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Trial · NCT02723955

Outcomes80

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPart 1A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)Up to approximately 367 weeksAll Treated population included all participants who received at least one dose of feladilimab.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Dose Limiting Toxicity (DLT)Up to 28 days
DLT Evaluable Population included All Treated Population in the dose escalation phase or PK/PD cohorts, who completed the 28-day DLT observation period or experienced a DLT during the determinative period (28 days).
ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to BaselineUp to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to BaselineUp to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to BaselineUp to approximately 367 weeksAll treated population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 1A: Number of Participants With Dose Modifications of FeladilimabUp to approximately 367 weeksAll treated populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)Up to approximately 367 weeksAll Treated populationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Dose Limiting Toxicity (DLT)Up to 28 daysDLT Evaluable Population. As pre-specified in the protocol, only specified treatment arms were planned and hence there are 0 participants analyzed for rest of the arms.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to BaselineUp to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Worst Case Hematology Results Relative to Normal Range Post-Baseline Relative to BaselineUp to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to BaselineUp to approximately 367 weeksAll treated population. Only those participants with data available at specified categories have been analyzedParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYPart 2A: Number of Participants With Dose Modifications of FeladilimabUp to approximately 367 weeksAll Treated populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart 1B: Number of Participants With Any Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs)Up to approximately 367 weeksAll Treated populationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart 1B: Number of Participants With Worst-case Grade Change From Baseline in Clinical Chemistry ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart 1B: Number of Participants With Worst Case Chemistry Results Relative to Normal Range Post-Baseline Relative to BaselineUp to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPart 1B: Number of Participants With Worst-case Grade Change From Baseline in Hematology ParametersBaseline (Day 1) and up to approximately 367 weeksAll Treated Population. Only those participants with data available at specified categories have been analyzed.ParticipantsCOUNT_OF_PARTICIPANTS

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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