Participant flow

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) · Source last updated 2021-08-05

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

groups

1. description

   Participants received everolimus 10 mg once daily BSC throughout the study

   id

   FG000

   title

   Everolimus + BSC (Throughout Study)

2. description

   Participants received matching placebo once daily plus BSC during the blinded period

   id

   FG001

   title

   Placebo+BSC (Blinded Period)

3. description

   Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC

   id

   FG002

   title

   Everolimus+BSC (Crossover)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         64

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         89

      2. group Id

         FG001

         num Subjects

         75

      3. group Id

         FG002

         num Subjects

         0

      type

      Disease Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         19

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol deviation

   5. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         205

      2. group Id

         FG001

         num Subjects

         97

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         0

      comment

      Participants who entered the open-label part of the study

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         179

      2. group Id

         FG001

         num Subjects

         91

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Blinded Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         2

      type

      Administrative problems

   3. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol deviation

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Open-label Period

pre Assignment Details

At baseline, participants were randomized to either everolimus+BSC or placebo+BSC arm. Two patients randomized to the everolimus arm were not treated due to withdrawal of consent and protocol deviation. As per Data Monitoring Committee recommendation (03-Jun-2015), implemented through protocol amendment 3 (issued on 06-May-2016), remaining participants entered the open-label part of the study, where participants in the placebo arm were allowed to crossover to open-label treatment with everolimus

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Preserved source evidence · Not medical advice