Participant flow

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · 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 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously. * Docetaxel: 75 milligrams per square meter (mg/m\^2) (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

   id

   FG000

   title

   Ramucirumab and Docetaxel

2. description

   On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.

   id

   FG001

   title

   Placebo and Docetaxel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         341

      2. group Id

         FG001

         num Subjects

         429

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         94

      2. group Id

         FG001

         num Subjects

         55

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         90

      2. group Id

         FG001

         num Subjects

         53

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         42

      2. group Id

         FG001

         num Subjects

         45

      type

      Death

   5. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         19

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Sponsor Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         9

      type

      Protocol Criterion Not Met and Deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         628

      2. group Id

         FG001

         num Subjects

         625

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         624

      2. comment

         Three participants randomized to placebo and docetaxel received 1 dose of ramucirumab in error.

         group Id

         FG001

         num Subjects

         621

      type

      Received Any Quantity of Any Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         14

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         613

      2. group Id

         FG001

         num Subjects

         611

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants who died, due to any cause, or were alive at the end of the study but off study drug were considered to have completed the study.

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Preserved source evidence · Not medical advice