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Trial · NCT01955837

Results by group120

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Overall Survival(OS)TAS-102(Trifluridine/Tipiracil)7.895% Confidence Interval 7.1 to 8.8Months
Overall Survival(OS)Placebo7.195% Confidence Interval 5.9 to 8.2Months
Progression-free Survival (PFS)TAS-102(Trifluridine/Tipiracil)2.095% Confidence Interval 1.9 to 2.8Months
Progression-free Survival (PFS)Placebo1.895% Confidence Interval 1.7 to 1.8Months
Time to Treatment Failure (TTF)TAS-102(Trifluridine/Tipiracil)1.995% Confidence Interval 1.9 to 2.2months
Time to Treatment Failure (TTF)Placebo1.895% Confidence Interval 1.7 to 1.8months
Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria)TAS-102(Trifluridine/Tipiracil)1.195% Confidence Interval 0.2 to 3.3percentage of participants
Overall Response Rate (ORR; Complete Response [CR] or Partial Response [PR] Using RECIST Criteria)Placebo0.095% Confidence Interval 0.0 to 2.8percentage of participants
Disease Control Rate (DCR; CR, PR, or Stable Disease)TAS-102(Trifluridine/Tipiracil)44.195% Confidence Interval 37.9 to 50.3percentage of participants
Disease Control Rate (DCR; CR, PR, or Stable Disease)Placebo14.695% Confidence Interval 9.0 to 21.9percentage of participants
Duration of ResponseTAS-102(Trifluridine/Tipiracil)6.695% Confidence Interval 3.9 to 9.2Months
Duration of ResponsePlacebo095% Confidence Interval 0 to 0Months
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)TAS-102(Trifluridine/Tipiracil)No AEs2Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)PlaceboNo AEs15Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)TAS-102(Trifluridine/Tipiracil)One or more AEs269Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)PlaceboOne or more AEs120Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)TAS-102(Trifluridine/Tipiracil)One or more TEAEs269Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)PlaceboOne or more TEAEs118Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)TAS-102(Trifluridine/Tipiracil)TEAE severity by CTCAE grade:Grade123Participants
Safety and Tolerability Evaluation Will Focus on Adverse Events and Laboratory Assessments(Adverse Events)PlaceboTEAE severity by CTCAE grade:Grade132Participants

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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