Participant flow

An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma · Source last updated 2025-02-17

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

groups

1. description

   Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity

   id

   FG000

   title

   Nivolumab 240 mg

2. description

   Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity

   id

   FG001

   title

   Sorafenib 400 mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant request to stop therapy

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         5

      type

      Participant withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant no longer meets criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         371

      2. group Id

         FG001

         num Subjects

         372

      comment

      Started = Assigned to treatment (randomized/enrolled)

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         367

      2. group Id

         FG001

         num Subjects

         363

      comment

      Completed = Entering treatment period

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Pre-Treatment Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         263

      2. group Id

         FG001

         num Subjects

         244

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         41

      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

         39

      2. group Id

         FG001

         num Subjects

         41

      type

      Adverse event unrelated to study drug

   5. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         18

      type

      Participant request to stop treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         7

      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

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Maximum clinical benefit

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor/non-compliance

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Participant no longer meets criteria

   11. reasons

       1. group Id

          FG000

          num Subjects

          12

       2. group Id

          FG001

          num Subjects

          8

       type

       Other reason

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       NOT REPORTED

   Show more (12 of 13)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         367

      2. group Id

         FG001

         num Subjects

         363

      comment

      Started = Received treatment

      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

         367

      2. group Id

         FG001

         num Subjects

         363

      type

      NOT COMPLETED

   title

   Treatment Period

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Preserved source evidence · Not medical advice