Participant flow

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.

   id

   FG000

   title

   Panitumumab Plus FOLFIRI

2. description

   Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.

   id

   FG001

   title

   FOLFIRI Alone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         19

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         17

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         8

      type

      Protocol-specified criteria

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Missing reason

   7. reasons

      1. group Id

         FG000

         num Subjects

         46

      2. group Id

         FG001

         num Subjects

         40

      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

         591

      2. group Id

         FG001

         num Subjects

         595

      type

      STARTED

   2. achievements

      1. comment

         Includes one participant who received FOLFIRI Alone

         group Id

         FG000

         num Subjects

         588

      2. group Id

         FG001

         num Subjects

         593

      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

         470

      2. comment

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

         group Id

         FG001

         num Subjects

         490

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         121

      2. group Id

         FG001

         num Subjects

         105

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

First patient enrolled 30 June 2006; Last patient enrolled 13 March 2008.

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