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NCT00510068 · OUTCOME

Overall Survival

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.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline, to death- no time limit

What was measured

Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.

Analysis population: The Full Analysis Set (FAS) included all randomized patients.

Groups in this outcome

Everolimus 10 mg/Day

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).

Placebo

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).

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 10 mg/Day207
Placebo203

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day44.02Not reported35.6151.75Not reported
Placebo37.68Not reported29.1445.77Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.61
        upper Limit
        51.75
        value
        44.02
      2. group Id
        OG001
        lower Limit
        29.14
        upper Limit
        45.77
        value
        37.68
denoms
  1. counts
    1. group Id
      OG000
      value
      207
    2. group Id
      OG001
      value
      203
    units
    Participants
description
Overall survival (OS) was defined as the time from date of randomization to the date of death due to any cause. Analyses were performed using all deaths in the FAS population regardless of whether they were observed during the double-blind treatment period, the open-label treatment period, the post-treatment evaluations, or the survival follow-up period.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
The Full Analysis Set (FAS) included all randomized patients.
reporting Status
POSTED
time Frame
Baseline, to death- no time limit
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice