Comparison · NCT00422227-sae
ETN/MTX vs DMARD/MTX: 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. ETN/MTX vs DMARD/MTX: serious adverse events. Trial comparisons, record NCT00422227-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00422227-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 | 0.0305 | 0.014 | 0.0648 | wilson | |
| Risk in group 2 | 0.0291 | 0.00995 | 0.0822 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00133 | -0.0542 | 0.0407 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.267 | 4.1 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.256 | 4.28 | log | |
| Number needed to harm, for one more participant with a serious adverse event on ETN/MTX than on DMARD/MTX | 752 | 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 | ETN/MTX | Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection. | 6 | 197 | EG000 |
| Group 2 | DMARD/MTX | Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy. | 3 | 103 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region
- NCT number
- NCT00422227
- Phases
- PHASE4
- Conditions
- Rheumatoid Arthritis
- Interventions
- Etanercept , Methotrexate, Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Results first posted
- 2010-08-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00422227?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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