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NCT00545792 · OUTCOME

Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy

Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers · Source last updated 2017-03-15

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
1-year

What was measured

Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.

Analysis population: 20 patients received and completed treatment.

Groups in this outcome

Avastin

Avastin and daily radiation Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.

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

Analysis denominator · Participants

GroupSource count
Avastin20

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Avastin16Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    estimate Comment
    The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.
    group Description
    Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Single point estiamte of 1-yr PFS
    param Value
    0.8
Complete source fields
analyses
  1. ci Lower Limit
    0.56
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.94
    estimate Comment
    The reported 1-year PFS rate 80% (Exact 95% CI: 56% - 94%) was the proportion of the patients remained progression free after 12 months.
    group Description
    Single-arm feasibility study; Kaplan Meier analysis was applied to estimate one-year PFS distribution as well as to calculate proportion of patients remain progression free by month 12.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Single point estiamte of 1-yr PFS
    param Value
    0.8
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Progression free survival was calculated from the date of diagnosis to the date of disease progression as detected by clinical examination or imaging.
groups
  1. description
    Avastin and daily radiation Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses.
    id
    OG000
    title
    Avastin
param Type
NUMBER
population Description
20 patients received and completed treatment.
reporting Status
POSTED
time Frame
1-year
title
Single Point Estimate of 1-year Progression-free Survival of Patients Treated With Concurrent Avastin and Daily Pelvic Radiation With no Other Concurrent Chemotherapy
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice