Comparison · NCT00146640-sae
MR Prednisone vs IR Prednisone: 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. MR Prednisone vs IR Prednisone: serious adverse events. Trial comparisons, record NCT00146640-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00146640-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 | 0.0278 | 0.0109 | 0.0692 | wilson | |
| Risk in group 2 | 0.0208 | 0.00711 | 0.0595 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00694 | -0.0352 | 0.0506 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 0.304 | 5.85 | log | |
| Odds ratio, group 1 over group 2 | 1.34 | 0.295 | 6.11 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MR Prednisone than on IR Prednisone | 144 | 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 | MR Prednisone | Participants received tablets containing MR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) at bed time and placebo matching to IR prednisone tablet in the morning. Total duration of double blind treatment was 12 weeks. | 4 | 144 | EG000 |
| Group 2 | IR Prednisone | Participants received tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning and placebo matching to MR prednisone tablet at bed time. Total duration of double blind treatment was 12 weeks. | 3 | 144 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
- NCT number
- NCT00146640
- Phases
- PHASE3
- Conditions
- Rheumatoid Arthritis
- Interventions
- MR Prednisone, IR Prednisone, Placebo - MR Prednisone, Placebo - IR Prednisone
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Results first posted
- 2018-05-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00146640?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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