Trial · NCT03099187
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Decline in Forced Vital Capacity (FVC) Over the 24-week Double-blind Treatment Period | Up to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | milliliter (mL) | MEAN |
| SECONDARY | Change in Percent Predicted FVC | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Percent predicted (%) | MEAN |
| SECONDARY | Change in FVC | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Liter (L) | MEAN |
| SECONDARY | Categorical Change in FVC of >5% | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Number of Participants | NUMBER |
| SECONDARY | Categorical Change in FVC of >10% | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Number of Participants | NUMBER |
| SECONDARY | Change in Percent Predicted Diffusing Capacity of the Lung for Carbon Monoxide (DLco) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | % predicted | MEAN |
| SECONDARY | Change in 6-minute Walk Distance (6MWD) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | meter (m) | MEAN |
| SECONDARY | Change in University of California, San Diego-Shortness of Breath Questionnaire Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change in Score in Leicester Cough Questionnaire Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Scores on a Scale | MEAN |
| SECONDARY | Change in Cough Visual Analog Scale (VAS) Score | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | millimeter (mm) | MEAN |
| SECONDARY | Change in Total and Sub-scores of the Saint George's Respiratory Questionnaire (SGRQ) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. Only participants for whom data were collected are included in the analysis. | Scores of a Scale | MEAN |
| SECONDARY | Number of Participants With Non-elective Hospitalization, Both Respiratory and All Cause | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Number of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Investigator-reported Acute Exacerbations | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Investigator-reported Acute Exacerbations | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Weeks | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Week | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Week | MEDIAN |
| SECONDARY | Time to Death From Any Cause | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Week | MEDIAN |
| SECONDARY | Time to Death From Respiratory Diseases | Baseline (Day 1) to Week 24 | The intent-to-treat (ITT) population was defined as all randomized participants. The ITT population was the primary analysis population for all efficacy analyses. | Week | MEDIAN |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline (Day 1) to Week 28 | 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. | Participants | NUMBER |
| SECONDARY | Number of Participants With Dose Reductions and Treatment Interruptions During the Double-Blind Period | From administration of the first dose of study drug to Week 24 | 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. | Number of Participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03099187/outcomes