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Trial · NCT02500043

Results by group64

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

OutcomeGroupCategoryValueSpreadUnits
Overall Survival (OS)TAS-102+BSC5.795% Confidence Interval 4.8 to 6.2months
Overall Survival (OS)Placebo+BSC3.695% Confidence Interval 3.1 to 4.1months
Progression-Free Survival (PFS)TAS-102+BSC2.095% Confidence Interval 1.9 to 2.3months
Progression-Free Survival (PFS)Placebo+BSC1.895% Confidence Interval 1.7 to 1.9months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)TAS-102+BSCTEAE319Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)Placebo+BSCTEAE151Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)TAS-102+BSCTESAE143Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAE)Placebo+BSCTESAE70Participants
Overall Response Rate (ORR)TAS-102+BSC4.595% Confidence Interval 2.4 to 7.5percentage of participants
Overall Response Rate (ORR)Placebo+BSC2.195% Confidence Interval 0.4 to 5.9percentage of participants
Disease Control Rate (DCR)TAS-102+BSC44.195% Confidence Interval 38.3 to 50.1percentage of participants
Disease Control Rate (DCR)Placebo+BSC14.595% Confidence Interval 9.2 to 21.3percentage of participants
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From BaselineTAS-102+BSC4.395% Confidence Interval 3.7 to 4.7months
Time to Deterioration of European Cooperative Oncology Group (ECOG) Performance Status Score From BaselinePlacebo+BSC2.395% Confidence Interval 2.0 to 2.8months
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusTAS-102+BSCCycle 1-2.7Standard Deviation 17.56units on a scale
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusPlacebo+BSCCycle 1-5.9Standard Deviation 22.20units on a scale
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusTAS-102+BSCCycle 2-5.9Standard Deviation 20.51units on a scale
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusPlacebo+BSCCycle 2-7.3Standard Deviation 25.80units on a scale
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusTAS-102+BSCCycle 3-4.1Standard Deviation 18.26units on a scale
Change From Baseline in Quality of Life European Organization for Research and Treatment for Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30 Score): Global Health StatusPlacebo+BSCCycle 3-1.4Standard Deviation 22.00units on a scale

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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