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NCT01524783 · OUTCOME

All Collected Deaths

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.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
On-treatment deaths: up to approximately 8 years. All deaths: up to approximately 8 years

What was measured

Deaths on-treatment were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 8 years. Total Deaths were collected from first dose of study treatment until end of post-treatment survival follow, up to maximum duration of approximately 8 years.

Analysis population: The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set

Groups in this outcome

Everolimus + BSC (Throughout the Study)

Participants received everolimus 10 mg once daily BSC throughout the study

Everolimus +BSC (Crossover)

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

Everolimus+BSC (All)

All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)

Placebo + BSC (Blinded Period)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Everolimus + BSC (Throughout the Study)202
Everolimus +BSC (Crossover)6
Everolimus+BSC (All)208
Placebo + BSC (Blinded Period)98

Reported measurements

On-treatment deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus + BSC (Throughout the Study)10Not reportedNot reportedNot reportedNot reported
Everolimus +BSC (Crossover)0Not reportedNot reportedNot reportedNot reported
Everolimus+BSC (All)10Not reportedNot reportedNot reportedNot reported
Placebo + BSC (Blinded Period)5Not reportedNot reportedNot reportedNot reported
Total deaths
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus + BSC (Throughout the Study)126Not reportedNot reportedNot reportedNot reported
Everolimus +BSC (Crossover)1Not reportedNot reportedNot reportedNot reported
Everolimus+BSC (All)127Not reportedNot reportedNot reportedNot reported
Placebo + BSC (Blinded Period)57Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        5
    title
    On-treatment deaths
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        126
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        127
      4. group Id
        OG003
        value
        57
    title
    Total deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      202
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      208
    4. group Id
      OG003
      value
      98
    units
    Participants
description
Deaths on-treatment were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 8 years. Total Deaths were collected from first dose of study treatment until end of post-treatment survival follow, up to maximum duration of approximately 8 years.
groups
  1. description
    Participants received everolimus 10 mg once daily BSC throughout the study
    id
    OG000
    title
    Everolimus + BSC (Throughout the Study)
  2. description
    Participants who crossed over from placebo arm (blinded period) to open-label treatment with everolimus 10mg once daily plus BSC
    id
    OG001
    title
    Everolimus +BSC (Crossover)
  3. description
    All participants who received everolimus 10 mg once daily plus BSC (including those who received everolimus+BSC from start to end of the study and those who received everolimus+BSC after crossover)
    id
    OG002
    title
    Everolimus+BSC (All)
  4. description
    Participants received matching placebo once daily plus BSC during the blinded period
    id
    OG003
    title
    Placebo + BSC (Blinded Period)
param Type
NUMBER
population Description
The safety set consists of all participants who received at least one dose of the study drug and had at least one post-baseline safety evaluation. Participants were analyzed according to treatment actually received: One participant randomized to everolimus arm received only placebo and therefore, appears in the placebo arm in the safety set
reporting Status
POSTED
time Frame
On-treatment deaths: up to approximately 8 years. All deaths: up to approximately 8 years
title
All Collected Deaths
type
POST_HOC
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice