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Trial · NCT03564938

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryNumber of Adverse EventsFrom the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryChanges in Eastern Cooperative Oncology Group Performance Status (ECOG PS)From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryPercentage of participants with change in worst grades for hematological and biochemical toxicities according to CTCAE version 4.03, based on laboratory measurementsFrom the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryChange in Body weight (kg)From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryChange in Body height (cm)From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryChange in Systolic / Diastolic BP (mmHg)From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
PrimaryChange in heart rate (beats/min)From the start of regorafenib treatment up to 30 days after the last dose of regorafenib
SecondaryDisease control rate (DCR)In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs firstDefined as proportion of patients achieving complete response (CR), partial response (PR), or SD (stable disease) per Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1
SecondaryOverall response rate (ORR)In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs firstDefined as proportion of patients achieving CR, and PR per RECIST v.1.1
SecondaryProgression free survival (PFS)In each participant, every 8 weeks from the start of regorafenib until radiological disease progression, lost to follow-up, consent withdrawn or end of study, whichever occurs firstProgression free survival is defined as the time from study drug assignment to progressive disease (PD) or death from any cause or date of last tumor assessment if the patient did not progress or die.
SecondaryOverall survival (OS)In each participant, every 8 weeks from the start of regorafenib until death, lost to follow-up, consent withdrawn or end of study, whichever occurs firstOverall survival is defined as the time from study drug assignment to death from any cause or last date when the patient was known to be alive.

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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