose (up to approximately 54 months)
- Population
All participants who received at least one dose of abatacept. Participants are summarized under their actual Double-Blind treatment groups, but during the Open-Label and Long-Term Extension Periods all participants received abatacept.
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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