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NCT00085202 · OUTCOME

Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.

Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor · Source last updated 2024-02-08

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

Measure
NUMBER
Unit
probability of PFS at 2 years
Interval / dispersion
95% Confidence Interval
Time frame
2 years after tumor cell analysis in 122 participants

What was measured

122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.

Analysis population: Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.

Groups in this outcome

ERBB2 Positive & Average Risk

54 participants who were ERBB2 positive and in the average risk group.

ERBB2 Positive & High Risk

23 participants who were ERBB2 positive and in the high risk group

ERBB2 Negative & Average Risk

31 participants who were ERBB2 negative and in the average risk group

ERBB2 Negative & High Risk

14 participants who were ERBB2 negative and in the high risk group

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

Analysis denominator · Participants

GroupSource count
ERBB2 Positive & Average Risk54
ERBB2 Positive & High Risk23
ERBB2 Negative & Average Risk31
ERBB2 Negative & High Risk14

Reported measurements

Source class 1
Values in probability of PFS at 2 years · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ERBB2 Positive & Average Risk83.3Not reported73.593.1Not reported
ERBB2 Positive & High Risk69.6Not reported50.888.4Not reported
ERBB2 Negative & Average Risk93.5Not reported85.1100Not reported
ERBB2 Negative & High Risk71.4Not reported48.993.9Not reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0206
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    3. OG002
    4. OG003
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0206
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.5
        upper Limit
        93.1
        value
        83.3
      2. group Id
        OG001
        lower Limit
        50.8
        upper Limit
        88.4
        value
        69.6
      3. group Id
        OG002
        lower Limit
        85.1
        upper Limit
        100
        value
        93.5
      4. group Id
        OG003
        lower Limit
        48.9
        upper Limit
        93.9
        value
        71.4
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    2. group Id
      OG001
      value
      23
    3. group Id
      OG002
      value
      31
    4. group Id
      OG003
      value
      14
    units
    Participants
description
122 participants with a diagnosis of medulloblastoma were grouped by ERBB2 positive/negative assessment and risk group into 4 groups. Progression-free survival was calculated from the date of diagnosis to the date of disease progression/relapse, the date of death, or the date of last contact. The log-rank test was used to compare the PFS distributions of ERBB2 groups.
dispersion Type
95% Confidence Interval
groups
  1. description
    54 participants who were ERBB2 positive and in the average risk group.
    id
    OG000
    title
    ERBB2 Positive & Average Risk
  2. description
    23 participants who were ERBB2 positive and in the high risk group
    id
    OG001
    title
    ERBB2 Positive & High Risk
  3. description
    31 participants who were ERBB2 negative and in the average risk group
    id
    OG002
    title
    ERBB2 Negative & Average Risk
  4. description
    14 participants who were ERBB2 negative and in the high risk group
    id
    OG003
    title
    ERBB2 Negative & High Risk
param Type
NUMBER
population Description
Analysis was completed for the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of PNET, PNET variants, or ATRT were not included in this analysis.
reporting Status
POSTED
time Frame
2 years after tumor cell analysis in 122 participants
title
Progression-Free Survival (PFS) Compared Between ERBB2 Assessment and Risk Group.
type
PRIMARY
unit Of Measure
probability of PFS at 2 years

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

Preserved source evidence · Not medical advice