Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02632409 · OUTCOME

Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population

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 with PD-L1 expression ≥ 1%

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
Placebo142
Nivolumab140

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo8.41Not reported5.5921.19Not reported
NivolumabNANot reported22.01NAInsufficient number of events to calculate median value. Upper limit number not reached

Source statistical analyses

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

  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.72
    ci Upper Limit
    0.84
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0005
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Stratified Cox Proportional hazard model
Complete source fields
analyses
  1. ci Lower Limit
    0.35
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    98.72
    ci Upper Limit
    0.84
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0005
    param Type
    Hazard Ratio (HR)
    param Value
    0.54
    statistical Method
    Stratified Cox Proportional hazard model
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.59
        upper Limit
        21.19
        value
        8.41
      2. comment
        Insufficient number of events to calculate median value. Upper limit number not reached
        group Id
        OG001
        lower Limit
        22.01
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      142
    2. group Id
      OG001
      value
      140
    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 with PD-L1 expression ≥ 1%
reporting Status
POSTED
time Frame
approximately up to 48 months
title
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice