Participant flow

Palifermin for the Reduction of Oral Mucositis in Patients With Locally Advanced Head and Neck Cancer · Source last updated 2016-09-27

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

groups

1. description

   Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m\^2 cisplatin administered by IV infusion on Days 1, 22, and 43.

   id

   FG000

   title

   Placebo

2. description

   Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m\^2 cisplatin administered by IV infusion on Days 1, 22, and 43.

   id

   FG001

   title

   Palifermin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Ineligibility determined

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         94

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         91

      2. group Id

         FG001

         num Subjects

         94

      type

      Received Study Drug

   3. achievements

      1. comment

         Participants who completed the acute oral mucositis evaluation phase

         group Id

         FG000

         num Subjects

         83

      2. comment

         Participants who completed the acute oral mucositis evaluation phase

         group Id

         FG001

         num Subjects

         79

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         15

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This study was conducted from 03 August 2005 (first participant enrolled) to 11 September 2007 (last participant's last visit at 4 months of follow-up) at 46 study centers in the United States, Canada, and Europe At the time of this report, the long-term safety follow-up period is ongoing.

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

Preserved source evidence · Not medical advice