Participant flow

A Study in Second Line Metastatic Colorectal Cancer · Source last updated 2019-09-25

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

groups

1. description

   On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.

   id

   FG000

   title

   Ramucirumab + FOLFIRI

2. description

   On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. Placebo: Administered intravenously. Irinotecan: 180 mg/m\^2 administered intravenously. Folinic Acid: 400 mg/m\^2 administered intravenously. 5-Fluorouracil: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion.

   id

   FG001

   title

   Placebo + FOLFIRI

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         536

      2. group Id

         FG001

         num Subjects

         536

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         528

      2. group Id

         FG001

         num Subjects

         529

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         505

      2. group Id

         FG001

         num Subjects

         511

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         25

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Completers included participants who died from any cause and participants who were alive and on study at conclusion however were off treatment.

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