NCT02516241 · OUTCOME

Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, 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: MEAN
Unit: Scores on a scale
Interval / dispersion: Standard Error
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

the change from baseline in the following total/index scores will be evaluated as secondary endpoints: FACT-BL TOI (refer to as TOI), FACT-BL Total score, and NFBlSI-18 score. All the 5 subscales (PWB (0-28), FWB (0-28), EWB (0-24), SWB (0-28), and BlCS(0-48)) are summed as the FACT-BL total score (range 0-156), while the sum of PWB, FWB and BICS constitutes the FACT-BL TOI (range 0-104). NFBlSI-18 (range 0-72) is based on the scores of 16 items (GP4, C2, BL1, GP3, GE6, GE1, C6, BL5, GF5, GP2, GP1, GP6, C3, GP5, GF3, GF7) and 2 extra items "I feel weak all overall" and "I feel light-headed (dizzy)". The range of each item is 0-4. Higher score represent worse outcome.

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

Group	Source count
Combination Therapy	342
Monotherapy	346
Standard of Care	344

Reported measurements

NFBLSI - 18 Score (Average overall visits)

Analysis denominator · Participants

Group	Source count
Combination Therapy	220
Monotherapy	204
Standard of Care	189

Values in Scores on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	-3.7	0.70	Not reported	Not reported	Not reported
Monotherapy	-3.1	0.76	Not reported	Not reported	Not reported
Standard of Care	-5.2	0.82	Not reported	Not reported	Not reported

FACT-BL TOI (Average overall visits)

Analysis denominator · Participants

Group	Source count
Combination Therapy	220
Monotherapy	204
Standard of Care	189

Values in Scores on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	-5.5	0.87	Not reported	Not reported	Not reported
Monotherapy	-3.9	0.95	Not reported	Not reported	Not reported
Standard of Care	-7.2	1.02	Not reported	Not reported	Not reported

FACT-BL Total score (Average overall visits)

Analysis denominator · Participants

Group	Source count
Combination Therapy	220
Monotherapy	204
Standard of Care	189

Values in Scores on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Combination Therapy	-7.2	1.19	Not reported	Not reported	Not reported
Monotherapy	-4.7	1.30	Not reported	Not reported	Not reported
Standard of Care	-8.8	1.39	Not reported	Not reported	Not reported

Source statistical analyses

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

ci Lower Limit
-0.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.59
group Description
NFBLSI- 18 score (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1617
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.5
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.29
group Description
NFBLSI- 18 score (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0578
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
2.1
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.91
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.32
group Description
FACT-BL TOI (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2003
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.7
statistical Method
Mixed Models Analysis
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.00
group Description
FACT-BL TOI (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0178
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
3.3
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.96
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.17
group Description
FACT-BL Total score (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.3765
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.6
statistical Method
Mixed Models Analysis
ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.81
group Description
FACT-BL Total score (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0300
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
4.1
statistical Method
Mixed Models Analysis

Complete source fields

analyses

ci Lower Limit
-0.6
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
3.59
group Description
NFBLSI- 18 score (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.1617
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.5
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.07
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.29
group Description
NFBLSI- 18 score (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0578
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
2.1
statistical Method
Mixed Models Analysis
ci Lower Limit
-0.91
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
4.32
group Description
FACT-BL TOI (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.2003
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.7
statistical Method
Mixed Models Analysis
ci Lower Limit
0.57
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
6.00
group Description
FACT-BL TOI (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0178
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
3.3
statistical Method
Mixed Models Analysis
ci Lower Limit
-1.96
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
5.17
group Description
FACT-BL Total score (Average overall visits)
group Ids
OG000
OG002
non Inferiority Type
SUPERIORITY
p Value
0.3765
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
1.6
statistical Method
Mixed Models Analysis
ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
7.81
group Description
FACT-BL Total score (Average overall visits)
group Ids
OG001
OG002
non Inferiority Type
SUPERIORITY
p Value
0.0300
p Value Comment
MMRM model included patient, treatment, cisplatin eligibility, PD-L1 status and visceral metastasis, visit and treatment by visit interaction as explanatory variables, and the appropriate baseline FACT-BL value as a covariate.
param Type
Mean Difference (Final Values)
param Value
4.1
statistical Method
Mixed Models Analysis

classes

categories
measurements
group Id
OG000
spread
0.70
value
-3.7
group Id
OG001
spread
0.76
value
-3.1
group Id
OG002
spread
0.82
value
-5.2
denoms
counts
group Id
OG000
value
220
group Id
OG001
value
204
group Id
OG002
value
189
units
Participants
title
NFBLSI - 18 Score (Average overall visits)
categories
measurements
group Id
OG000
spread
0.87
value
-5.5
group Id
OG001
spread
0.95
value
-3.9
group Id
OG002
spread
1.02
value
-7.2
denoms
counts
group Id
OG000
value
220
group Id
OG001
value
204
group Id
OG002
value
189
units
Participants
title
FACT-BL TOI (Average overall visits)
categories
measurements
group Id
OG000
spread
1.19
value
-7.2
group Id
OG001
spread
1.30
value
-4.7
group Id
OG002
spread
1.39
value
-8.8
denoms
counts
group Id
OG000
value
220
group Id
OG001
value
204
group Id
OG002
value
189
units
Participants
title
FACT-BL Total score (Average overall visits)

denoms

counts
group Id
OG000
value
342
group Id
OG001
value
346
group Id
OG002
value
344
units
Participants

description

dispersion Type

Standard Error

groups

description
MEDI4736 (Durvalumab) + Tremelimumab
id
OG000
title
Combination Therapy
description
MEDI4736 (Durvalumab)
id
OG001
title
Monotherapy
description
Standard of Care Chemotherapy Treatment
id
OG002
title
Standard of Care

param Type

MEAN

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

Change From Baseline in FACT-BL (Derived NFBlSI-18 Score, FACT-BL TOI, and FACT-BL Total Score) by MMRM Analysis, Full Analysis Set -Durvalumab + Tremelimumab Combination Therapy vs SoC and Durvalumab Mono Therapy vs SoC

type

SECONDARY

unit Of Measure

Scores on a scale

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Preserved source evidence · Not medical advice