NCT02603432 · OUTCOME
Change From Baseline in Vital Signs - Pulse Rate 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
- beats per minute
- 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. Changes from baseline in sitting pulse rate were summarized.
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)
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 324 |
|---|
| Best Supportive Care | 327 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | 76.1 | 12.84 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | 77.1 | 12.95 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 2, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 295 |
|---|
| Best Supportive Care | 286 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | 0.3 | 11.81 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | 0.1 | 9.98 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 3, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 268 |
|---|
| Best Supportive Care | 226 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | -0.2 | 12.10 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | -0.4 | 10.20 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 4, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 230 |
|---|
| Best Supportive Care | 152 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | -0.5 | 12.84 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | -0.1 | 11.26 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 5, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 201 |
|---|
| Best Supportive Care | 118 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | 0.4 | 12.32 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | -1.0 | 11.45 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 6, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 181 |
|---|
| Best Supportive Care | 105 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | -0.8 | 11.54 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | -2.6 | 10.52 | Not reported | Not reported | Not reported |
|---|
Change at Cycle 7, Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 158 |
|---|
| Best Supportive Care | 80 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | -0.6 | 11.89 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | -2.6 | 11.48 | Not reported | Not reported | Not reported |
|---|
Change at End of Treatment
Analysis denominator · Participants
| Group | Source count |
|---|
| Avelumab + Best Supportive Care (BSC) | 190 |
|---|
| Best Supportive Care | 235 |
|---|
Values in beats per minute · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Avelumab + Best Supportive Care (BSC) | 2.5 | 12.25 | Not reported | Not reported | Not reported |
|---|
| Best Supportive Care | 1.4 | 12.45 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.84
- value
- 76.1
- group Id
- OG001
- spread
- 12.95
- value
- 77.1
- denoms
- counts
- group Id
- OG000
- value
- 324
- group Id
- OG001
- value
- 327
- units
- Participants
- title
- Baseline (C1D1)
- categories
- measurements
- group Id
- OG000
- spread
- 11.81
- value
- 0.3
- group Id
- OG001
- spread
- 9.98
- value
- 0.1
- denoms
- counts
- group Id
- OG000
- value
- 295
- group Id
- OG001
- value
- 286
- units
- Participants
- title
- Change at Cycle 2, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.10
- value
- -0.2
- group Id
- OG001
- spread
- 10.20
- value
- -0.4
- denoms
- counts
- group Id
- OG000
- value
- 268
- group Id
- OG001
- value
- 226
- units
- Participants
- title
- Change at Cycle 3, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.84
- value
- -0.5
- group Id
- OG001
- spread
- 11.26
- value
- -0.1
- denoms
- counts
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 152
- units
- Participants
- title
- Change at Cycle 4, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.32
- value
- 0.4
- group Id
- OG001
- spread
- 11.45
- value
- -1.0
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 118
- units
- Participants
- title
- Change at Cycle 5, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.54
- value
- -0.8
- group Id
- OG001
- spread
- 10.52
- value
- -2.6
- denoms
- counts
- group Id
- OG000
- value
- 181
- group Id
- OG001
- value
- 105
- units
- Participants
- title
- Change at Cycle 6, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 11.89
- value
- -0.6
- group Id
- OG001
- spread
- 11.48
- value
- -2.6
- denoms
- counts
- group Id
- OG000
- value
- 158
- group Id
- OG001
- value
- 80
- units
- Participants
- title
- Change at Cycle 7, Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 12.25
- value
- 2.5
- group Id
- OG001
- spread
- 12.45
- value
- 1.4
- denoms
- counts
- group Id
- OG000
- value
- 190
- group Id
- OG001
- value
- 235
- units
- Participants
- title
- Change at End of Treatment
- denoms
- counts
- group Id
- OG000
- value
- 344
- group Id
- OG001
- value
- 345
- units
- Participants
- description
- Vital signs included blood pressure and pulse rate. Changes from baseline in sitting pulse rate were summarized.
- 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 - Pulse Rate at Day 1 of Cycle 2, 3, 4, 5, 6, 7 and End of Treatment (EOT) Visit
- type
- SECONDARY
- unit Of Measure
- beats per minute
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