Comparison · NCT03099187-73038f1c
Pirfenidone vs Placebo: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03099187-73038f1c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03099187-73038f1c
On this page
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 | 0.945 | 0.891 | 0.973 | wilson | |
| Risk in group 2 | 0.815 | 0.737 | 0.873 | wilson | |
| Risk difference, group 1 minus group 2 | 0.13 | 0.0505 | 0.213 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 1.06 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 3.9 | 1.61 | 9.47 | log | |
| Number needed to treat, for one more participant with the outcome on Pirfenidone than on Placebo | 7.67 | 4.7 | 19.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Pirfenidone | Participants received pirfenidone 267 mg capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24. | 120 | 127 | OG000 |
| Group 2 | Placebo | Participants received matching placebo capsule three times a day from Day 1 to 7 followed by 2 capsules three times a day from Day 8 to 14 then 3 capsules three times a day from Day 15 up to Week 24. | 101 | 124 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
- Time frame
- Baseline (Day 1) to Week 28
- Population
The safety population was defined as all participants with at least one intake of pirfenidone or placebo, i.e., at least one record in the drug-log of the double-blind period with a non-zero dose. Participants in the safety population were assigned to a treatment arm according to the actual treatment they received.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
- NCT number
- NCT03099187
- Phases
- PHASE2
- Conditions
- Lung Diseases, Interstitial
- Interventions
- Pirfenidone, Placebo
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2020-01-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03099187?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03099187-73038f1c