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NCT01642004 · OUTCOME

Overall Survival (OS) Rate in All Randomized Participants - Extended Collection

Study of BMS-936558 (Nivolumab) Compared to Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-small Cell Lung Cancer (NSCLC) (CheckMate 017) · Source last updated 2022-12-28

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

Measure
NUMBER
Unit
Percent probability of OS
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization up to the specified timepoints, up to 84 months

What was measured

The overall survival rate is the probability that a participant will be alive at the specified timepoints following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.

Analysis population: All randomized participants

Groups in this outcome

Nivolumab

Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.

Docetaxel

Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.

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

Analysis denominator · Participants

GroupSource count
Nivolumab135
Docetaxel137

Reported measurements

6 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab63.7Not reported55.071.2Not reported
Docetaxel50.4Not reported41.758.4Not reported
12 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab42.2Not reported33.850.4Not reported
Docetaxel24.1Not reported17.331.5Not reported
18 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab28.1Not reported20.835.9Not reported
Docetaxel12.4Not reported7.618.5Not reported
24 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab23.0Not reported16.330.3Not reported
Docetaxel8.0Not reported4.313.3Not reported
36 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab15.6Not reported10.022.2Not reported
Docetaxel5.8Not reported2.710.6Not reported
48 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab13.1Not reported8.119.5Not reported
Docetaxel4.4Not reported1.88.8Not reported
60 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab12.3Not reported7.418.5Not reported
Docetaxel3.6Not reported1.47.8Not reported
72 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab11.4Not reported6.717.5Not reported
Docetaxel2.7Not reported0.86.7Not reported
84 months
Values in Percent probability of OS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab9.6Not reported5.315.5Not reported
Docetaxel0.0Not reportedNANALower and upper limit not calculated due to insufficient number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.0
        upper Limit
        71.2
        value
        63.7
      2. group Id
        OG001
        lower Limit
        41.7
        upper Limit
        58.4
        value
        50.4
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.8
        upper Limit
        50.4
        value
        42.2
      2. group Id
        OG001
        lower Limit
        17.3
        upper Limit
        31.5
        value
        24.1
    title
    12 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.8
        upper Limit
        35.9
        value
        28.1
      2. group Id
        OG001
        lower Limit
        7.6
        upper Limit
        18.5
        value
        12.4
    title
    18 months
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.3
        upper Limit
        30.3
        value
        23.0
      2. group Id
        OG001
        lower Limit
        4.3
        upper Limit
        13.3
        value
        8.0
    title
    24 months
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.0
        upper Limit
        22.2
        value
        15.6
      2. group Id
        OG001
        lower Limit
        2.7
        upper Limit
        10.6
        value
        5.8
    title
    36 months
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.1
        upper Limit
        19.5
        value
        13.1
      2. group Id
        OG001
        lower Limit
        1.8
        upper Limit
        8.8
        value
        4.4
    title
    48 months
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.4
        upper Limit
        18.5
        value
        12.3
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        7.8
        value
        3.6
    title
    60 months
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.7
        upper Limit
        17.5
        value
        11.4
      2. group Id
        OG001
        lower Limit
        0.8
        upper Limit
        6.7
        value
        2.7
    title
    72 months
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        15.5
        value
        9.6
      2. comment
        Lower and upper limit not calculated due to insufficient number of events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0.0
    title
    84 months
denoms
  1. counts
    1. group Id
      OG000
      value
      135
    2. group Id
      OG001
      value
      137
    units
    Participants
description
The overall survival rate is the probability that a participant will be alive at the specified timepoints following randomization. Overall survival was defined as the time between the date of randomization and the date of death as a result of any cause. Survival rates were determined via Kaplan-Meier estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends. Eligible patients may receive nivolumab at 480mg every 4 weeks until documented disease progression, discontinuation, withdrawal of consent or the study ends.
    id
    OG000
    title
    Nivolumab
  2. description
    Docetaxel 75mg/m\^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or study ends.
    id
    OG001
    title
    Docetaxel
param Type
NUMBER
population Description
All randomized participants
reporting Status
POSTED
time Frame
From the date of randomization up to the specified timepoints, up to 84 months
title
Overall Survival (OS) Rate in All Randomized Participants - Extended Collection
type
POST_HOC
unit Of Measure
Percent probability of OS

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Preserved source evidence · Not medical advice