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Trial · NCT01335477

Outcomes29

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYAnnual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks.52 weeksTreated SetmL/yearMEAN
SECONDARYChange From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at 52 WeeksBaseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYTime to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation52 weeksTreated Setpercentage of participantsNUMBER
SECONDARYAbsolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 WeeksBaseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)mLMEAN
SECONDARYRelative Change From Baseline in Forced Vital Capacity (FVC) Over 52 WeeksBaseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)percent changeMEAN
SECONDARYAbsolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 WeeksBaseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)%predictedMEAN
SECONDARYRelative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 WeeksBaseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)percent changeMEAN
SECONDARYAbsolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 5% ThresholdBaseline and 52 weeksTreated Set (for patients with change from baseline in FVC (% predicted) at Week 52)percentage of participantsNUMBER
SECONDARYAbsolute Categorical Change From Baseline of FVC (% Predicted) by Categories Over 52 Weeks - 10% ThresholdBaseline and 52 weeksTreated Set (for patients with change from baseline in FVC (% predicted) at Week 52)percentage of participantsNUMBER
SECONDARYFVC Responders Using 10% Threshold at 52 Weeks52 weeksTreated Setpercentage of participantsNUMBER
SECONDARYProportion of FVC Responders Using 5% Threshold at 52 Weeks52 weeksTreated Setpercentage of participantsNUMBER
SECONDARYProportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Setpercentage of participantsNUMBER
SECONDARYChange From Baseline in SGRQ Symptom Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in Cough Symptom Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYChange From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)baseline and 52 weeksTreated Set (Only patients with observed cases (OC) values were analysed)points on a scaleMEAN
SECONDARYProportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)52 weeksTreated Setpercentage of participantsNUMBER

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.

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