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Trial · NCT04598477

Outcomes11

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYIncidence of Treatment-Emergent Adverse Events (TEAE), Adverse Events of Special Interest (AESI), and Serious Adverse Events (SAE)Up to 60 weeksSafety setnumber of events x 100/PYFUNUMBER
SECONDARYProportion of Participants With Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF) Who Achieve CRminUp to 60 weeksSafety setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYProportion of Participants With Pemphigus Vulgaris (PV) Who Achieve CRminUp to 60 weeksSafety set - Participants with PVParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTime to DC in Participants With PV and PFUp to 52 weeksSafety set - Participants with status DC at the roll-over visit were not included in the analysis.daysMEDIAN
SECONDARYTime to CR in Participants With PV and PFUp to 52 weeksSafety set - Participants with status CR at the roll-over visit were not included in this analysis.DaysMEDIAN
SECONDARYTime to CRmin in Participants With PV and PFUp to 52 weeksSafety set - Participants with status CRmin at the roll-over visit were not included in this analysis.daysMEDIAN
SECONDARYTime to CRoff in Participants With PV and PFUp to 52 weeksSafety set - Participants with status CRoff at the roll-over visit were not included in this analysis.daysMEDIAN
SECONDARYTime to Flare After CRmin in Participants With PV and PFUp to 52 weeksSafety set - Only participants who achieved CRmin were considered for the analysis.daysMEDIAN
SECONDARYRate of Treatment Failure in Participants With PV and PFUp to 52 weeksSafety setParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Flares in Participants With PV and PFUp to 60 weeksRoll-over set - Only participants who achieved DC were considered for the analysis.FlaresMEAN
SECONDARYNormalized Cumulative Prednisone Dose in Participants With PV and PFUp to 60 weeksRoll-over set - For participants that do not achieve CRmin (or CRoff), NCPD until CRmin (or CRoff) is not calculatedmg/kg/dayMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone 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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