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NCT02516241 · OUTCOME

Duration of Response (DoR), Full 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
MEDIAN
Unit
Months
Interval / dispersion
Inter-Quartile Range
Time frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).

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

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 Therapy342
Monotherapy346
Standard of Care344

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Combination Therapy11.1Not reported4.3NAupper limit is not reached
Monotherapy9.3Not reported5.4NAupper limit is not reached
Standard of Care5.7Not reported3.79.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        upper limit is not reached
        group Id
        OG000
        lower Limit
        4.3
        upper Limit
        NA
        value
        11.1
      2. comment
        upper limit is not reached
        group Id
        OG001
        lower Limit
        5.4
        upper Limit
        NA
        value
        9.3
      3. group Id
        OG002
        lower Limit
        3.7
        upper Limit
        9.3
        value
        5.7
denoms
  1. counts
    1. group Id
      OG000
      value
      342
    2. group Id
      OG001
      value
      346
    3. group Id
      OG002
      value
      344
    units
    Participants
description
Duration of response (DoR) (per RECIST 1.1 as assessed by investigator) was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression (i.e. date of PFS event or censoring - date of first response + 1).
dispersion Type
Inter-Quartile Range
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
MEDIAN
population Description
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
reporting Status
POSTED
time Frame
Tumour scans performed at baseline then every 8 weeks since randomization until confirmed disease progression. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
Duration of Response (DoR), Full Analysis Set
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice