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NCT03036098 · OUTCOME

Overall Survival (OS) in All Randomized Participants for Primary Study

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)

What was measured

This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.

Analysis population: All Randomized Participants - Primary Study

Groups in this outcome

Treatment 1

Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study

Treatment 2

Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study

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

Analysis denominator · Participants

GroupSource count
Treatment 1349
Treatment 2357

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment 118.76Not reported15.0521.82Not reported
Treatment 214.32Not reported12.2215.87Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15.05
        upper Limit
        21.82
        value
        18.76
      2. group Id
        OG001
        lower Limit
        12.22
        upper Limit
        15.87
        value
        14.32
denoms
  1. counts
    1. group Id
      OG000
      value
      349
    2. group Id
      OG001
      value
      357
    units
    Participants
description
This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    OG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    OG001
    title
    Treatment 2
param Type
MEDIAN
population Description
All Randomized Participants - Primary Study
reporting Status
POSTED
time Frame
From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
title
Overall Survival (OS) in All Randomized Participants for Primary Study
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice