Comparison · NCT01844518-sae
SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: 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. SC Abatacept Ages 6 to 17 vs SC Abatacept Ages 2 to 5: serious adverse events. Trial comparisons, record NCT01844518-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01844518-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 | 0.104 | 0.0668 | 0.158 | wilson | |
| Risk in group 2 | 0.13 | 0.0612 | 0.257 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0264 | -0.158 | 0.0617 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.798 | 0.336 | 1.89 | log | |
| Odds ratio, group 1 over group 2 | 0.774 | 0.288 | 2.08 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on SC Abatacept Ages 6 to 17 than on SC Abatacept Ages 2 to 5 | 37.9 | 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 | SC Abatacept Ages 6 to 17 | Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to less than (\<) 25 kilogram (kg) (50 milligram \[mg\] in 0.4 milliliter \[mL\] PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 18 | 173 | EG000 |
| Group 2 | SC Abatacept Ages 2 to 5 | SC abatacept administered by PFS once weekly according to the following weight-tiered dosing regimen: 10 to \< 25 kg (50 mg in 0.4 mL PFS), 25 to \< 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS). | 6 | 46 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 113 months). SAEs and Other AEs were assessed from first dose to 168 days after last dose of study therapy (assessed up to approximately 113 months).
Source ClinicalTrials.gov
Trial
- Title
Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
- NCT number
- NCT01844518
- Phases
- PHASE3
- Conditions
- Active Polyarticular Juvenile Idiopathic Arthritis
- Interventions
- Abatacept
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2016-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01844518?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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