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Trial · NCT01203943

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimarySafetyWeek 4Number of participants with adverse events
SecondaryLong-term safetyWeeks 52-104Number of participants with adverse events
SecondaryDisease progression/death ratesUp to week 56Time to disease progression and death
SecondaryDisease progression/death ratesWeeks 52-104Time to disease progression and death from week 52
SecondaryPharmacokinetics-CmaxWeek 1 (baseline) and week 2Maximum observed concentration in plasma
SecondaryPharmacokinetics-CminWeek 0 (baseline) and week 2Minimum observed concentration in plasma
SecondaryPharmacokinetics-AUCWeek 0 (baseline) and week 2Area under the plasma concentration - time curve
SecondaryPharmacokinetics-TmaxWeek 0 (baseline) and week 2Time to reach Cmax
SecondaryPharmacokinetics - t 1/2Week 0 (baseline) and week 2Terminal half-life (t1/2)
SecondaryPharmacokinetics-Vz/fWeek 0 (baseline) and week 2Apparent volume of distribution
SecondaryPharmacokinetics-CL/FWeek 0 (baseline) and week 2Apparent total body clearance

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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