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NCT00597116 · OUTCOME

Progression-free Survival (PFS)

An Efficacy and Safety Study With Vandetanib to Treat Inoperable or Relapsed Malignant Mesothelioma · Source last updated 2016-10-10

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed from baseline to 12 months.

What was measured

Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.

Analysis population: Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.

Groups in this outcome

Vandetanib

Vandetanib 300 mg/day oral

Vinorelbine

Vinorelbine 30 mg/m2 iv, administrated weekly

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

Analysis denominator · Participants

GroupSource count
Vandetanib12
Vinorelbine10

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Vandetanib1.8Not reported1.11.8Not reported
Vinorelbine3.8Not reported2.17.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        1.8
        value
        1.8
      2. group Id
        OG001
        lower Limit
        2.1
        upper Limit
        7.3
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions.
dispersion Type
95% Confidence Interval
groups
  1. description
    Vandetanib 300 mg/day oral
    id
    OG000
    title
    Vandetanib
  2. description
    Vinorelbine 30 mg/m2 iv, administrated weekly
    id
    OG001
    title
    Vinorelbine
param Type
MEDIAN
population Description
Only patients in the evaluable for efficacy population were included. It was defined as all treated patients with no major deviations from the eligibility criteria affecting the evaluation of efficacy, who completed at least 2 cycles (unless progressive disease occurred at cycle 1) and who had at least one post-treatment tumour assessment.
reporting Status
POSTED
time Frame
Assessed from baseline to 12 months.
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice