Participant flow

A Trial of Romidepsin for Progressive or Relapsed Peripheral T-cell Lymphoma · Source last updated 2020-02-11

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

groups

1. description

   Participants received romidepsin 14 mg/m\^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.

   id

   FG000

   title

   Romidepsin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Compassionate Use

   5. reasons

      1. group Id

         FG000

         num Subjects

         83

      type

      Progressive Disease

   6. reasons

      1. group Id

         FG000

         num Subjects

         24

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   9. reasons

      1. group Id

         FG000

         num Subjects

         10

      type

      Other Reasons (Miscellaneous)

   milestones

   1. achievements

      1. comment

         Represents the number of patients who received any amount of study drug.

         group Id

         FG000

         num Subjects

         131

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         98

      type

      Discontinued Prior to or During Cycle 6

   3. achievements

      1. group Id

         FG000

         num Subjects

         33

      type

      Discontinued at End of or After Cycle 6

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         131

      type

      NOT COMPLETED

   title

   Overall Study

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice