NCT02998528 · 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
- 213
- group Id
- BG002
- value
- 179
- group Id
- BG003
- value
- 505
- units
- Participants
- groups
- description
- Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG000
- title
- Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
- description
- Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG001
- title
- Arm B: Platinum Doublet Chemo
- description
- Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG002
- title
- Arm C: Nivo 360 mg + Platinum Doublet Chemo
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 62
- group Id
- BG001
- value
- 99
- group Id
- BG002
- value
- 93
- group Id
- BG003
- value
- 254
- title
- < 65
- categories
- measurements
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 96
- group Id
- BG002
- value
- 75
- group Id
- BG003
- value
- 211
- title
- >= 65 AND < 75
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 39
- title
- >= 75 AND < 85
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- >= 85
- param Type
- NUMBER
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 51
- group Id
- BG003
- value
- 156
- title
- Female
- measurements
- group Id
- BG000
- value
- 73
- group Id
- BG001
- value
- 148
- group Id
- BG002
- value
- 128
- group Id
- BG003
- value
- 349
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 7
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 53
- group Id
- BG001
- value
- 105
- group Id
- BG002
- value
- 100
- group Id
- BG003
- value
- 258
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 103
- group Id
- BG002
- value
- 79
- group Id
- BG003
- value
- 240
- 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
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 96
- group Id
- BG002
- value
- 86
- group Id
- BG003
- value
- 223
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 13
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 64
- group Id
- BG001
- value
- 108
- group Id
- BG002
- value
- 89
- group Id
- BG003
- value
- 261
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 8
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All randomized participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 113
- group Id
- BG001
- value
- 213
- group Id
- BG002
- value
- 179
- group Id
- BG003
- value
- 505
- units
- Participants
- groups
- description
- Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes. Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG000
- title
- Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg
- description
- Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG001
- title
- Arm B: Platinum Doublet Chemo
- description
- Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days). Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.
- id
- BG002
- title
- Arm C: Nivo 360 mg + Platinum Doublet Chemo
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 62
- group Id
- BG001
- value
- 99
- group Id
- BG002
- value
- 93
- group Id
- BG003
- value
- 254
- title
- < 65
- categories
- measurements
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 96
- group Id
- BG002
- value
- 75
- group Id
- BG003
- value
- 211
- title
- >= 65 AND < 75
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 39
- title
- >= 75 AND < 85
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- title
- >= 85
- param Type
- NUMBER
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 51
- group Id
- BG003
- value
- 156
- title
- Female
- measurements
- group Id
- BG000
- value
- 73
- group Id
- BG001
- value
- 148
- group Id
- BG002
- value
- 128
- group Id
- BG003
- value
- 349
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 7
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 53
- group Id
- BG001
- value
- 105
- group Id
- BG002
- value
- 100
- group Id
- BG003
- value
- 258
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 58
- group Id
- BG001
- value
- 103
- group Id
- BG002
- value
- 79
- group Id
- BG003
- value
- 240
- 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
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 96
- group Id
- BG002
- value
- 86
- group Id
- BG003
- value
- 223
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 13
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 64
- group Id
- BG001
- value
- 108
- group Id
- BG002
- value
- 89
- group Id
- BG003
- value
- 261
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 8
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All randomized participants
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Preserved source evidence · Not medical advice
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