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Trial · NCT00343460

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryProportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 10-24 HoursComplete Response is defined as no emetic episodes and no use of rescue medications
PrimaryProportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 124-120 HoursComplete Response is defined as no emetic episodes and no use of rescue medications
SecondaryProportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 10-120 HoursComplete control is defined as complete response with no more than mild nausea.
SecondaryProportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 10-120 Hours
TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1. TR during delayed-onset phase is defined as Complete Response with no nausea during \>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.
SecondaryNumber of Emetic EpisodesDays 1-5Number of Emetic Episodes - days 1-5
SecondaryTime to First Treatment Failure0-120 HoursProportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration
SecondaryFirst and Overall Use of Rescue Medication0-120 Hours
SecondarySeverity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)0-120 HoursMaximum severity of nausea, days 1-5
SecondarySustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses0-120 HoursSustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles Complete Response is defined as no emetic episodes and no use of rescue medications
SecondaryQuality of Life and the Impact of Nausea and Vomiting on Day 55 daysFunctional Living Index
SecondaryPatient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 10- 24 HoursSubject who were very satisfied on Day 1

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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