Participant flow

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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

groups

1. description

   Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

   id

   FG000

   title

   Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)

2. description

   Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

   id

   FG001

   title

   Atezolizumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         397

      2. group Id

         FG001

         num Subjects

         385

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         64

      type

      Study Terminated By Sponsor

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         464

      2. group Id

         FG001

         num Subjects

         467

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         443

      2. group Id

         FG001

         num Subjects

         459

      type

      Received Treatment

   3. achievements

      1. comment

         Participants still on chemotherapy were discontinued where that treatment was available locally.

         group Id

         FG000

         num Subjects

         0

      2. comment

         Participants still receiving atezolizumab had opportunity to continue treatment in extension study.

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         464

      2. group Id

         FG001

         num Subjects

         467

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice