Trial · NCT01766817
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26 | Baseline, Week 26 | Intent-to-treat (ITT) population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | liters (L) | MEAN |
| SECONDARY | Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | Ratio | NUMBER |
| SECONDARY | Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | meters (m) | MEAN |
| SECONDARY | Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | Unit on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure. | liters | MEAN |
| SECONDARY | Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for each category. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Death or Non-Elective Hospitalization | Upto Day 210 | Safety population included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD) | Upto Day 210 | Safety Population included all enrolled participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26 | Baseline, Week 26 | ITT population included all randomized participants.Here 'n' 'number analyzed' signifies number of participants who were evaluable for each category. | mL/min/mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF) | Upto Day 210 | ITT population included all randomized participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) BMS-986020 | Day 1 and Day 7 | Evaluable pharamcokinetic (PK) population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point. | microgram per liter (ug/L) | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020 | Day 1 and Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point. | hours (h) | MEDIAN |
| SECONDARY | Accumulation Index (AI) of BMS-986020 | Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable this outcome measure. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state | Day 1 and Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point. | ug*h/L | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020 | Day 1 and Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point. | ug*h/L | GEOMETRIC_MEAN |
| SECONDARY | Apparent Oral Clearance (CLF/F) of BMS -986020 | Day 1 and Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point. | Liter per hour (L/h) | GEOMETRIC_MEAN |
| SECONDARY | Average Concentration of BMS -986020 at Steady State (Css[Avg]) | Day 7 | Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at this time point. | ug/L | GEOMETRIC_MEAN |
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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