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NCT02743494 · OUTCOME

Overall Survival (OS)

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer · Source last updated 2025-11-18

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

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
From randomization to the date of death (up to approximately 60 months)

What was measured

Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.

Analysis population: All randomized participants.

Groups in this outcome

Nivolumab

Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.

Placebo

Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles

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

Analysis denominator · Participants

GroupSource count
Nivolumab532
Placebo262

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Nivolumab51.71Not reported41.0361.63Not reported
Placebo35.25Not reported30.7248.76Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.070
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1064
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.070
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    estimate Comment
    Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1064
    param Type
    Hazard Ratio (HR)
    param Value
    0.85
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        41.03
        upper Limit
        61.63
        value
        51.71
      2. group Id
        OG001
        lower Limit
        30.72
        upper Limit
        48.76
        value
        35.25
denoms
  1. counts
    1. group Id
      OG000
      value
      532
    2. group Id
      OG001
      value
      262
    units
    Participants
description
Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.
dispersion Type
Full Range
groups
  1. description
    Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.
    id
    OG000
    title
    Nivolumab
  2. description
    Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
All randomized participants.
reporting Status
POSTED
time Frame
From randomization to the date of death (up to approximately 60 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice