Comparison · NCT02808871-sae
Pirfenidone 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. Pirfenidone vs Placebo: serious adverse events. Trial comparisons, record NCT02808871-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02808871-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 | 0.161 | 0.09 | 0.272 | wilson | |
| Risk in group 2 | 0.183 | 0.106 | 0.299 | wilson | |
| Risk difference, group 1 minus group 2 | -0.022 | -0.158 | 0.113 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.88 | 0.404 | 1.92 | log | |
| Odds ratio, group 1 over group 2 | 0.857 | 0.334 | 2.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Pirfenidone than on Placebo | 45.4 | 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 | Pirfenidone | Pirfenidone 2403 mg/d for 52 weeks | 10 | 62 | EG000 |
| Group 2 | Placebo | Placebo for 52 weeks | 11 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Each participant was assessed for development of AE's from time of first dose of study drug through last study visit (56 weeks) or until withdrawal from study. Mean time period of AE monitoring per study subject was 51.5 weeks (SD 12.86).
Source ClinicalTrials.gov
Trial
- Title
- Phase ll Study of Pirfenidone in Patients With RAILD (TRAIL1)
- NCT number
- NCT02808871
- Phases
- PHASE2
- Conditions
- Rheumatoid Arthritis Interstitial Lung Disease
- Interventions
- Pirfenidone, Placebo
- Lead sponsor
- Brigham and Women's Hospital
- Results first posted
- 2022-08-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02808871?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT02808871-sae