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Ruxolitinib Efficacy and Safety in Patients With HU Resistant or Intolerant Polycythemia Vera vs Best Available Therapy. · Source last updated 2021-07-20

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

groups

1. description

   Ruxolitinib at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid

   id

   FG000

   title

   Ruxolitinib

2. description

   Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib

   id

   FG001

   title

   Best Available Therapy (BAT)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Disease progression

   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

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Subject/guardian decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         75

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         75

      comment

      comprised of all patients to whom study treatment was assigned by randomization.

      type

      Full Analysis Set

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         58

      comment

      consisted of all patients randomized to the BAT arm, who crossed over and received at least one dose of ruxolitinib.

      type

      Crossover Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         59

      2. group Id

         FG001

         num Subjects

         61

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         14

      type

      NOT COMPLETED

   title

   Core Study

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         9

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Disease progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. comment

         58 participants were eligible to crossover to the ruxolitinib arm

         group Id

         FG001

         num Subjects

         58

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         38

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         20

      type

      NOT COMPLETED

   title

   Crossover Period

pre Assignment Details

Participants were randomized in a 1:1 ratio either to Ruxolitinib or Best available Therapy (BAT). Randomization was stratified by patients who were resistant to or intolerant of Hydroxyurea (HU).

recruitment Details

Participants were randomized in 48 centers across 12 countries: Australia (1), Belgium (2), Canada (1), France (7), Germany (9), Hungary (3), India (2), Israel (3), Italy (7), South Korea (2), Spain (9) and Turkey (2)

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Preserved source evidence · Not medical advice