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NCT00789373 · OUTCOME

Overall Survival (OS)

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer · Source last updated 2018-12-14

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
Date of randomization to the date of death from any cause up to 39.5 months

What was measured

OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.

Analysis population: All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.

Groups in this outcome

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed

pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care

Pemetrexed + Cisplatin Followed by Placebo

pemetrexed and cisplatin followed by placebo plus best supportive care

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 + Cisplatin Followed by Maintenance Pemetrexed359
Pemetrexed + Cisplatin Followed by Placebo180

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed13.86Not reported12.7516.03Not reported
Pemetrexed + Cisplatin Followed by Placebo11.01Not reported9.9512.52Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    estimate Comment
    Unadjusted HR from Cox model with treatment as the only cofactor.
    group Description
    Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0195
    p Value Comment
    The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.64
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.96
    estimate Comment
    Unadjusted HR from Cox model with treatment as the only cofactor.
    group Description
    Type 1 (alpha) error was controlled for the analyses of both PFS and OS in order to maintain an overall two-sided alpha level of 0.05 using a statistical gatekeeping and alpha spending scheme. The unconditional statistical power of the final OS analysis was 93%.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0195
    p Value Comment
    The predefined alpha for the final analysis of OS is 0.0498 for the unadjusted log-rank test.
    param Type
    Hazard Ratio (HR)
    param Value
    0.78
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.75
        upper Limit
        16.03
        value
        13.86
      2. group Id
        OG001
        lower Limit
        9.95
        upper Limit
        12.52
        value
        11.01
denoms
  1. counts
    1. group Id
      OG000
      value
      359
    2. group Id
      OG001
      value
      180
    units
    Participants
description
OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    pemetrexed and cisplatin followed by maintenance pemetrexed plus best supportive care
    id
    OG000
    title
    Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed
  2. description
    pemetrexed and cisplatin followed by placebo plus best supportive care
    id
    OG001
    title
    Pemetrexed + Cisplatin Followed by Placebo
param Type
MEDIAN
population Description
All randomized participants. In the Pemetrexed maintenance arm 103 (28.7%) participants were censored and in the Placebo maintenance arm 39 (21.7%) participants were censored.
reporting Status
POSTED
time Frame
Date of randomization to the date of death from any cause up to 39.5 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice