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NCT00102804 · OUTCOME

Overall Survival (OS) Time

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC) · Source last updated 2014-12-29

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
Randomization to date of death from any cause (up to 41 months)

What was measured

OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.

Analysis population: Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.

Groups in this outcome

Pemetrexed and BSC

Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

Placebo and BSC

Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.

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

Analysis denominator · Participants

GroupSource count
Pemetrexed and BSC441
Placebo and BSC222

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed and BSC13.37Not reported11.9315.87Not reported
Placebo and BSC10.58Not reported8.7412.02Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.93
        upper Limit
        15.87
        value
        13.37
      2. group Id
        OG001
        lower Limit
        8.74
        upper Limit
        12.02
        value
        10.58
denoms
  1. counts
    1. group Id
      OG000
      value
      441
    2. group Id
      OG001
      value
      222
    units
    Participants
description
OS time was the elapsed time from the date of randomization to the date of death from any cause. OS was censored at the last date of contact for participants who were not known to have died as of the data-inclusion cut-off date for analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pemetrexed: 500 mg/m\^2, IV administration, q 21 days, until disease progression. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    OG000
    title
    Pemetrexed and BSC
  2. description
    Placebo: IV administration, q 21 days. BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician.
    id
    OG001
    title
    Placebo and BSC
param Type
MEDIAN
population Description
Participants who signed the ICF and completed the randomized process are reported according to the treatment arm to which they were randomized. Participants censored: N = 138, 48 participants in the pemetrexed and placebo treatment arms, respectively.
reporting Status
POSTED
time Frame
Randomization to date of death from any cause (up to 41 months)
title
Overall Survival (OS) Time
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice