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Trial · NCT03347292

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of treatment-emergent adverse event(TEAEs)Up to 30 days after last dose of study drugThe incidence of treatment-emergent adverse events and treatment-emergent drug-related adverse events summarized in frequency tables using worst CTCAE v4.03 grade.
PrimarySeverity of TEAEsUp to 30 days after last dose of study drug
PrimaryDose Limiting Toxicities(DLTs)Up to 42 days after first treatment administration
SecondaryMaximum Tolerated Dose (MTD)After approximately 18 monthsThe MTD is defined as the highest dose that can be given so that toxicity probability is below the target toxicity PT =35%.
SecondaryProgression-free survival (PFS)After approximately 36 months
SecondaryTime to progression (TTP)After approximately 36 months
SecondaryOverall survival (OS)After approximately 36 months
SecondaryOverall response rate (ORR)After approximately 36 months
SecondaryDisease control rate (DCR)After approximately 36 months
SecondaryDuration of response (DOR)After approximately 36 months
SecondaryDuration of stable diseaseAfter approximately 36 months

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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