Participant flow

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) · Source last updated 2022-10-05

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

groups

1. description

   Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.

   id

   FG000

   title

   Nivolumab 3mg/kg

2. description

   Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice

   id

   FG001

   title

   Investigators Choice

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant request to discontinue study treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      type

      Participant withdrew consent

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      type

      Participant no longer meets study criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         240

      2. group Id

         FG001

         num Subjects

         121

      comment

      Started = Randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         236

      2. group Id

         FG001

         num Subjects

         111

      comment

      Completed = Entering treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Pre-Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         10

      type

      Study Drug Toxicity

   2. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         3

      type

      Adverse event unrelated to study drug

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      type

      Participant request to discontinue study treatment

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant withdrew consent

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         3

      type

      Maximum Clinical Benefit

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Poor/Non-compliance

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant no longer meets study criteria

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Other reasons

   10. reasons

       1. group Id

          FG000

          num Subjects

          185

       2. group Id

          FG001

          num Subjects

          87

       type

       Disease Progression

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         236

      2. group Id

         FG001

         num Subjects

         111

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         235

      2. group Id

         FG001

         num Subjects

         111

      type

      NOT COMPLETED

   title

   Treatment

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Preserved source evidence · Not medical advice