Participant flow

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) · Source last updated 2024-10-26

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

groups

1. description

   Participants diagnosed with Waldenström's Macroglobulinemia (WM) with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

   id

   FG000

   title

   Arm A: Ibrutinib

2. description

   Participants diagnosed with WM with mutated MYD88 gene received 160 milligrams (mg) zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

   id

   FG001

   title

   Arm B: Zanubrutinib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      type

      Sponsor's Decision to End the Study

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         14

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         66

      type

      Enrolled in Long-term Extension Study

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant Randomized but died before dosing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         102

      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

         99

      2. group Id

         FG001

         num Subjects

         102

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The screening period consisted of Days -35 to -1.

recruitment Details

A total of 201 participants were randomized to Arm A and Arm B in 12 countries in Australia, Europe, United Kingdom and United States.

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Preserved source evidence · Not medical advice