Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
A Study Of Avelumab In Patients With Locally Advanced Or Metastatic Urothelial Cancer (JAVELIN Bladder 100) · Source last updated 2024-03-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
MEAN
Unit
millimeters of mercury
Interval / dispersion
Standard Deviation
Time frame
Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
What was measured
Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).
Analysis population: Safety set analyzed. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
Groups in this outcome
Avelumab + Best Supportive Care (BSC)
Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
Best Supportive Care
As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
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
Avelumab + Best Supportive Care (BSC)
344
Best Supportive Care
345
Reported measurements
Baseline (C1D1): Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
324
Best Supportive Care
329
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
75.7
10.81
Not reported
Not reported
Not reported
Best Supportive Care
77.0
10.48
Not reported
Not reported
Not reported
Change at Cycle 2, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
295
Best Supportive Care
287
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-0.9
9.37
Not reported
Not reported
Not reported
Best Supportive Care
-0.0
9.06
Not reported
Not reported
Not reported
Change at Cycle 3, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
268
Best Supportive Care
228
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.7
10.36
Not reported
Not reported
Not reported
Best Supportive Care
-1.6
9.38
Not reported
Not reported
Not reported
Change at Cycle 4, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
230
Best Supportive Care
153
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.7
9.97
Not reported
Not reported
Not reported
Best Supportive Care
-1.0
9.90
Not reported
Not reported
Not reported
Change at Cycle 5, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
201
Best Supportive Care
119
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.1
10.60
Not reported
Not reported
Not reported
Best Supportive Care
-1.0
10.22
Not reported
Not reported
Not reported
Change at Cycle 6, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
181
Best Supportive Care
107
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.2
10.89
Not reported
Not reported
Not reported
Best Supportive Care
-1.1
10.89
Not reported
Not reported
Not reported
Change at Cycle 7, Day 1: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
158
Best Supportive Care
81
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-0.7
10.90
Not reported
Not reported
Not reported
Best Supportive Care
0.2
9.95
Not reported
Not reported
Not reported
Change at End of Treatment: Sitting DBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
190
Best Supportive Care
237
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-0.1
12.09
Not reported
Not reported
Not reported
Best Supportive Care
-1.7
10.23
Not reported
Not reported
Not reported
Baseline (C1D1): Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
324
Best Supportive Care
329
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
131.3
17.34
Not reported
Not reported
Not reported
Best Supportive Care
130.6
16.32
Not reported
Not reported
Not reported
Change at Cycle 2, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
295
Best Supportive Care
287
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-2.2
14.85
Not reported
Not reported
Not reported
Best Supportive Care
-0.3
13.79
Not reported
Not reported
Not reported
Change at Cycle 3, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
268
Best Supportive Care
228
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.9
16.10
Not reported
Not reported
Not reported
Best Supportive Care
1.0
14.94
Not reported
Not reported
Not reported
Change at Cycle 4, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
230
Best Supportive Care
153
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-0.6
16.54
Not reported
Not reported
Not reported
Best Supportive Care
1.3
16.54
Not reported
Not reported
Not reported
Change at Cycle 5, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
201
Best Supportive Care
119
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.9
15.49
Not reported
Not reported
Not reported
Best Supportive Care
1.9
15.85
Not reported
Not reported
Not reported
Change at Cycle 6, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
181
Best Supportive Care
107
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-2.3
15.77
Not reported
Not reported
Not reported
Best Supportive Care
3.3
16.81
Not reported
Not reported
Not reported
Change at Cycle 7, Day 1: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
158
Best Supportive Care
81
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-1.8
16.13
Not reported
Not reported
Not reported
Best Supportive Care
2.7
19.86
Not reported
Not reported
Not reported
Change at End of Treatment: Sitting SBP
Analysis denominator · Participants
Group
Source count
Avelumab + Best Supportive Care (BSC)
190
Best Supportive Care
237
Values in millimeters of mercury · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Avelumab + Best Supportive Care (BSC)
-0.9
18.99
Not reported
Not reported
Not reported
Best Supportive Care
-0.3
16.78
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
10.81
value
75.7
group Id
OG001
spread
10.48
value
77.0
denoms
counts
group Id
OG000
value
324
group Id
OG001
value
329
units
Participants
title
Baseline (C1D1): Sitting DBP
categories
measurements
group Id
OG000
spread
9.37
value
-0.9
group Id
OG001
spread
9.06
value
-0.0
denoms
counts
group Id
OG000
value
295
group Id
OG001
value
287
units
Participants
title
Change at Cycle 2, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
10.36
value
-1.7
group Id
OG001
spread
9.38
value
-1.6
denoms
counts
group Id
OG000
value
268
group Id
OG001
value
228
units
Participants
title
Change at Cycle 3, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
9.97
value
-1.7
group Id
OG001
spread
9.90
value
-1.0
denoms
counts
group Id
OG000
value
230
group Id
OG001
value
153
units
Participants
title
Change at Cycle 4, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
10.60
value
-1.1
group Id
OG001
spread
10.22
value
-1.0
denoms
counts
group Id
OG000
value
201
group Id
OG001
value
119
units
Participants
title
Change at Cycle 5, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
10.89
value
-1.2
group Id
OG001
spread
10.89
value
-1.1
denoms
counts
group Id
OG000
value
181
group Id
OG001
value
107
units
Participants
title
Change at Cycle 6, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
10.90
value
-0.7
group Id
OG001
spread
9.95
value
0.2
denoms
counts
group Id
OG000
value
158
group Id
OG001
value
81
units
Participants
title
Change at Cycle 7, Day 1: Sitting DBP
categories
measurements
group Id
OG000
spread
12.09
value
-0.1
group Id
OG001
spread
10.23
value
-1.7
denoms
counts
group Id
OG000
value
190
group Id
OG001
value
237
units
Participants
title
Change at End of Treatment: Sitting DBP
categories
measurements
group Id
OG000
spread
17.34
value
131.3
group Id
OG001
spread
16.32
value
130.6
denoms
counts
group Id
OG000
value
324
group Id
OG001
value
329
units
Participants
title
Baseline (C1D1): Sitting SBP
categories
measurements
group Id
OG000
spread
14.85
value
-2.2
group Id
OG001
spread
13.79
value
-0.3
denoms
counts
group Id
OG000
value
295
group Id
OG001
value
287
units
Participants
title
Change at Cycle 2, Day 1: Sitting SBP
categories
measurements
group Id
OG000
spread
16.10
value
-1.9
group Id
OG001
spread
14.94
value
1.0
denoms
counts
group Id
OG000
value
268
group Id
OG001
value
228
units
Participants
title
Change at Cycle 3, Day 1: Sitting SBP
categories
measurements
group Id
OG000
spread
16.54
value
-0.6
group Id
OG001
spread
16.54
value
1.3
denoms
counts
group Id
OG000
value
230
group Id
OG001
value
153
units
Participants
title
Change at Cycle 4, Day 1: Sitting SBP
denoms
counts
group Id
OG000
value
344
group Id
OG001
value
345
units
Participants
description
Vital signs included blood pressure and pulse rate. Blood pressure included sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP).
dispersion Type
Standard Deviation
groups
description
Participants received an intravenous (IV) infusion of 10 milligrams per kilograms (mg/kg) of Avelumab along with BSC, on Day 1 and 15 of each 28 days treatment cycle, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. BSC was administered as per the treating physician. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
id
OG000
title
Avelumab + Best Supportive Care (BSC)
description
As prescribed by the treating physician, participants received BSC which included treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management, until confirmed disease progression, participant refusal, lost to follow up, unacceptable toxicity, or study termination by the sponsor, whichever occurred first. Participants were followed up until death, end of the study or withdrawal of consent, whichever comes first, regardless of initiation of new anti-cancer therapy.
id
OG001
title
Best Supportive Care
param Type
MEAN
population Description
Safety set analyzed. All participants reported under 'Overall Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. Here, 'Number analyzed' = participants evaluable for this outcome measure at specified time points.
reporting Status
POSTED
time Frame
Baseline (Day [D] 1 of Cycle [C] 1), Day 1 of Cycle 2, 3, 4, 5, 6, 7 , EOT visit (for a maximum duration of 41 months) (each cycle=28 days)
title
Change From Baseline in Vital Signs - Blood Pressure at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
Triangle