Participant flow

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer · Source last updated 2026-07-30

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

groups

1. description

   Placebo

   id

   FG000

   title

   Placebo

2. description

   Nivolumab 240mg IV Q2W

   id

   FG001

   title

   Nivolumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      AE unrelated to study Drug

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      type

      No Longer meets study criteria

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         356

      2. group Id

         FG001

         num Subjects

         353

      comment

      = Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         351

      comment

      = Treated

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Randomized

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         21

      type

      Ongoing Treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         147

      2. group Id

         FG001

         num Subjects

         90

      type

      Disease Recurrence

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         49

      type

      Study Drug Toxicity

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         16

      type

      AE unrelated to study drug

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         19

      type

      Request to discontinue treatment

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         5

      type

      Participant withdrew consent

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Maximum clinical benefit

   10. reasons

       1. group Id

          FG000

          num Subjects

          3

       2. group Id

          FG001

          num Subjects

          0

       type

       No longer meets study criteria

   11. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Administrative Reason by sponsor

   12. reasons

       1. group Id

          FG000

          num Subjects

          10

       2. group Id

          FG001

          num Subjects

          6

       type

       Other Reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         351

      comment

      = Randomized and Treated

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         132

      2. group Id

         FG001

         num Subjects

         143

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         216

      2. group Id

         FG001

         num Subjects

         208

      type

      NOT COMPLETED

   title

   Treatment Period

pre Assignment Details

709 Participants Randomized, 699 Treated

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Preserved source evidence · Not medical advice