Participant flow

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors · Source last updated 2015-07-01

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

groups

1. description

   Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).

   id

   FG000

   title

   Everolimus 10 mg/Day

2. description

   Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         98

      2. group Id

         FG001

         num Subjects

         169

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         52

      2. group Id

         FG001

         num Subjects

         18

      type

      Final primary analysis

   3. reasons

      1. group Id

         FG000

         num Subjects

         37

      2. group Id

         FG001

         num Subjects

         7

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         6

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Abnormal test result (s)

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   8. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         207

      2. group Id

         FG001

         num Subjects

         203

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         204

      2. group Id

         FG001

         num Subjects

         203

      type

      Safety Population

   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

         207

      2. group Id

         FG001

         num Subjects

         203

      type

      NOT COMPLETED

   title

   Double-blind Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         124

      2. group Id

         FG001

         num Subjects

         0

      type

      Disease Progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         46

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         17

      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

         0

      type

      Death

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         0

      type

      New cancer therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Protocol Violation

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Abnormal laboratory value (s)

   milestones

   1. achievements

      1. comment

         172 patients switched over from placebo \& 53 who were initially randomized to Everolimus arm.

         group Id

         FG000

         num Subjects

         225

      2. group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         225

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Open-label Period

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Preserved source evidence · Not medical advice