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Trial · NCT03785964

Results by group16

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

OutcomeGroupCategoryValueSpreadUnits
Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.Double-Blind Phase - NirogacestatNA95% Confidence Interval NA to NAMonths
Progression Free Survival (PFS) Defined as the Time From Randomization Until Date of Assessment of Progression or Death by Any Cause.Double-Blind Phase - Placebo15.195% Confidence Interval 8.4 to NAMonths
Objective Response Rate Using RECIST Version 1.1 Criteria.Double-Blind Phase - Nirogacestat4195% Confidence Interval 29.8 to 53.8percentage of participants
Objective Response Rate Using RECIST Version 1.1 Criteria.Double-Blind Phase - Placebo895% Confidence Interval 3.1 to 17.3percentage of participants
Change From Baseline at Cycle 10 in the Brief Pain Inventory (BPI) Average Pain Intensity (API) Score.Double-Blind Phase - Nirogacestat-1.58395% Confidence Interval -2.157 to -1.009score on a scale
Change From Baseline at Cycle 10 in the Brief Pain Inventory (BPI) Average Pain Intensity (API) Score.Double-Blind Phase - Placebo-0.24195% Confidence Interval -0.822 to 0.340score on a scale
Change From Baseline at Cycle 10 in the GOunder/Desmoid Tumor Research Tumor Foundation (DTRF) DEsmoid Tumor Symptom Scale (DTSS) - Total ScoreDouble-Blind Phase - Nirogacestat-1.11095% Confidence Interval -1.569 to -0.651score on a scale
Change From Baseline at Cycle 10 in the GOunder/Desmoid Tumor Research Tumor Foundation (DTRF) DEsmoid Tumor Symptom Scale (DTSS) - Total ScoreDouble-Blind Phase - Placebo0.45795% Confidence Interval -0.009 to 0.923score on a scale
Change From Baseline in the GOunder/Desmoid Tumor Research Foundation (DTRF) DEsmoid Tumor Impact Scale (DTIS) - Physical Functioning Domain ScoreDouble-Blind Phase - Nirogacestat-0.61395% Confidence Interval -0.808 to -0.418score on a scale
Change From Baseline in the GOunder/Desmoid Tumor Research Foundation (DTRF) DEsmoid Tumor Impact Scale (DTIS) - Physical Functioning Domain ScoreDouble-Blind Phase - Placebo0.09495% Confidence Interval -0.113 to 0.300score on a scale
Change From Baseline at Cycle10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale.
Double-Blind Phase - Nirogacestat2.93595% Confidence Interval -3.115 to 8.985score on a scale
Change From Baseline at Cycle10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Scale.
Double-Blind Phase - Placebo-8.46695% Confidence Interval -15.065 to -1.867score on a scale
Change From Baseline at Cycle 10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical FunctioningDouble-Blind Phase - Nirogacestat9.14395% Confidence Interval 5.619 to 12.668score on a scale
Change From Baseline at Cycle 10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Physical FunctioningDouble-Blind Phase - Placebo-5.22595% Confidence Interval -9.060 to -1.390score on a scale
Change From Baseline at Cycle 10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Role Functioning.Double-Blind Phase - Nirogacestat13.29395% Confidence Interval 7.080 to 19.506score on a scale
Change From Baseline at Cycle 10 in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Role Functioning.Double-Blind Phase - Placebo-5.59095% Confidence Interval -12.320 to 1.139score 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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