NCT03732677 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 533
- group Id
- BG001
- value
- 530
- group Id
- BG002
- value
- 1063
- units
- Participants
- groups
- description
- Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- BG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- description
- Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- BG001
- title
- Gemcitabine + Cisplatin
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.9
- value
- 64.1
- group Id
- BG001
- spread
- 8.9
- value
- 64.6
- group Id
- BG002
- spread
- 8.9
- value
- 64.4
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 96
- group Id
- BG001
- value
- 97
- group Id
- BG002
- value
- 193
- title
- Female
- measurements
- group Id
- BG000
- value
- 437
- group Id
- BG001
- value
- 433
- group Id
- BG002
- value
- 870
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 44
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 85
- title
- HISPANIC OR LATINO
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 18
- title
- MISSING
- categories
- measurements
- group Id
- BG000
- value
- 483
- group Id
- BG001
- value
- 477
- group Id
- BG002
- value
- 960
- title
- NOT HISPANIC OR LATINO
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 152
- group Id
- BG001
- value
- 145
- group Id
- BG002
- value
- 297
- title
- ASIAN
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 10
- title
- BLACK OR AFRICAN AMERICAN
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 36
- title
- MISSING
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 8
- title
- OTHER
- categories
- measurements
- group Id
- BG000
- value
- 354
- group Id
- BG001
- value
- 358
- group Id
- BG002
- value
- 712
- title
- WHITE
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- population Description
- The Full analysis set (FAS) included all randomized participants.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 533
- group Id
- BG001
- value
- 530
- group Id
- BG002
- value
- 1063
- units
- Participants
- groups
- description
- Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- BG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- description
- Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- BG001
- title
- Gemcitabine + Cisplatin
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.9
- value
- 64.1
- group Id
- BG001
- spread
- 8.9
- value
- 64.6
- group Id
- BG002
- spread
- 8.9
- value
- 64.4
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 96
- group Id
- BG001
- value
- 97
- group Id
- BG002
- value
- 193
- title
- Female
- measurements
- group Id
- BG000
- value
- 437
- group Id
- BG001
- value
- 433
- group Id
- BG002
- value
- 870
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 44
- group Id
- BG001
- value
- 41
- group Id
- BG002
- value
- 85
- title
- HISPANIC OR LATINO
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 18
- title
- MISSING
- categories
- measurements
- group Id
- BG000
- value
- 483
- group Id
- BG001
- value
- 477
- group Id
- BG002
- value
- 960
- title
- NOT HISPANIC OR LATINO
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 152
- group Id
- BG001
- value
- 145
- group Id
- BG002
- value
- 297
- title
- ASIAN
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 10
- title
- BLACK OR AFRICAN AMERICAN
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 36
- title
- MISSING
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 8
- title
- OTHER
- categories
- measurements
- group Id
- BG000
- value
- 354
- group Id
- BG001
- value
- 358
- group Id
- BG002
- value
- 712
- title
- WHITE
- param Type
- NUMBER
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- population Description
- The Full analysis set (FAS) included all randomized participants.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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