Participant flow

A Study of Intermittent, High-dose Afatinib to Determine the Maximal Tolerated Dose and Assess Activity of This Dose Against Non-small Cell Lung Cancer With T790M Mutations · Source last updated 2017-01-31

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

groups

1. description

   Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

   id

   FG000

   title

   Afatinib 90mg

2. description

   Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

   id

   FG001

   title

   Afatinib 120mg

3. description

   Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

   id

   FG002

   title

   Afatinib 150mg

4. description

   Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

   id

   FG003

   title

   Afatinib 160mg

5. description

   Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.

   id

   FG004

   title

   Afatinib 200mg

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         8

      5. group Id

         FG004

         num Subjects

         2

      type

      Progressive disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      type

      Other adverse event

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         1

      type

      Refused to continue taking medication

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      type

      Other reason not defined

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         9

      4. group Id

         FG003

         num Subjects

         11

      5. group Id

         FG004

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Afatinib was administered until disease progression, however patients experiencing clinical benefit were allowed to continue treatment for as long as judged beneficial by the investigator.

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Preserved source evidence · Not medical advice