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NCT00667342 · OUTCOME

Mean Ve

A Study of Bevacizumab in Combination With Chemotherapy for Treatment of Osteosarcoma · Source last updated 2023-08-07

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

Measure
MEAN
Unit
(unitless)
Interval / dispersion
Standard Deviation
Time frame
Baseline through Week 10

What was measured

The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.

Analysis population: The number analyzed at each time point differed due to missing observations at some of the time points

Groups in this outcome

A: Localized Resectable Disease

Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.

C: Metastatic Tumors

Stratum C participants had metastatic tumors.

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

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease31
C: Metastatic Tumors11

Reported measurements

Baseline

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease26
C: Metastatic Tumors9
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.25430.0785Not reportedNot reportedNot reported
C: Metastatic Tumors0.26710.0888Not reportedNot reportedNot reported
Day -2

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease21
C: Metastatic Tumors6
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.24440.0871Not reportedNot reportedNot reported
C: Metastatic Tumors0.26230.0781Not reportedNot reportedNot reported
Day 1

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease21
C: Metastatic Tumors6
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.25640.1209Not reportedNot reportedNot reported
C: Metastatic Tumors0.26020.0447Not reportedNot reportedNot reported
Day 5

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease24
C: Metastatic Tumors8
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.28540.1138Not reportedNot reportedNot reported
C: Metastatic Tumors0.31260.0727Not reportedNot reportedNot reported
Week 5

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease28
C: Metastatic Tumors11
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.30550.1622Not reportedNot reportedNot reported
C: Metastatic Tumors0.31050.1425Not reportedNot reportedNot reported
Week 10

Analysis denominator · Participants

GroupSource count
A: Localized Resectable Disease27
C: Metastatic Tumors11
Values in (unitless) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
A: Localized Resectable Disease0.27760.1225Not reportedNot reportedNot reported
C: Metastatic Tumors0.27260.1596Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    The association between response and Ve at Week 10 was evaluated.
    non Inferiority Type
    OTHER
    p Value
    0.0863
    statistical Method
    Logistic Regression
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    The association between response and Ve at Week 10 was evaluated.
    non Inferiority Type
    OTHER
    p Value
    0.0863
    statistical Method
    Logistic Regression
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0785
        value
        0.2543
      2. group Id
        OG001
        spread
        0.0888
        value
        0.2671
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        9
      units
      Participants
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.0871
        value
        0.2444
      2. group Id
        OG001
        spread
        0.0781
        value
        0.2623
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Day -2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1209
        value
        0.2564
      2. group Id
        OG001
        spread
        0.0447
        value
        0.2602
    denoms
    1. counts
      1. group Id
        OG000
        value
        21
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1138
        value
        0.2854
      2. group Id
        OG001
        spread
        0.0727
        value
        0.3126
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      2. group Id
        OG001
        value
        8
      units
      Participants
    title
    Day 5
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1622
        value
        0.3055
      2. group Id
        OG001
        spread
        0.1425
        value
        0.3105
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 5
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.1225
        value
        0.2776
      2. group Id
        OG001
        spread
        0.1596
        value
        0.2726
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        11
      units
      Participants
    title
    Week 10
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      11
    units
    Participants
description
The fractional volume of extravascular extracellular space (Ve) was used to evaluate clinical outcomes. The average for the distribution across the whole region of interest (ROI) was calculated as a summary measure for each data set.
dispersion Type
Standard Deviation
groups
  1. description
    Stratum A participants had primary tumors potentially resectable by aggressive surgery, such as limb-salvage surgery or amputation, and no evidence of metastasis.
    id
    OG000
    title
    A: Localized Resectable Disease
  2. description
    Stratum C participants had metastatic tumors.
    id
    OG001
    title
    C: Metastatic Tumors
param Type
MEAN
population Description
The number analyzed at each time point differed due to missing observations at some of the time points
reporting Status
POSTED
time Frame
Baseline through Week 10
title
Mean Ve
type
SECONDARY
unit Of Measure
(unitless)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice