Participant flow

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer · Source last updated 2016-06-22

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

groups

1. description

   Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).

   id

   FG000

   title

   Capecitabine

2. description

   Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).

   id

   FG001

   title

   5-Fluorouracil + Leucovorin

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         112

      2. group Id

         FG001

         num Subjects

         75

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         17

      2. group Id

         FG001

         num Subjects

         15

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         9

      type

      Violation of Selection Criteria at Entry

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Other Protocol Violation

   6. reasons

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         16

      type

      Refused Treatment

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         1

      type

      Administrative/Other Reasons

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         1004

      2. group Id

         FG001

         num Subjects

         983

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         834

      2. group Id

         FG001

         num Subjects

         860

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         170

      2. group Id

         FG001

         num Subjects

         123

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

A total of 1987 participants were recruited into the study across 164 centers in 25 countries. This study was conducted from 12 Nov 1998 to 01 Apr 2004.

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Preserved source evidence · Not medical advice