NCT04211337 · 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
- 193
- group Id
- BG001
- value
- 98
- group Id
- BG002
- value
- 291
- units
- Participants
- groups
- description
- 160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
- id
- BG000
- title
- Selpercatinib (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- BG001
- title
- Cabozantinib or Vandetanib (TRT B)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 143
- group Id
- BG001
- value
- 72
- group Id
- BG002
- value
- 215
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 49
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 75
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 108
- title
- Female
- measurements
- group Id
- BG000
- value
- 115
- group Id
- BG001
- value
- 68
- group Id
- BG002
- value
- 183
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 181
- group Id
- BG001
- value
- 94
- group Id
- BG002
- value
- 275
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 43
- group Id
- BG001
- value
- 24
- group Id
- BG002
- value
- 67
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 116
- group Id
- BG001
- value
- 52
- group Id
- BG002
- value
- 168
- 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
- 29
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 49
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 15
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 6
- title
- Czechia
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 11
- title
- India
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 21
- title
- Russia
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Greece
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 9
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 12
- title
- South Korea
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Belgium
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
- population Description
- All randomized participants, even if a participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 193
- group Id
- BG001
- value
- 98
- group Id
- BG002
- value
- 291
- units
- Participants
- groups
- description
- 160 milligrams Selpercatinib administered orally (PO) twice daily (BID). Adolescent Dose: 92 mg/m2 BID (not to exceed 160 mg BID).
- id
- BG000
- title
- Selpercatinib (TRT A)
- description
- 140 mg Cabozantinib administered orally daily (QD) or 300 mg Vandetanib administered orally QD per physician choice. Cabozantinib Adolescent Dose: 40 mg/m2. Vandetanib Adolescent Dose: * 0.7 - \<0.9 - 100 mg every other day (QOD) * 0.9 - \<1.2 - 100 mg QD * 1.2 - \<1.6 - 7-day schedule 100 mg - 200 mg - 100 mg - 200 mg - 100 mg - 200 mg - 100 mg * ≥1.6 - 200 QD
- id
- BG001
- title
- Cabozantinib or Vandetanib (TRT B)
- description
- Total of all reporting groups
- id
- BG002
- title
- Total
- measures
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 143
- group Id
- BG001
- value
- 72
- group Id
- BG002
- value
- 215
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 49
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 75
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 78
- group Id
- BG001
- value
- 30
- group Id
- BG002
- value
- 108
- title
- Female
- measurements
- group Id
- BG000
- value
- 115
- group Id
- BG001
- value
- 68
- group Id
- BG002
- value
- 183
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 181
- group Id
- BG001
- value
- 94
- group Id
- BG002
- value
- 275
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 43
- group Id
- BG001
- value
- 24
- group Id
- BG002
- value
- 67
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 116
- group Id
- BG001
- value
- 52
- group Id
- BG002
- value
- 168
- 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
- 29
- group Id
- BG001
- value
- 20
- group Id
- BG002
- value
- 49
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 15
- title
- United States
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 6
- title
- Czechia
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 6
- title
- Japan
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- United Kingdom
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 11
- title
- India
- categories
- measurements
- group Id
- BG000
- value
- 15
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 21
- title
- Russia
- categories
- measurements
- group Id
- BG000
- value
- 9
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 12
- title
- Spain
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 4
- title
- Greece
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- title
- Canada
- categories
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 9
- title
- Netherlands
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 12
- title
- South Korea
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- title
- Belgium
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Region of Enrollment
- unit Of Measure
- Participants
- population Description
- All randomized participants, even if a participant does not take the assigned treatment, does not receive the correct treatment, or otherwise does not follow the protocol.
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Preserved source evidence · Not medical advice
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