Participant flow

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1)) · Source last updated 2015-05-21

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

groups

1. description

   Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).

   id

   FG000

   title

   Vorinostat 200 mg + Bortezomib 0.7 mg/m^2

2. description

   Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).

   id

   FG001

   title

   Vorinostat 200 mg + Bortezomib 0.9 mg/m^2

3. description

   Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

   id

   FG002

   title

   Vorinostat 300 mg + Bortezomib 1.3 mg/m^2

4. description

   Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

   id

   FG003

   title

   Vorinostat 400 mg + Bortezomib 0.9 mg/m^2

5. description

   Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

   id

   FG004

   title

   Vorinostat 400 mg + Bortezomib 1.1 mg/m^2

6. description

   Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

   id

   FG005

   title

   Vorinostat 400 mg + Bortezomib 1.3 mg/m^2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         3

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         10

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice