Participant flow

A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer · Source last updated 2024-08-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants in Cohort 1 had received prior treatment with platinum-containing chemotherapy. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

   id

   FG000

   title

   Enfortumab Vedotin - Cohort 1

2. description

   Participants in Cohort 2 had received no platinum-containing chemotherapy were ineligible for treatment with cisplatin at the time of enrollment. Enfortumab vedotin, at a dose of 1.25 mg/kg, was administered to participants as an IV infusion over approximately 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

   id

   FG001

   title

   Enfortumab Vedotin - Cohort 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         72

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         12

      type

      Study closed in 2023,as all milestones reached, majority of participants completed 5 years follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         128

      2. group Id

         FG001

         num Subjects

         91

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         125

      2. group Id

         FG001

         num Subjects

         89

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         128

      2. group Id

         FG001

         num Subjects

         91

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Eligible participants with locally advanced or metastatic urothelial cancer who have previously received systemic therapy with a programmed cell death protein-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitor and met inclusion criteria and none of the exclusion criteria were enrolled in the study.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice