NCT00553410 · 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
- 2426
- group Id
- BG001
- value
- 2425
- group Id
- BG002
- value
- 4851
- units
- Participants
- groups
- description
- Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
- id
- BG000
- title
- Arm A: Continuous Letrozole
- description
- Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
- id
- BG001
- title
- Arm B: Intermittent Letrozole
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 668
- group Id
- BG001
- value
- 671
- group Id
- BG002
- value
- 1339
- title
- <55
- categories
- measurements
- group Id
- BG000
- value
- 504
- group Id
- BG001
- value
- 496
- group Id
- BG002
- value
- 1000
- title
- 55-59
- categories
- measurements
- group Id
- BG000
- value
- 451
- group Id
- BG001
- value
- 471
- group Id
- BG002
- value
- 922
- title
- 60-64
- categories
- measurements
- group Id
- BG000
- value
- 400
- group Id
- BG001
- value
- 375
- group Id
- BG002
- value
- 775
- title
- 65-69
- categories
- measurements
- group Id
- BG000
- value
- 383
- group Id
- BG001
- value
- 412
- group Id
- BG002
- value
- 795
- title
- 70+
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2426
- group Id
- BG001
- value
- 2425
- group Id
- BG002
- value
- 4851
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2199
- group Id
- BG001
- value
- 2211
- group Id
- BG002
- value
- 4410
- title
- White/Caucasian
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 19
- title
- Black
- categories
- measurements
- group Id
- BG000
- value
- 119
- group Id
- BG001
- value
- 121
- group Id
- BG002
- value
- 240
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 97
- group Id
- BG001
- value
- 83
- group Id
- BG002
- value
- 180
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Unknown
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 77
- group Id
- BG002
- value
- 155
- title
- Hungary
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 40
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 93
- group Id
- BG001
- value
- 99
- group Id
- BG002
- value
- 192
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 217
- group Id
- BG001
- value
- 216
- group Id
- BG002
- value
- 433
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 159
- group Id
- BG001
- value
- 159
- group Id
- BG002
- value
- 318
- title
- Switzerland
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 16
- title
- India
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 43
- title
- Russia
- categories
- measurements
- group Id
- BG000
- value
- 137
- group Id
- BG001
- value
- 134
- group Id
- BG002
- value
- 271
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 19
- title
- New Zealand
- categories
- measurements
- group Id
- BG000
- value
- 88
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 180
- title
- Austria
- categories
- measurements
- group Id
- BG000
- value
- 104
- group Id
- BG001
- value
- 105
- group Id
- BG002
- value
- 209
- title
- Sweden
- categories
- measurements
- group Id
- BG000
- value
- 509
- group Id
- BG001
- value
- 520
- group Id
- BG002
- value
- 1029
- title
- Belgium
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Randomized patients, regardless of eligibility status; exceptions were patients who immediately withdrew consent prior to treatment initiation and declined all participation, patients determined to be without adequate documentation of informed consent, and/or patients at a participating center determined not to be compliant with protocol procedures
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 2426
- group Id
- BG001
- value
- 2425
- group Id
- BG002
- value
- 4851
- units
- Participants
- groups
- description
- Continuous letrozole: 5 years continuously (2.5 mg Letrozole daily) Letrozole: Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
- id
- BG000
- title
- Arm A: Continuous Letrozole
- description
- Intermittent letrozole: 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months Letrozole: Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months
- id
- BG001
- title
- Arm B: Intermittent Letrozole
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 668
- group Id
- BG001
- value
- 671
- group Id
- BG002
- value
- 1339
- title
- <55
- categories
- measurements
- group Id
- BG000
- value
- 504
- group Id
- BG001
- value
- 496
- group Id
- BG002
- value
- 1000
- title
- 55-59
- categories
- measurements
- group Id
- BG000
- value
- 451
- group Id
- BG001
- value
- 471
- group Id
- BG002
- value
- 922
- title
- 60-64
- categories
- measurements
- group Id
- BG000
- value
- 400
- group Id
- BG001
- value
- 375
- group Id
- BG002
- value
- 775
- title
- 65-69
- categories
- measurements
- group Id
- BG000
- value
- 383
- group Id
- BG001
- value
- 412
- group Id
- BG002
- value
- 795
- title
- 70+
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2426
- group Id
- BG001
- value
- 2425
- group Id
- BG002
- value
- 4851
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2199
- group Id
- BG001
- value
- 2211
- group Id
- BG002
- value
- 4410
- title
- White/Caucasian
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 19
- title
- Black
- categories
- measurements
- group Id
- BG000
- value
- 119
- group Id
- BG001
- value
- 121
- group Id
- BG002
- value
- 240
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 97
- group Id
- BG001
- value
- 83
- group Id
- BG002
- value
- 180
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Unknown
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 77
- group Id
- BG002
- value
- 155
- title
- Hungary
- categories
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 40
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 93
- group Id
- BG001
- value
- 99
- group Id
- BG002
- value
- 192
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 217
- group Id
- BG001
- value
- 216
- group Id
- BG002
- value
- 433
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 159
- group Id
- BG001
- value
- 159
- group Id
- BG002
- value
- 318
- title
- Switzerland
- categories
- measurements
- group Id
- BG000
- value
- 8
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 16
- title
- India
- categories
- measurements
- group Id
- BG000
- value
- 22
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 43
- title
- Russia
- categories
- measurements
- group Id
- BG000
- value
- 137
- group Id
- BG001
- value
- 134
- group Id
- BG002
- value
- 271
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 19
- title
- New Zealand
- categories
- measurements
- group Id
- BG000
- value
- 88
- group Id
- BG001
- value
- 92
- group Id
- BG002
- value
- 180
- title
- Austria
- categories
- measurements
- group Id
- BG000
- value
- 104
- group Id
- BG001
- value
- 105
- group Id
- BG002
- value
- 209
- title
- Sweden
- categories
- measurements
- group Id
- BG000
- value
- 509
- group Id
- BG001
- value
- 520
- group Id
- BG002
- value
- 1029
- title
- Belgium
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- population Description
- Randomized patients, regardless of eligibility status; exceptions were patients who immediately withdrew consent prior to treatment initiation and declined all participation, patients determined to be without adequate documentation of informed consent, and/or patients at a participating center determined not to be compliant with protocol procedures
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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