Comparison · NCT01594333-sae
Methotrexate vs Placebo: 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. Methotrexate vs Placebo: serious adverse events. Trial comparisons, record NCT01594333-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01594333-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 | 0.238 | 0.221 | 0.255 | wilson | |
| Risk in group 2 | 0.229 | 0.213 | 0.246 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00875 | -0.0152 | 0.0327 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.04 | 0.937 | 1.15 | log | |
| Odds ratio, group 1 over group 2 | 1.05 | 0.918 | 1.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Methotrexate than on Placebo | 114 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Methotrexate | Methotrexate: Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week | 569 | 2,391 | EG000 |
| Group 2 | Placebo | Placebo: Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week | 549 | 2,395 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From randomization to the trial end (April 2, 2018) - up to 5 years.
Source ClinicalTrials.gov
Trial
- Title
- Cardiovascular Inflammation Reduction Trial
- NCT number
- NCT01594333
- Phases
- PHASE3
- Conditions
- Cardiovascular Disease
- Interventions
- Methotrexate, Placebo
- Lead sponsor
- Brigham and Women's Hospital
- Results first posted
- 2020-07-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01594333?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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