Participant flow

Erlotinib in Women With Squamous Cell Carcinoma of the Vulvar · Source last updated 2015-05-07

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

groups

1. description

   Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.

   id

   FG000

   title

   Erlotinib-Cohort 1

2. description

   Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.

   id

   FG001

   title

   Erlotinib-Cohort 2

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         17

      type

      Progressive Disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         24

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         17

      2. comment

         One woman was unevaluable due to an allergic reaction that developed after the 2nd dose.

         group Id

         FG001

         num Subjects

         23

      type

      Response Evaluable

   3. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. comment

         Treatment was not of fixed duration and thus pts are not considered to have 'Completed' treatment.

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         24

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Patients enrolled from February 2007 through July 2011.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice