Participant flow

Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer · Source last updated 2018-09-13

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

groups

1. description

   Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.

   id

   FG000

   title

   DB Sorafenib First, Then Option of OL Sorafenib Treatment

2. description

   Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.

   id

   FG001

   title

   DB Placebo First, Then Option of OL Sorafenib Treatment

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         6

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         3

      type

      Progression, recurrence or relapse

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Noncompliance with study medication

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Progression by clinical judgment

   6. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         18

      type

      Withdrawal by Subject

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         4

      type

      Death

   9. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Not treated

   10. reasons

       1. group Id

          FG000

          num Subjects

          6

       2. group Id

          FG001

          num Subjects

          1

       type

       Switched to commercial drug

   11. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          1

       type

       protocol driven decision point

   12. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Radiological and clinical progression

   Show more (12 of 13)

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         207

      2. group Id

         FG001

         num Subjects

         210

      type

      STARTED

   2. achievements

      1. comment

         Subjects at Risk/Safety Population - in RG1 (RG= Reporting Group for Safety Data)

         group Id

         FG000

         num Subjects

         207

      2. comment

         Subjects at Risk/Safety Population - in RG2 (RG= Reporting Group for Safety Data)

         group Id

         FG001

         num Subjects

         209

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         103

      2. group Id

         FG001

         num Subjects

         172

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         104

      2. group Id

         FG001

         num Subjects

         38

      type

      NOT COMPLETED

   title

   Double Blind Treatment

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         30

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         21

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         15

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         82

      type

      Progression, recurrence or relapse

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Patient convenience

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliant with study medication

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Target lesion removed

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Protocol driven decision point

   10. reasons

       1. group Id

          FG000

          num Subjects

          2

       2. group Id

          FG001

          num Subjects

          3

       type

       Transferred to treat. continuation study

   11. reasons

       1. group Id

          FG000

          num Subjects

          6

       2. group Id

          FG001

          num Subjects

          7

       type

       Switched to commercial drug

   12. reasons

       1. group Id

          FG000

          num Subjects

          1

       2. group Id

          FG001

          num Subjects

          0

       type

       Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         86

      2. group Id

         FG001

         num Subjects

         161

      type

      STARTED

   2. achievements

      1. comment

         Subjects at Risk/Safety Population - in RG3 (RG= Reporting Group for Safety Data)

         group Id

         FG000

         num Subjects

         86

      2. comment

         Subjects at Risk/Safety Population - in RG4 (RG= Reporting Group for Safety Data)

         group Id

         FG001

         num Subjects

         161

      type

      Received Treatment

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         86

      2. group Id

         FG001

         num Subjects

         161

      type

      NOT COMPLETED

   title

   Open-label Treatment

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         27

      2. group Id

         FG001

         num Subjects

         68

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         6

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         26

      type

      Protocol driven decision point

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      type

      Transferred to treat. continuation study

   6. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      type

      Switched to commercial drug

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Disease prog., recurrence or relapse

   milestones

   1. achievements

      1. comment

         Participants entered long-term follow-up if terminated double-blind or open-label periods

         group Id

         FG000

         num Subjects

         72

      2. comment

         Participants entered long-term follow-up if terminated double-blind or open-label periods

         group Id

         FG001

         num Subjects

         124

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         69

      2. group Id

         FG001

         num Subjects

         120

      type

      NOT COMPLETED

   title

   Long Term Follow-up

pre Assignment Details

Of 556 screened participants, 137 failed screening, 207 were randomized to receive sorafenib, 210 were randomized to placebo.

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Preserved source evidence · Not medical advice