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NCT02632409 · OUTCOME

Disease Free Survival (DFS)

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer · Source last updated 2026-07-30

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
approximately up to 48 months

What was measured

The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

Analysis population: All Randomized Participants

Groups in this outcome

Placebo

Placebo

Nivolumab

Nivolumab 240mg IV Q2W

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

Analysis denominator · Participants

GroupSource count
Placebo356
Nivolumab353

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo10.84Not reported8.2513.86Not reported
Nivolumab20.76Not reported16.4927.63Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.22
    ci Upper Limit
    0.90
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0008
    param Type
    Hazard Ratio (HR)
    param Value
    0.70
    statistical Method
    Stratified Cox Proportional hazard model
Complete source fields
analyses
  1. ci Lower Limit
    0.55
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.22
    ci Upper Limit
    0.90
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0008
    param Type
    Hazard Ratio (HR)
    param Value
    0.70
    statistical Method
    Stratified Cox Proportional hazard model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.25
        upper Limit
        13.86
        value
        10.84
      2. group Id
        OG001
        lower Limit
        16.49
        upper Limit
        27.63
        value
        20.76
denoms
  1. counts
    1. group Id
      OG000
      value
      356
    2. group Id
      OG001
      value
      353
    units
    Participants
description
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Placebo
    id
    OG000
    title
    Placebo
  2. description
    Nivolumab 240mg IV Q2W
    id
    OG001
    title
    Nivolumab
param Type
MEDIAN
population Description
All Randomized Participants
reporting Status
POSTED
time Frame
approximately up to 48 months
title
Disease Free Survival (DFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice