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Trial · NCT01769196

Outcomes12

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYProgression Free SurvivalUp to 148 weeksITT Analysis SetmonthsMEDIAN
PRIMARYPFS Among the Participants With sLOXL2 ≥ 50th PercentileUp to 148 weeksParticipants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.monthsMEDIAN
PRIMARYPFS Among the Participants With sLOXL2 ≥ 75th PercentileUp to 148 weeksParticipants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.monthsMEDIAN
SECONDARYOverall Survival (OS)Up to 151 weeksITT Analysis SetmonthsMEDIAN
SECONDARYOverall Survival Among the Participants With sLOXL2 ≥ 50th PercentileUp to 151 weeksParticipants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.monthsMEDIAN
SECONDARYOverall Survival Among the Participants With sLOXL2 ≥ 75th PercentileUp to 151 weeksParticipants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.monthsMEDIAN
SECONDARYRelative Change From Baseline in FVC % PredictedWeeks 54, 106, and 130
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
Percent change in FVC % predictedLEAST_SQUARES_MEAN
SECONDARYDefinite Acute Exacerbations of IPF Among Adjudicated Respiratory HospitalizationsUp to 148 weeksParticipants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Adjudicated Respiratory Hospitalizations (ARP) Among Total HospitalizationsUp to 148 weeksParticipants in ITT Analysis Set with total hospitalizations were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated DeathUp to 148 weeksParticipants in the ITT Analysis Set with adjudicated deaths were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAbsolute Change From Baseline in 6 Minute Walk Distance (6MWD)Weeks 58, 106, and 130
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
MetersLEAST_SQUARES_MEAN
SECONDARYAbsolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) ScoreWeek 58, 106, and 130
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
units on a scaleLEAST_SQUARES_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.

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