Participant flow

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer · Source last updated 2025-11-18

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

groups

1. description

   Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.

   id

   FG000

   title

   Nivolumab

2. description

   Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant request to discontinue treatment

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer meeting study criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         532

      2. group Id

         FG001

         num Subjects

         262

      comment

      Started = randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         532

      2. group Id

         FG001

         num Subjects

         260

      comment

      Completed = Entering the treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Pre-treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         152

      2. group Id

         FG001

         num Subjects

         115

      type

      Disease recurrence

   2. reasons

      1. group Id

         FG000

         num Subjects

         56

      2. group Id

         FG001

         num Subjects

         8

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse event unrelated to study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         5

      type

      Participant request to discontinue treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         4

      type

      Participant withdrew consent

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Poor/Non-compliance

   9. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         532

      2. group Id

         FG001

         num Subjects

         260

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         260

      2. group Id

         FG001

         num Subjects

         116

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         272

      2. group Id

         FG001

         num Subjects

         144

      type

      NOT COMPLETED

   title

   Treatment Period

pre Assignment Details

794 participants were randomized and 792 were treated. The reasons for the 2 participants not being treated were: Participant request to discontinue study treatment (1) and Participant no longer meeting study criteria (1).

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Preserved source evidence · Not medical advice