Participant flow

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2013-09-18

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

groups

1. description

   Pemetrexed 500 milligram per meter squared (mg/m\^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

   id

   FG000

   title

   Pemetrexed + Cisplatin + Cetuximab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         35

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         10

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Sponsor Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         8

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         66

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         66

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice