Participant flow

XRP6258 Plus Prednisone Compared to Mitoxantrone Plus Prednisone in Hormone Refractory Metastatic Prostate Cancer · Source last updated 2011-03-10

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

groups

1. description

   mitoxantrone 12 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

   id

   FG000

   title

   Mitoxantrone + Prednisone

2. description

   cabazitaxel 25 mg/m\^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily

   id

   FG001

   title

   Cabazitaxel + Prednisone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         267

      2. group Id

         FG001

         num Subjects

         180

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         67

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-compliance to protocol

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         8

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         7

      type

      Not treated

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Screened failure

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      type

      Investigator's decision

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Non-confirmed Disease progression

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Clinical deterioration

   11. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          1

       type

       Screening error

   12. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Withdrawal by subject's family

   Show more (12 of 14)

   milestones

   1. achievements

      1. comment

         Randomized patients

         group Id

         FG000

         num Subjects

         377

      2. comment

         Randomized patients

         group Id

         FG001

         num Subjects

         378

      type

      STARTED

   2. achievements

      1. comment

         Randomized patients

         group Id

         FG000

         num Subjects

         46

      2. comment

         Randomized patients

         group Id

         FG001

         num Subjects

         105

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         331

      2. group Id

         FG001

         num Subjects

         273

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

165 patients signed informed consent but were not randomized and considered as screen failure. Intention to Treat Population (ITT or randomized patients): 755 patients (377 mitoxantrone, 378 cabazitaxel). Safety population (treated patients): 742 patients (371 mitoxantrone, 371 cabazitaxel) (Patients not treated: 6 mitoxantrone, 7 cabazitaxel).

recruitment Details

Multicenter study: 146 actives sites from 26 countries in Europe, USA, South America and Asia Pacific region. Study initiation date: January 2nd, 2007; study completion date/study cut off date: September 25th, 2009.

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Preserved source evidence · Not medical advice