Participant flow

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2014-12-29

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

groups

1. description

   Pemetrexed: 500 milligrams per square meter (mg/m\^2), intravenous (IV) administration, every (q) 21 days, until disease progression. Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

   id

   FG000

   title

   Pemetrexed and BSC

2. description

   Placebo: IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

   id

   FG001

   title

   Placebo and BSC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         307

      2. group Id

         FG001

         num Subjects

         196

      type

      Progressive Disease (PD)

   2. reasons

      1. group Id

         FG000

         num Subjects

         46

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         24

      2. group Id

         FG001

         num Subjects

         6

      type

      Physician Decision

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Enrollment Criteria Not Met

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   9. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Satisfactory Response

   10. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Sponsor Decision

   11. reasons

       1. group Id

          FG000

          num Subjects

          7

       2. group Id

          FG001

          num Subjects

          2

       type

       Alive, Receiving Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         441

      2. group Id

         FG001

         num Subjects

         222

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         434

      2. comment

         Four participants randomized to placebo received pemetrexed.

         group Id

         FG001

         num Subjects

         222

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         441

      2. group Id

         FG001

         num Subjects

         222

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants who signed the informed consent form (ICF) and completed the randomized process are presented in the participant flow by the treatment arm to which they were randomized. Participants who did not sign the ICF or complete the randomization process were removed from the database and excluded from all analyses.

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

Preserved source evidence · Not medical advice