Participant flow

Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma · Source last updated 2025-02-24

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

groups

1. description

   Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

   id

   FG000

   title

   Placebo+Gemcitabine+Carboplatin/Cisplatin

2. description

   Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).

   id

   FG001

   title

   Atezolizumab+Gemcitabine+Carboplatin/Cisplatin

3. description

   Eligible participants received open-label atezolizumab as monotherapy.

   id

   FG002

   title

   Atezolizumab Monotherapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         6

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Deviation

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Symptomatic Deterioration

   4. reasons

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         28

      3. group Id

         FG002

         num Subjects

         24

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         303

      2. group Id

         FG001

         num Subjects

         332

      3. group Id

         FG002

         num Subjects

         272

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         47

      2. group Id

         FG001

         num Subjects

         76

      3. group Id

         FG002

         num Subjects

         60

      type

      Study Terminated By Sponsor

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         400

      2. group Id

         FG001

         num Subjects

         451

      3. group Id

         FG002

         num Subjects

         362

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         400

      2. group Id

         FG001

         num Subjects

         451

      3. group Id

         FG002

         num Subjects

         362

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Stage 1 included atezolizumab+gemcitabine+carboplatin arm or placebo+gemcitabine+carboplatin arm. Participants ineligible for cisplatin-based chemo were enrolled in this stage. Stage 2 included addition of atezolizumab monotherapy arm and allowed participants who were eligible for cisplatin-based chemotherapy. Study is considered "Completed" because all pre-planned study analyses have been preformed for primary and secondary endpoints.

recruitment Details

Participants were enrolled in 221 sites in 35 countries.

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Preserved source evidence · Not medical advice