NCT01231906 · 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
- 319
- group Id
- BG001
- value
- 323
- group Id
- BG002
- value
- 642
- units
- Participants
- groups
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
- id
- BG000
- title
- Arm A (Combination Chemotherapy)
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
- id
- BG001
- title
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 272
- group Id
- BG001
- value
- 280
- group Id
- BG002
- value
- 552
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 43
- group Id
- BG002
- value
- 90
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 0
- upper Limit
- 32
- value
- 13
- group Id
- BG001
- lower Limit
- 0
- upper Limit
- 34
- value
- 13
- group Id
- BG002
- lower Limit
- 0
- upper Limit
- 34
- value
- 13
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 145
- group Id
- BG001
- value
- 130
- group Id
- BG002
- value
- 275
- title
- Female
- measurements
- group Id
- BG000
- value
- 174
- group Id
- BG001
- value
- 193
- group Id
- BG002
- value
- 367
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 45
- group Id
- BG001
- value
- 44
- group Id
- BG002
- value
- 89
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 269
- group Id
- BG001
- value
- 275
- group Id
- BG002
- value
- 544
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 9
- 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
- 3
- group Id
- BG002
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 17
- title
- Asian
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 14
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 267
- group Id
- BG001
- value
- 280
- group Id
- BG002
- value
- 547
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 56
- 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
- 286
- group Id
- BG001
- value
- 286
- group Id
- BG002
- value
- 572
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 37
- title
- Australia
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 27
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- title
- New Zealand
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Saudi Arabia
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 319
- group Id
- BG001
- value
- 323
- group Id
- BG002
- value
- 642
- units
- Participants
- groups
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, and 10; doxorubicin hydrochloride IV over 1-15 minutes (or as per institutional policies up to 60-minutes) on days 1 and 2 and cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 5, and 9; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 7, and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7, 8, 9, 10, 13, 14, 17, 18, 21, and 22; doxorubicin hydrochloride IV on days 1 and 2 in weeks 1 and 9; cyclophosphamide IV over 30-60 minutes on day 1 in weeks 1, 7, 9, 13, 17, and 21; and ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 in weeks 3, 5, 11, 15, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 1 and 9.
- id
- BG000
- title
- Arm A (Combination Chemotherapy)
- description
- INDUCTION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 5, 6, 9, 10, 11 and 12; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1 and 9; cyclophosphamide IV over 15-30 minutes on days 1-5 in weeks 1 and 9, and over 30-60 minutes on day 1 of weeks 5 and 11; ifosfamide and etoposide as in arm A; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 5 and 11. CONSOLIDATION THERAPY: Patients receive vincristine sulfate IV on day 1 in weeks 1, 2, 7-10, 13-16, 19, and 20; topotecan hydrochloride IV over 30 minutes on days 1-5 in weeks 1, 7, and 15; cyclophosphamide IV over 15-60 minutes on days 1-5 in weeks 1, 7, and 15, and over 30-60 minutes on day 1 in weeks 9, 13, and 19; ifosfamide IV over 1 hour and etoposide IV over 1- 2 hours on days 1-5 in weeks 3, 5, 11, 17, and 21; and doxorubicin hydrochloride IV on days 1 and 2 in weeks 9,13, and 19. Patients received Dexrazoxane with doxorubicin hydrochloride in weeks 13 and 19.
- id
- BG001
- title
- Arm B (Combination Chemotherapy, Topotecan Hydrochloride)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- value
- 272
- group Id
- BG001
- value
- 280
- group Id
- BG002
- value
- 552
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 47
- group Id
- BG001
- value
- 43
- group Id
- BG002
- value
- 90
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 0
- upper Limit
- 32
- value
- 13
- group Id
- BG001
- lower Limit
- 0
- upper Limit
- 34
- value
- 13
- group Id
- BG002
- lower Limit
- 0
- upper Limit
- 34
- value
- 13
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 145
- group Id
- BG001
- value
- 130
- group Id
- BG002
- value
- 275
- title
- Female
- measurements
- group Id
- BG000
- value
- 174
- group Id
- BG001
- value
- 193
- group Id
- BG002
- value
- 367
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 45
- group Id
- BG001
- value
- 44
- group Id
- BG002
- value
- 89
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 269
- group Id
- BG001
- value
- 275
- group Id
- BG002
- value
- 544
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 9
- 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
- 3
- group Id
- BG002
- value
- 3
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 17
- title
- Asian
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 5
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 14
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 267
- group Id
- BG001
- value
- 280
- group Id
- BG002
- value
- 547
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 28
- group Id
- BG001
- value
- 28
- group Id
- BG002
- value
- 56
- 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
- 286
- group Id
- BG001
- value
- 286
- group Id
- BG002
- value
- 572
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 17
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 37
- title
- Australia
- categories
- measurements
- group Id
- BG000
- value
- 14
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 27
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 4
- title
- New Zealand
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 2
- title
- Saudi Arabia
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
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