NCT03523585 · 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
- 406
- group Id
- BG001
- value
- 91
- group Id
- BG002
- value
- 111
- group Id
- BG003
- value
- 608
- units
- Participants
- groups
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- BG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.
- id
- BG001
- title
- Trastuzumab+Capecitabine
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
- id
- BG002
- title
- Lapatinib+Capecitabine
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 321
- group Id
- BG001
- value
- 73
- group Id
- BG002
- value
- 91
- group Id
- BG003
- value
- 485
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 85
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 123
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 11.99
- value
- 54.6
- group Id
- BG001
- spread
- 11.40
- value
- 55.7
- group Id
- BG002
- spread
- 11.06
- value
- 54.6
- group Id
- BG003
- spread
- 11.73
- value
- 54.8
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 403
- group Id
- BG001
- value
- 89
- group Id
- BG002
- value
- 111
- group Id
- BG003
- value
- 603
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- 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
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 122
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 36
- group Id
- BG003
- value
- 178
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 17
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 257
- group Id
- BG001
- value
- 66
- group Id
- BG002
- value
- 61
- group Id
- BG003
- value
- 384
- 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
- 15
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 26
- 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
- 41
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 64
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- title
- Czechia
- categories
- measurements
- group Id
- BG000
- value
- 46
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 18
- group Id
- BG003
- value
- 70
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 35
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 44
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 14
- title
- Greece
- categories
- measurements
- group Id
- BG000
- value
- 66
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 94
- title
- South Korea
- categories
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 52
- title
- Turkey
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- title
- Belgium
- categories
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 59
- title
- Brazil
- categories
- measurements
- group Id
- BG000
- value
- 33
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 53
- title
- Italy
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 18
- title
- Israel
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Baseline characteristics were assessed using the Full Analysis Set.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 406
- group Id
- BG001
- value
- 91
- group Id
- BG002
- value
- 111
- group Id
- BG003
- value
- 608
- units
- Participants
- groups
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received T-DXd as a sterile intravenous (IV) solution at a dose of 5.4 mg/kg every 3 weeks (Q3W).
- id
- BG000
- title
- Trastuzumab Deruxtecan (T-DXd)
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Trastuzumab/Capecitabine.
- id
- BG001
- title
- Trastuzumab+Capecitabine
- description
- Participants with HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), who received investigator's choice treatment, Lapatinib/Capecitabine.
- id
- BG002
- title
- Lapatinib+Capecitabine
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 321
- group Id
- BG001
- value
- 73
- group Id
- BG002
- value
- 91
- group Id
- BG003
- value
- 485
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 85
- group Id
- BG001
- value
- 18
- group Id
- BG002
- value
- 20
- group Id
- BG003
- value
- 123
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 11.99
- value
- 54.6
- group Id
- BG001
- spread
- 11.40
- value
- 55.7
- group Id
- BG002
- spread
- 11.06
- value
- 54.6
- group Id
- BG003
- spread
- 11.73
- value
- 54.8
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 403
- group Id
- BG001
- value
- 89
- group Id
- BG002
- value
- 111
- group Id
- BG003
- value
- 603
- title
- Female
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- 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
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 122
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 36
- group Id
- BG003
- value
- 178
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 17
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 257
- group Id
- BG001
- value
- 66
- group Id
- BG002
- value
- 61
- group Id
- BG003
- value
- 384
- 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
- 15
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 26
- 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
- 41
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 64
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 3
- title
- Czechia
- categories
- measurements
- group Id
- BG000
- value
- 46
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 18
- group Id
- BG003
- value
- 70
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 35
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 29
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 44
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 14
- title
- Greece
- categories
- measurements
- group Id
- BG000
- value
- 66
- group Id
- BG001
- value
- 11
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 94
- title
- South Korea
- categories
- measurements
- group Id
- BG000
- value
- 36
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 52
- title
- Turkey
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 5
- title
- Belgium
- categories
- measurements
- group Id
- BG000
- value
- 41
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 59
- title
- Brazil
- categories
- measurements
- group Id
- BG000
- value
- 33
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 17
- group Id
- BG003
- value
- 53
- title
- Italy
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 4
- group Id
- BG003
- value
- 18
- title
- Israel
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Baseline characteristics were assessed using the Full Analysis Set.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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