Participant flow

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Metastatic Non-squamous NSCLC · Source last updated 2023-02-08

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 solution administered intravenously every 2 weeks. Eligible participants transitioned to nivolumab 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

   id

   FG000

   title

   Nivolumab

2. description

   Docetaxel 75mg/m\^2 solution administered intravenously every 3 weeks. Eligible participants transitioned to nivolumab 3 mg/kg every 2 weeks or 480 mg every 4 weeks. Participants treated until disease progression, discontinuation due to toxicity, withdrawal of consent or end of study.

   id

   FG001

   title

   Docetaxel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse event unrelated to study drug

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Participant request to discontinue study treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by participant

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      type

      Participant no longer meets study criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         292

      2. group Id

         FG001

         num Subjects

         290

      comment

      Started = Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         287

      2. group Id

         FG001

         num Subjects

         268

      comment

      Completed = Received treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         22

      type

      NOT COMPLETED

   title

   Randomization

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         208

      2. group Id

         FG001

         num Subjects

         178

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         43

      type

      Study Drug Toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         10

      type

      Adverse event unrelated to study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         17

      type

      Participant request to discontinue study treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         5

      type

      Withdrawal by participant

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         10

      type

      Maximum clinical benefit

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant no longer meets study criteria

   9. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Administrative reason by sponsor

   10. reasons

       1. group Id

          FG000

          num Subjects

          11

       2. group Id

          FG001

          num Subjects

          2

       type

       Other reason

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         287

      2. group Id

         FG001

         num Subjects

         268

      comment

      Started = Received treatment

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         17

      type

      Participants Who Transitioned to Nivolumab 3 mg/kg

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         1

      type

      Participants Who Transitioned to Nivolumab 480 mg

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      comment

      Completed = Completed treatment period

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         285

      2. group Id

         FG001

         num Subjects

         268

      type

      NOT COMPLETED

   title

   Treatment

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

Preserved source evidence · Not medical advice