Participant flow

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein · Source last updated 2023-01-20

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

groups

1. description

   8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

   id

   FG000

   title

   Ramucirumab + BSC

2. description

   Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

   id

   FG001

   title

   Placebo + BSC

3. description

   8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

   id

   FG002

   title

   Open Label Ramucirumab + BSC

4. description

   8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

   id

   FG003

   title

   Ramucirumab MEE Cohort

5. description

   Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

   id

   FG004

   title

   Placebo MEE Cohort

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         95

      3. group Id

         FG002

         num Subjects

         47

      4. group Id

         FG003

         num Subjects

         39

      5. group Id

         FG004

         num Subjects

         21

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         197

      2. group Id

         FG001

         num Subjects

         95

      3. group Id

         FG002

         num Subjects

         47

      4. group Id

         FG003

         num Subjects

         39

      5. group Id

         FG004

         num Subjects

         21

      type

      Participants Who Received Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         193

      2. group Id

         FG001

         num Subjects

         90

      3. group Id

         FG002

         num Subjects

         42

      4. group Id

         FG003

         num Subjects

         38

      5. group Id

         FG004

         num Subjects

         21

      comment

      Completers include participants who had died due to any cause or alive and on study at the end of study, but off treatment.

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

c. China Maximized Extended Enrollment: This is an extension phase of the main study, with an additional 60 participants enrolled in China. Safety was monitored and data was reported under AE section.

recruitment Details

1. Main study: Participants who received sorafenib as first-line therapy were randomized to ramucirumab or placebo. 2. Open-Label Expansion: Participants who were not previously treated with sorafenib were enrolled into this single-arm addenda and treated with ramucirumab. The purpose of this addenda is to monitor safety, and data was reported under AE section. (Continued...)

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Preserved source evidence · Not medical advice