Participant flow

A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma · Source last updated 2015-03-30

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

groups

1. description

   Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.

   id

   FG000

   title

   Palifermin Before Only

2. description

   Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.

   id

   FG001

   title

   Placebo

3. description

   Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy

   id

   FG002

   title

   Palifermin Before and After

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Non-Compliance

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      type

      Withdrawal by Subject

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         3

      type

      Logistical error study assessments

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         109

      2. group Id

         FG001

         num Subjects

         57

      3. group Id

         FG002

         num Subjects

         115

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         99

      2. group Id

         FG001

         num Subjects

         54

      3. group Id

         FG002

         num Subjects

         104

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice