Participant flow

PRIME: Panitumumab Randomized Trial In Combination With Chemotherapy for Metastatic Colorectal Cancer to Determine Efficacy · Source last updated 2022-11-07

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

groups

1. description

   Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.

   id

   FG000

   title

   FOLFOX + Panitumumab

2. description

   Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.

   id

   FG001

   title

   FOLFOX Alone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Ineligibility determined

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         18

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         3

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      type

      Protocol-specified criteria

   7. reasons

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         47

      type

      Other

   8. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         13

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         593

      2. group Id

         FG001

         num Subjects

         590

      type

      STARTED

   2. achievements

      1. comment

         One participant randomized to this group did not receive any panitumumab

         group Id

         FG000

         num Subjects

         586

      2. group Id

         FG001

         num Subjects

         583

      type

      Received Study Drug

   3. achievements

      1. comment

         Indicates participants who had completed the safety visit 30 days after last dose or had died

         group Id

         FG000

         num Subjects

         492

      2. comment

         Indicates participants who had completed the safety visit 30 days after last dose or had died

         group Id

         FG001

         num Subjects

         495

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         101

      2. group Id

         FG001

         num Subjects

         95

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

First patient enrolled 23 August 2006 and last patient enrolled 01 February 2008. Participant flow data are reported as of the data cut-off date of 28 August 2009.

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

Preserved source evidence · Independent clinical review pending · Not medical advice