Participant flow

Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial) · Source last updated 2019-03-06

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

groups

1. description

   Starting dose of 10 mg twice a day (BID) with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy

   id

   FG000

   title

   Ruxolitinib

2. description

   Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.

   id

   FG001

   title

   Best Available Therapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         13

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         11

      type

      Disease progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol deviation

   6. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         15

      type

      Participant decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliance with study treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         110

      2. comment

         One participant withdrew consent 5 days after randomization to BAT \& wasn't treated while on study.

         group Id

         FG001

         num Subjects

         112

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         110

      2. group Id

         FG001

         num Subjects

         111

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         21

      type

      Followed for Survival

   4. achievements

      1. group Id

         FG000

         num Subjects

         65

      2. comment

         Study evaluation completion is reported for participants that were treated \& those never treatment.

         group Id

         FG001

         num Subjects

         61

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         45

      2. group Id

         FG001

         num Subjects

         51

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants may be treated beyond 256 weeks due to the 14 day visit window.

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

Preserved source evidence · Not medical advice