Comparison · NCT01557322-sae
Etanercept vs nbDMARDs: 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. Etanercept vs nbDMARDs: serious adverse events. Trial comparisons, record NCT01557322-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01557322-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 | 0.365 | 0.303 | 0.432 | wilson | |
| Risk in group 2 | 0.346 | 0.323 | 0.37 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0188 | -0.0477 | 0.0896 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.871 | 1.28 | log | |
| Odds ratio, group 1 over group 2 | 1.09 | 0.805 | 1.46 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Etanercept than on nbDMARDs | 53.1 | 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 | Etanercept | Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (\>) 3.2 to less than or equal to (\<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity. | 77 | 211 | EG000 |
| Group 2 | nbDMARDs | Biological naïve participants with moderate RA, defined as DAS28 \>3.2 to \<=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity. | 534 | 1,543 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
- NCT number
- NCT01557322
- Phases
- Conditions
- Rheumatoid Arthritis
- Interventions
- etanercept, methotrexate (MTX)
- Lead sponsor
- Pfizer
- Results first posted
- 2013-10-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01557322?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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