Comparison · NCT02312219-sae
Low Dose 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. Low Dose Methotrexate vs Placebo: serious adverse events. Trial comparisons, record NCT02312219-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02312219-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 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.194 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Low Dose Methotrexate | Subjects will take 1 mg folic acid once daily plus 5 mg methotrexate (MTX) . If clinically stable at the week 1 visit, the dose of MTX will be increased to 10 mg once weekly through week 12. For subjects who remain clinically stable on 10 mg MTX or placebo through the week 12 visit, the dose of MTX will be increased to 15 mg once weekly through week 24. If the subject does not meet the criteria for dose escalation at the week 1 or 12 study visit, then the subject will remain on his/her current dose until the next study visit at which time he/she will be re-evaluated for dose escalation.~Folic Acid: 1 mg folic acid once daily~Low Dose Methotrexate: An anti-inflammatory drug | 0 | 12 | EG000 |
| Group 2 | Placebo | Subjects will take 1 mg folic acid once daily plus placebo once weekly. If clinically stable at weeks 1 and 12, the number of placebo tablets will be increased in a manner matching those on the MTX.~Folic Acid: 1 mg folic acid once daily~Placebo: placebo once weekly | 0 | 16 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- PET/CT Imaging Companion Study To ACTG A5314
- NCT number
- NCT02312219
- Phases
- Conditions
- HIV, Inflammation, Atherosclerosis
- Interventions
- Folic Acid, Placebo, Low Dose Methotrexate
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2019-02-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02312219?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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