Participant flow

A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma · Source last updated 2021-04-27

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

groups

1. description

   Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets

   id

   FG000

   title

   Cabozantinib (XL184)

2. description

   Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets

   id

   FG001

   title

   Everolimus (Afinitor)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         32

      2. group Id

         FG001

         num Subjects

         31

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         50

      type

      Clinical Deterioration

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Sponsor Decision

   8. reasons

      1. group Id

         FG000

         num Subjects

         122

      2. group Id

         FG001

         num Subjects

         158

      type

      Progressive Disease

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Reason Not Provided

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         330

      2. group Id

         FG001

         num Subjects

         328

      comment

      Randomized

      type

      STARTED

   2. achievements

      1. comment

         One subject randomized to everolimus arm received cabozantinib discontd due to clin. deterioration

         group Id

         FG000

         num Subjects

         132

      2. comment

         Five subjects were randomized but not treated

         group Id

         FG001

         num Subjects

         73

      comment

      Continuing study treatment at the time of data cut-off

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         198

      2. group Id

         FG001

         num Subjects

         255

      type

      NOT COMPLETED

   title

   Overall Study (ITT)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         20

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         29

      type

      Clinical Deterioration

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lack of Efficacy

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol Violation

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         7

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         82

      2. group Id

         FG001

         num Subjects

         92

      type

      Progressive Disease

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         187

      2. comment

         Three subjects in the everolimus arm were randomized but not treated.

         group Id

         FG001

         num Subjects

         188

      comment

      PITT population consisted of the first 375 subjects randomized to received study treatment.

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         56

      2. group Id

         FG001

         num Subjects

         36

      comment

      Continuing study treatment at the time of data cut-off

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         131

      2. group Id

         FG001

         num Subjects

         152

      type

      NOT COMPLETED

   title

   Primary Intent to Treat (PITT)

recruitment Details

First patient enrolled: 08 August 2013, Data cut off date: 22 May 2015

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

Preserved source evidence · Not medical advice