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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

Histologic Grade 1

Not reported

Histologic Grade 2

Not reported

Histologic Grade 3

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
Histologic Grade 160
Histologic Grade 279
Histologic Grade 3355

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Histologic Grade 10.00Not reported0.00NADispersion can't be estimated because no participants with histological grade 1 had a distant metastasis.
Histologic Grade 25.06Not reported0.239.90Not reported
Histologic Grade 323.38Not reported18.9827.78Not 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 histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    p Value
    0.0228
    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 histologic (POG) grade after accounting for the effects of disease extent (non-metastatic; metastatic), site of the primary tumor (body wall; extremity; head/neck; visceral), tumor size (\<=5cm; \>5cm), tumor depth (deep; superficial), tumor invasiveness (invasive; non-invasive), and extent of resection of the primary tumor (less than total resection; margin -; margin +) .
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    p Value
    0.0228
    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. comment
        Dispersion can't be estimated because no participants with histological grade 1 had a distant metastasis.
        group Id
        OG000
        lower Limit
        0.00
        upper Limit
        NA
        value
        0.00
      2. group Id
        OG001
        lower Limit
        0.23
        upper Limit
        9.90
        value
        5.06
      3. group Id
        OG002
        lower Limit
        18.98
        upper Limit
        27.78
        value
        23.38
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      79
    3. group Id
      OG002
      value
      355
    units
    Participants
description
Percent of patients who had distant metastasis.
dispersion Type
95% Confidence Interval
groups
  1. id
    OG000
    title
    Histologic Grade 1
  2. id
    OG001
    title
    Histologic Grade 2
  3. id
    OG002
    title
    Histologic Grade 3
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

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

Preserved source evidence · Not medical advice