Participant flow

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma · Source last updated 2020-08-20

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

groups

1. description

   Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.

   id

   FG000

   title

   Placebo

2. description

   Subjects received regorafenib 160 milligram (mg) (4 \* 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.

   id

   FG001

   title

   Regorafenib 160 mg (BAY73-4506)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         10

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      End of survival follow-up not available

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         14

      type

      Data collection finished

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   7. reasons

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         83

      type

      Did not enter Survival Follow up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         194

      2. group Id

         FG001

         num Subjects

         379

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         193

      2. group Id

         FG001

         num Subjects

         374

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         145

      2. group Id

         FG001

         num Subjects

         291

      type

      Entered Survival FU

   4. achievements

      1. group Id

         FG000

         num Subjects

         132

      2. group Id

         FG001

         num Subjects

         258

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         62

      2. group Id

         FG001

         num Subjects

         121

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Overall, 843 subjects were screened, of them 270 subjects were screening failures. 573 subjects were randomized and assigned to treatment; of them 6 subjects never received treatment. 436 Entered survival Follow-up and 4 End of survival follow-up data not available.

recruitment Details

The study was conducted between 14 May 2013 (first subject first visit), 29 February 2016 (primary completion date) and 05-July-2019 (Last Patient Last Visit =End of study).

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

Preserved source evidence · Not medical advice