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NCT01085630 · OUTCOME

Progression-free Survival

Pemetrexed Disodium/Observation in Treating Patients W/ Malignant Pleural Mesothelioma w/Out Progressive Disease After 1st Line Chemotherapy · Source last updated 2021-08-18

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
Baseline up to 3 years

What was measured

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.

Groups in this outcome

Arm A (Observation)

Patients undergo observation until disease progression.

Arm B (Pemetrexed)

Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm A (Observation)22
Arm B (Pemetrexed)27

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Observation)3.0Not reported2.611.9Not reported
Arm B (Pemetrexed)3.4Not reported2.89.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.6
        upper Limit
        11.9
        value
        3.0
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        9.8
        value
        3.4
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients undergo observation until disease progression.
    id
    OG000
    title
    Arm A (Observation)
  2. description
    Patients receive pemetrexed 500 mg/m2 IV over 10 minutes (or per institutional guidelines) every three weeks. Patients will continue treatment until disease progression or excess toxicity.
    id
    OG001
    title
    Arm B (Pemetrexed)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Baseline up to 3 years
title
Progression-free Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice