Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02516241 · OUTCOME

Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).

What was measured

Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.

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

Patients with improvement in fatigue

Analysis denominator · Participants

GroupSource count
Combination Therapy141
Monotherapy129
Standard of Care115
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy38Not reportedNot reportedNot reportedNot reported
Monotherapy37Not reportedNot reportedNot reportedNot reported
Standard of Care24Not reportedNot reportedNot reportedNot reported
Patient with deterioration in pain

Analysis denominator · Participants

GroupSource count
Combination Therapy265
Monotherapy270
Standard of Care226
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination Therapy142Not reportedNot reportedNot reportedNot reported
Monotherapy130Not reportedNot reportedNot reportedNot reported
Standard of Care83Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.6
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood
    group Description
    Patients with improvement in fatigue
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2419
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.4
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patients with improvement in fatigue
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1553
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.5
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patient with deterioration in pain
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    2
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.3
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patient with deterioration in pain
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0148
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.6
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.6
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood
    group Description
    Patients with improvement in fatigue
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.2419
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.4
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patients with improvement in fatigue
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.1553
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.5
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    1.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patient with deterioration in pain
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0003
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    2
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    1.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.3
    estimate Comment
    The OR and confidence interval (CI) were calculated using logistic regression, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status, with 95% CI calculated by profile likelihood.
    group Description
    Patient with deterioration in pain
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0148
    p Value Comment
    P-value was based on twice the change in log-likelihood resulting from logistic regression model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.
    param Type
    Odds Ratio (OR)
    param Value
    1.6
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        37
      3. group Id
        OG002
        value
        24
    denoms
    1. counts
      1. group Id
        OG000
        value
        141
      2. group Id
        OG001
        value
        129
      3. group Id
        OG002
        value
        115
      units
      Participants
    title
    Patients with improvement in fatigue
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        142
      2. group Id
        OG001
        value
        130
      3. group Id
        OG002
        value
        83
    denoms
    1. counts
      1. group Id
        OG000
        value
        265
      2. group Id
        OG001
        value
        270
      3. group Id
        OG002
        value
        226
      units
      Participants
    title
    Patient with deterioration in pain
denoms
  1. counts
    1. group Id
      OG000
      value
      342
    2. group Id
      OG001
      value
      346
    3. group Id
      OG002
      value
      344
    units
    Participants
description
Fatigue will be based on the question of "I have a lack of energy" and pain will be based on the question of "I have pain", according to GP1 and GP4 in PWB, respectively. Improvement in fatigue is defined at least 1 point improvement from baseline using GP1 of FACT-BL. Deterioration in pain is defined as at least 1 point deterioration from baseline using GP4 of FACT-BL.
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
COUNT_OF_PARTICIPANTS
population Description
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
reporting Status
POSTED
time Frame
At baseline then every 8 weeks until second progression/death, whichever comes first. Assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).
title
Improvement in Fatigue and Deterioration in Pain Per FACT-BL, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice