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Trial · NCT03474107

Results by group22

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

OutcomeGroupCategoryValueSpreadUnits
Overall Survival (OS)Enfortumab Vedotin 1.25 mg/kg12.8895% Confidence Interval 10.58 to 15.21months
Overall Survival (OS)Chemotherapy8.9795% Confidence Interval 8.05 to 10.74months
Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Enfortumab Vedotin 1.25 mg/kg5.5595% Confidence Interval 5.32 to 5.82months
Progression Free Survival on Study Therapy (PFS1) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)Chemotherapy3.7195% Confidence Interval 3.52 to 3.94months
Overall Response Rate (ORR) as Per RECIST V1.1Enfortumab Vedotin 1.25 mg/kg40.695% Confidence Interval 34.90 to 46.54percentage of participants
Overall Response Rate (ORR) as Per RECIST V1.1Chemotherapy17.995% Confidence Interval 13.71 to 22.76percentage of participants
Disease Control Rate (DCR) as Per RECIST V1.1Enfortumab Vedotin 1.25 mg/kg71.995% Confidence Interval 66.30 to 76.99percentage of participants
Disease Control Rate (DCR) as Per RECIST V1.1Chemotherapy53.495% Confidence Interval 47.52 to 59.17percentage of participants
Duration of Response (DOR) as Per RECIST V1.1Enfortumab Vedotin 1.25 mg/kg7.3995% Confidence Interval 5.59 to 9.46months
Duration of Response (DOR) as Per RECIST V1.1Chemotherapy8.1195% Confidence Interval 5.65 to 9.56months
Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)Enfortumab Vedotin 1.25 mg/kg-2.30Standard Deviation 18.02score on a scale
Change From Baseline to Week 12 in European Organisation for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire Global Health Status (QL2 Score)Chemotherapy-5.72Standard Deviation 16.04score on a scale
Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)Enfortumab Vedotin 1.25 mg/kg-1.8Standard Deviation 16.6score on a scale
Change From Baseline to Week 12 in EuroQOL 5-dimension 5-level Questionnaire [EQ-5D-5L] Visual Analog Scale (VAS)Chemotherapy-5.3Standard Deviation 14.5score on a scale
Number of Participants With Treatment Emergent Adverse EventsEnfortumab Vedotin 1.25 mg/kg290participants
Number of Participants With Treatment Emergent Adverse EventsChemotherapy288participants
Number of Participants With ECOG Performance StatusEnfortumab Vedotin 1.25 mg/kgECOG PS = 034participants
Number of Participants With ECOG Performance StatusChemotherapyECOG PS = 057participants
Number of Participants With ECOG Performance StatusEnfortumab Vedotin 1.25 mg/kgECOG PS = 1110participants
Number of Participants With ECOG Performance StatusChemotherapyECOG PS = 1118participants

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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