Participant flow

Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer · Source last updated 2016-04-19

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

groups

1. description

   2.5 mg by mouth (p.o.) once daily

   id

   FG000

   title

   Letrozole

2. description

   1 mg p.o. once daily

   id

   FG001

   title

   Anastrozole

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         71

      2. group Id

         FG001

         num Subjects

         79

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         30

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         35

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         216

      type

      Disease progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         47

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         311

      2. group Id

         FG001

         num Subjects

         296

      type

      Adverse Event

   7. reasons

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         25

      type

      Administrative problems

   8. reasons

      1. group Id

         FG000

         num Subjects

         49

      2. group Id

         FG001

         num Subjects

         61

      type

      Abnormal test procedure(s) result

   9. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Abnormal laboratory values

   10. reasons

       1. group Id

          FG000

          num Subjects

          17

       2. group Id

          FG001

          num Subjects

          19

       type

       Protocol deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         2078

      2. group Id

         FG001

         num Subjects

         2094

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2061

      2. group Id

         FG001

         num Subjects

         2075

      type

      Intent-to-treat (ITT)

   3. achievements

      1. group Id

         FG000

         num Subjects

         2049

      2. group Id

         FG001

         num Subjects

         2062

      type

      Safety Set

   4. achievements

      1. group Id

         FG000

         num Subjects

         1317

      2. group Id

         FG001

         num Subjects

         1286

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         761

      2. group Id

         FG001

         num Subjects

         808

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Participants, who had recently undergone surgery, were randomly assigned in 1:1 ratio to letrozole or anastrozole. Participants received daily treatment until disease recurrence/relapse or for a maximum of 5 years. Participants underwent post-treatment long term follow-up for disease-free survival and overall survival.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice