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NCT02516241 · OUTCOME

Alive at 24 Months (OS24), PD-L1-High Analysis Set

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).

What was measured

Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.

Analysis population: The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control

Groups in this outcome

Combination Therapy

MEDI4736 (Durvalumab) + Tremelimumab

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
Combination Therapy205
Monotherapy209
Standard of Care207

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Combination Therapy43.7Not reported36.850.3Not reported
Monotherapy36.0Not reported29.542.6Not reported
Standard of Care29.3Not reported23.135.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.8
        upper Limit
        50.3
        value
        43.7
      2. group Id
        OG001
        lower Limit
        29.5
        upper Limit
        42.6
        value
        36.0
      3. group Id
        OG002
        lower Limit
        23.1
        upper Limit
        35.7
        value
        29.3
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      209
    3. group Id
      OG002
      value
      207
    units
    Participants
description
Alive at 24 months (OS24) is defined as the Kaplan-Meier estimate of OS at 24 months.
dispersion Type
95% Confidence Interval
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    OG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    OG001
    title
    Monotherapy
  3. description
    Standard of Care Chemotherapy Treatment
    id
    OG002
    title
    Standard of Care
param Type
NUMBER
population Description
The PD-L1-High analysis set will include the subset of patients in the FAS whose PD-L1 status is PD-L1-High as defined by an Immunohistochemistry (IHC) assay developed by Ventana as: ≥25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR ≥25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control
reporting Status
POSTED
time Frame
From randomization date until death due to any cause, assessed up to 24 months or the data cut-off date (27JAN2020).
title
Alive at 24 Months (OS24), PD-L1-High Analysis Set
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice