Participant flow

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

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

groups

1. description

   Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

   id

   FG000

   title

   Placebo/FOLFIRI

2. description

   Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

   id

   FG001

   title

   Aflibercept/FOLFIRI

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         74

      2. group Id

         FG001

         num Subjects

         163

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         437

      2. group Id

         FG001

         num Subjects

         305

      type

      Disease progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      type

      poor 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

         21

      2. group Id

         FG001

         num Subjects

         20

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      type

      Consent Withdrawn

   7. reasons

      1. group Id

         FG000

         num Subjects

         43

      2. group Id

         FG001

         num Subjects

         77

      type

      Subject request

   8. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         12

      type

      Metastatic surgery

   9. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Unauthorized procedure

   10. reasons

       1. group Id

          FG000

          num Subjects

          5

       2. group Id

          FG001

          num Subjects

          5

       type

       Randomized but not treated

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          4

       type

       Missed visit window

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          1

       type

       Planning surgery

   Show more (12 of 13)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         614

      2. group Id

         FG001

         num Subjects

         612

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         609

      2. group Id

         FG001

         num Subjects

         607

      type

      TREATED

   3. achievements

      1. comment

         Treated participants excluding 4 who received at least 1 dose of Aflibercept

         group Id

         FG000

         num Subjects

         605

      2. comment

         Treated participants including 4 from Placebo/FOLFIRI who received at least 1 dose of Aflibercept

         group Id

         FG001

         num Subjects

         611

      type

      SAFETY POPULATION

   4. achievements

      1. comment

         Participants continuing treatment on the cutoff date of the final analysis

         group Id

         FG000

         num Subjects

         11

      2. comment

         Participants continuing treatment on the cutoff date of the final analysis

         group Id

         FG001

         num Subjects

         14

      type

      ONGOING TREATMENT

   5. achievements

      1. comment

         Participants met treatment discontinuation criteria or were ongoing treatment on the cutoff date

         group Id

         FG000

         num Subjects

         0

      2. comment

         Participants met treatment discontinuation criteria or were ongoing treatment on the cutoff date

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         614

      2. group Id

         FG001

         num Subjects

         612

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Between 19 November 2007 and 16 March 2010, 614 participants were randomized to the placebo arm and 612 participants were randomized to the aflibercept arm.

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Preserved source evidence · Not medical advice