Participant flow

Study of Nivolumab (BMS-936558) Compared With Dacarbazine in Untreated, Unresectable, or Metastatic Melanoma · Source last updated 2022-07-12

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

groups

1. description

   Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

   id

   FG000

   title

   Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine

2. description

   Participants received dacarbazine 1000 mg/m\^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion

   id

   FG001

   title

   Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer meets study criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor/non-compliance

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant withdrew consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse event unrelated to study drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         210

      2. group Id

         FG001

         num Subjects

         208

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         205

      comment

      Moving to the treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Pre-Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         119

      2. group Id

         FG001

         num Subjects

         168

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         10

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse event unrelated to study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         4

      type

      Maximum clinical benefit

   5. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         2

      type

      Other

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         5

      type

      Participant withdrew consent

   7. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         8

      type

      Participant request to discontinue study treatment

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Not reported

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Poor/non-compliance

   11. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         205

      comment

      Treated

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         206

      2. group Id

         FG001

         num Subjects

         205

      type

      NOT COMPLETED

   title

   Treatment

pre Assignment Details

418 were randomized (210 to nivolumab, 208 to dacarbazine) and 411 received treatment (206 with nivolumab, 205 with dacarbazine).

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Preserved source evidence · Not medical advice