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Trial · NCT01587703

Outcomes80

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QDMedian of 1.38 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With AEs and SAEs-Part 1 BIDMedian of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With AEs and SAEs-Part 2Median of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Dose Reductions or Delays-Part 1 QDMedian of 1.38 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Dose Reductions or Delays-Part 1 BIDMedian of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Dose Reductions or Delays-Part 2Median of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Dose Reductions or Delays-Besylate Sub-studyMedian of 1.87 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Withdrawn Due to Toxicities-Part 1 QDMedian of 1.38 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Withdrawn Due to Toxicities-Part 1 BIDMedian of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Withdrawn Due to Toxicities-Part 2Median of 1.41 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants Withdrawn Due to Toxicities-Besylate Sub-studyMedian of 1.87 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 QDBaseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1 BIDBaseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Clinical Chemistry Data-Besylate Sub-studyBaseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Hematology Data-Part 1 QDBaseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Hematology Data-Part 1 BIDBaseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Hematology Data-Part 2Baseline (pre-dose Week1 Day1) and median of 1.41 months of drug exposureAll Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Grade Change From Baseline in Hematology Data-Besylate Sub-studyBaseline (pre-dose Week1 Day1) and median of 1.87 months of drug exposureAll Treated PopulationParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYNumber of Participants With Maximum Urinalysis Change From Baseline-Part 1 QDBaseline (pre-dose Week1 Day1) and Weeks 5, 9, 17, 25, 33, 41, 49 and discharge/progression (disc/prog)All Treated Population. Only those participants with data available at the specified time points were analyzed (indicated by n=X in category titles).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.

For software

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GET https://conductscience.org/api/trials/v1/NCT01587703/outcomes