Participant flow

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) · Source last updated 2023-09-21

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

groups

1. description

   Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.

   id

   FG000

   title

   Duvelisib

2. description

   Ofatumumab is administered as an intravenous (IV) infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.

   id

   FG001

   title

   Ofatumumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         55

      2. group Id

         FG001

         num Subjects

         6

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Other is reason listed by PI

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Never Dosed

   8. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         31

      type

      Disease Progression

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         103

      type

      Completed Treatment Cycles Per Protocol

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         160

      2. group Id

         FG001

         num Subjects

         159

      comment

      Number of subjects randomized.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         158

      2. group Id

         FG001

         num Subjects

         155

      comment

      Number of subjects exposed to treatment.

      type

      Number of Subjects Treated

   3. achievements

      1. comment

         Completed defined here as still on treatment.

         group Id

         FG000

         num Subjects

         34

      2. comment

         Completed defined here as still on treatment.

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         126

      2. group Id

         FG001

         num Subjects

         159

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice