Participant flow

Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma · Source last updated 2025-04-24

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

groups

1. description

   Nivolumab 3 mg/kg IV q2 wks and Ipilimumab placebo IV q3 wks for 4 doses then q12 wks starting at Wk 24

   id

   FG000

   title

   Nivolumab 3 mg/kg

2. description

   Ipilimumab 10 mg/kg IV q3 wks for 4 doses then q12 wks starting at Wk 24 and Nivolumab placebo IV q2 wks

   id

   FG001

   title

   Ipilimumab 10 mg/kg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant withdrew consent

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         453

      2. group Id

         FG001

         num Subjects

         453

      comment

      Started=Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         452

      2. group Id

         FG001

         num Subjects

         453

      comment

      completed=treated

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Pre-Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         121

      2. group Id

         FG001

         num Subjects

         100

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         208

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Adverse Event (AE) unrelated to study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         9

      type

      Participant request to stop treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Participant withdrew consent

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor/non-compliance

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer meets study criteria

   8. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Other reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         452

      2. group Id

         FG001

         num Subjects

         453

      comment

      Started=Treated

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         275

      2. group Id

         FG001

         num Subjects

         123

      comment

      Completed=Finished the treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         177

      2. group Id

         FG001

         num Subjects

         330

      type

      NOT COMPLETED

   title

   Treatment Period

pre Assignment Details

906 participants randomized and 905 treated. Reason for not treated: 1 participant withdrew consent.

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

Preserved source evidence · Not medical advice