Comparison · NCT00651040-sae
1 Prednison vs 2 Prednison Methotrexate: 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. 1 Prednison vs 2 Prednison Methotrexate: serious adverse events. Trial comparisons, record NCT00651040-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00651040-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 | 0.25 | 0.102 | 0.495 | wilson | |
| Risk in group 2 | 0.333 | 0.152 | 0.583 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0833 | -0.374 | 0.222 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.247 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 0.667 | 0.14 | 3.17 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on 1 Prednison than on 2 Prednison Methotrexate | 12 | 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 | 1 Prednison | Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms.~ARM 1 has only Prednisone~Prednisone: Prednisone will be administered orally, initially at 1.0 mg/kg/day dosage and then tapered gradually equally in the two arms | 4 | 16 | EG000 |
| Group 2 | 2 Prednison Methotrexate | MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose.~Methotrexate: MTX will be administered orally (in case of oral intolerance intramusculary (i.m.)), once weekly for 48 weeks. There will be a clinically oriented dose escalation starting from 10 up to 20-25 mg of MTX. Five to ten mg of folic acid will be given 24 hours after each methotrexate dose. | 5 | 15 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 year
Source ClinicalTrials.gov
Trial
- Title
- Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DM
- NCT number
- NCT00651040
- Phases
- PHASE3
- Conditions
- Polymyositis, Dermatomyositis
- Interventions
- Prednisone, Methotrexate
- Lead sponsor
- Institute of Rheumatology, Prague
- Results first posted
- 2016-05-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00651040?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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