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NCT00510068 · OUTCOME

Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)

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
MEAN
Unit
pg/mL
Interval / dispersion
Standard Deviation
Time frame
Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1

What was measured

This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.

Analysis population: The Full Analysis Set (FAS) consists 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

Baseline (n:198, 195)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day52.59101.659Not reportedNot reportedNot reported
Placebo51.4978.049Not reportedNot reportedNot reported
Cycle 2 Day 1 (n: 185, 184)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day38.4351.809Not reportedNot reportedNot reported
Placebo58.3372.938Not reportedNot reportedNot reported
Cycle 3 Day 1 (n: 185, 174)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day51.9789.064Not reportedNot reportedNot reported
Placebo59.0872.495Not reportedNot reportedNot reported
Cycle 4 Day 1 (n: 171, 159)
Values in pg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Everolimus 10 mg/Day51.2882.139Not reportedNot reportedNot reported
Placebo54.5875.350Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        101.659
        value
        52.59
      2. group Id
        OG001
        spread
        78.049
        value
        51.49
    title
    Baseline (n:198, 195)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.809
        value
        38.43
      2. group Id
        OG001
        spread
        72.938
        value
        58.33
    title
    Cycle 2 Day 1 (n: 185, 184)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.064
        value
        51.97
      2. group Id
        OG001
        spread
        72.495
        value
        59.08
    title
    Cycle 3 Day 1 (n: 185, 174)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.139
        value
        51.28
      2. group Id
        OG001
        spread
        75.350
        value
        54.58
    title
    Cycle 4 Day 1 (n: 171, 159)
denoms
  1. counts
    1. group Id
      OG000
      value
      207
    2. group Id
      OG001
      value
      203
    units
    Participants
description
This biomarker is related to angiogenesis pathway, was analyzed to determine the effects of everolimus on plasma antiangiogenic molecules.
dispersion Type
Standard Deviation
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
MEAN
population Description
The Full Analysis Set (FAS) consists of all patients who were randomized.
reporting Status
POSTED
time Frame
Baseline, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1
title
Plasma Angiogenesis Marker: Basic Fibroblast Growth Factor (bFGF)
type
SECONDARY
unit Of Measure
pg/mL

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

Preserved source evidence · Not medical advice