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NCT00346164 · OUTCOME

Incidence of Distant Metastasis

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma · Source last updated 2022-04-28

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 10 years

What was measured

Percent of patients who had distant metastasis.

Analysis population: 94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.

Groups in this outcome

Non-metastatic

Not reported

Metastatic

Not reported

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

Analysis denominator · Participants

GroupSource count
Non-metastatic425
Metastatic69

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Non-metastatic10.59Not reported7.6613.51Not reported
Metastatic60.87Not reported49.3572.39Not reported

Source statistical analyses

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

  1. group Description
    The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Comment
    Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. group Description
    The logistic regression model was used to evaluate prognostic impact of disease extent (non-metastatic; metastatic) after accounting for the effects of site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), extent of resection of the primary tumor (less than total resection; margin -; margin +), and histologic (POG) grade.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    <0.0001
    statistical Comment
    Firth logistic regression is used to overcome the issue of quasi-complete separation of data points.
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.66
        upper Limit
        13.51
        value
        10.59
      2. group Id
        OG001
        lower Limit
        49.35
        upper Limit
        72.39
        value
        60.87
denoms
  1. counts
    1. group Id
      OG000
      value
      425
    2. group Id
      OG001
      value
      69
    units
    Participants
description
Percent of patients who had distant metastasis.
dispersion Type
95% Confidence Interval
groups
  1. id
    OG000
    title
    Non-metastatic
  2. id
    OG001
    title
    Metastatic
param Type
NUMBER
population Description
94 participants were excluded because of ineligibility, incorrect treatment, or absence of evaluation for tumor invasiveness and histologic grade.
reporting Status
POSTED
time Frame
Up to 10 years
title
Incidence of Distant Metastasis
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice