NCT04334759 · 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
- 113
- group Id
- BG001
- value
- 60
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 23
- group Id
- BG004
- value
- 213
- units
- Participants
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- BG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
- id
- BG001
- title
- Control Arm: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- BG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
- id
- BG003
- title
- Control Arm: Ipilimumab and Nivolumab
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 13
- group Id
- BG004
- value
- 86
- title
- 18-70
- categories
- measurements
- group Id
- BG000
- value
- 72
- group Id
- BG001
- value
- 38
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 127
- title
- Above 70
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 44
- title
- Female
- measurements
- group Id
- BG000
- value
- 96
- group Id
- BG001
- value
- 49
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 13
- group Id
- BG004
- value
- 169
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 100
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 19
- group Id
- BG004
- value
- 186
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 27
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 109
- group Id
- BG001
- value
- 57
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 22
- group Id
- BG004
- value
- 203
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 5
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 75
- group Id
- BG001
- value
- 43
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 146
- title
- Australia
- categories
- measurements
- group Id
- BG000
- value
- 38
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 67
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
- population Description
- One patient in the experimental arm of the Chemo Cohort was excluded due to a randomization error, with no treatment or follow-up data available.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 60
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 23
- group Id
- BG004
- value
- 213
- units
- Participants
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- BG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
- id
- BG001
- title
- Control Arm: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- BG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
- id
- BG003
- title
- Control Arm: Ipilimumab and Nivolumab
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 22
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 13
- group Id
- BG004
- value
- 86
- title
- 18-70
- categories
- measurements
- group Id
- BG000
- value
- 72
- group Id
- BG001
- value
- 38
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 127
- title
- Above 70
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 44
- title
- Female
- measurements
- group Id
- BG000
- value
- 96
- group Id
- BG001
- value
- 49
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 13
- group Id
- BG004
- value
- 169
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 100
- group Id
- BG001
- value
- 55
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 19
- group Id
- BG004
- value
- 186
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 27
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 5
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 109
- group Id
- BG001
- value
- 57
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 22
- group Id
- BG004
- value
- 203
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 5
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 75
- group Id
- BG001
- value
- 43
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 146
- title
- Australia
- categories
- measurements
- group Id
- BG000
- value
- 38
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 67
- title
- United States
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
- population Description
- One patient in the experimental arm of the Chemo Cohort was excluded due to a randomization error, with no treatment or follow-up data available.
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
Triangle