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NCT00510068 · OUTCOME

Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%

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
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010

What was measured

The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, \> 2% to less than or equal to 5% and \> 5%.

Analysis population: The Full Analysis Set (FAS) consisted of all patients who were randomized.

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

Ki67 <=2% (n: 7, 17)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day12.52Not reported3.4214.75Not reported
Placebo3.68Not reported2.865.52Not reported
2% <Ki67 <=5% (n: 24, 13)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day10.94Not reported5.5516.59Not reported
Placebo8.48Not reported3.7813.83Not reported
Ki67 >5% (n: 20, 22)
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day7.69Not reported5.59NAUpper boundary of the 95% (Confidence Interval (CI) was not computable
Placebo3.15Not reported2.795.55Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.42
        upper Limit
        14.75
        value
        12.52
      2. group Id
        OG001
        lower Limit
        2.86
        upper Limit
        5.52
        value
        3.68
    title
    Ki67 <=2% (n: 7, 17)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.55
        upper Limit
        16.59
        value
        10.94
      2. group Id
        OG001
        lower Limit
        3.78
        upper Limit
        13.83
        value
        8.48
    title
    2% <Ki67 <=5% (n: 24, 13)
  3. categories
    1. measurements
      1. comment
        Upper boundary of the 95% (Confidence Interval (CI) was not computable
        group Id
        OG000
        lower Limit
        5.59
        upper Limit
        NA
        value
        7.69
      2. group Id
        OG001
        lower Limit
        2.79
        upper Limit
        5.55
        value
        3.15
    title
    Ki67 >5% (n: 20, 22)
denoms
  1. counts
    1. group Id
      OG000
      value
      207
    2. group Id
      OG001
      value
      203
    units
    Participants
description
The level of Ki 67 expression for evaluable tumor samples were analyzed towards progression free survival (PFS) as per local investigator assessment. The Ki-67 protein is a cellular marker for proliferation. It is strictly associated with cell proliferation. During interphase, the Ki-67 antigen can be exclusively detected within the cell nucleus, whereas in mitosis most of the protein is relocated to the surface of the chromosomes. Baseline Ki 67 levels were categorized as: less than or equal to 2%, \> 2% to less than or equal to 5% and \> 5%.
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) consisted of all patients who were randomized.
reporting Status
POSTED
time Frame
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
title
Progression Free Survival According to Ki-67 Levels Categorized as: Less Than or Equal to 2%, > 2% to Less Than or Equal to 5% and > 5%
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice