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NCT02516241 · OUTCOME

OS, Full Analysis Set - Durvalumab Monotherapy vs SoC

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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 randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Analysis population: Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

Groups in this outcome

Monotherapy

MEDI4736 (Durvalumab)

Standard of Care

Standard of Care Chemotherapy Treatment

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

Analysis denominator · Participants

GroupSource count
Monotherapy346
Standard of Care344

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Monotherapy13.2Not reported10.315Not reported
Standard of Care12.1Not reported10.914Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.830
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.169
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8637
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.830
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.169
    estimate Comment
    The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.8637
    p Value Comment
    The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Hazard Ratio (HR)
    param Value
    0.99
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.3
        upper Limit
        15
        value
        13.2
      2. group Id
        OG001
        lower Limit
        10.9
        upper Limit
        14
        value
        12.1
denoms
  1. counts
    1. group Id
      OG000
      value
      346
    2. group Id
      OG001
      value
      344
    units
    Participants
description
The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
dispersion Type
95% Confidence Interval
groups
  1. description
    MEDI4736 (Durvalumab)
    id
    OG000
    title
    Monotherapy
  2. description
    Standard of Care Chemotherapy Treatment
    id
    OG001
    title
    Standard of Care
param Type
MEDIAN
population Description
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
reporting Status
POSTED
time Frame
From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
OS, Full Analysis Set - Durvalumab Monotherapy vs SoC
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice