Participant flow

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole · Source last updated 2017-05-02

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

groups

1. description

   Everolimus 10 mg daily in combination with exemestane 25 mg daily

   id

   FG000

   title

   Everolimus + Exemestane

2. description

   Placebo of everolimus in combination with exemestane 25 mg daily

   id

   FG001

   title

   Placebo + Exemestane

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   2. reasons

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         8

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         47

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Administrative problems

   5. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      New cancer therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         364

      2. group Id

         FG001

         num Subjects

         221

      type

      Disease progression

   8. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         1

      type

      Treatment completed as per protocol

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         485

      2. group Id

         FG001

         num Subjects

         239

      type

      STARTED

   2. achievements

      1. comment

         Completed means discontinued the treatment period.

         group Id

         FG000

         num Subjects

         0

      2. comment

         Completed means discontinued the treatment period.

         group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         485

      2. group Id

         FG001

         num Subjects

         239

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Although 724 patients were randomized, 4 never received any study treatment and thus were excluded form the safety set.

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

Preserved source evidence · Not medical advice