NCT03157128 · 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
- 6
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 19
- group Id
- BG007
- value
- 764
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 857
- units
- Participants
- groups
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG000
- title
- Phase 1: 20 mg Selpercatinib QD
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG001
- title
- Phase 1: 20 mg Selpercatinib BID
- description
- Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG002
- title
- Phase 1: 40 mg Selpercatinib BID
- description
- Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG003
- title
- Phase 1: 60 mg Selpercatinib BID
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG004
- title
- Phase 1: 160 mg Selpercatinib QD
- description
- Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG005
- title
- Phase 1: 80 mg Selpercatinib BID
- description
- Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG006
- title
- Phase 1: 120 mg Selpercatinib BID
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG007
- title
- Phase 1: 160 mg Selpercatinib BID
- description
- Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG008
- title
- Phase 1: 200 mg Selpercatinib BID
- description
- Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG009
- title
- Phase 1: 240 mg Selpercatinib BID
- description
- Total of all reporting groups
- id
- BG010
- title
- Total
- measures
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 3
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 495
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 556
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 267
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 298
- 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
- 4
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 378
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 421
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 13
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 386
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 436
- 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
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 38
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 40
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 18
- group Id
- BG007
- value
- 700
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 790
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 26
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 27
- 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
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 198
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 207
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 24
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 27
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 16
- group Id
- BG006
- value
- 15
- group Id
- BG007
- value
- 502
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 580
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 36
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 39
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All enrolled Participants.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 16
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 19
- group Id
- BG007
- value
- 764
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 857
- units
- Participants
- groups
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG000
- title
- Phase 1: 20 mg Selpercatinib QD
- description
- Participants received Selpercatinib 20 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG001
- title
- Phase 1: 20 mg Selpercatinib BID
- description
- Participants received Selpercatinib 40 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG002
- title
- Phase 1: 40 mg Selpercatinib BID
- description
- Participants received Selpercatinib 60 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG003
- title
- Phase 1: 60 mg Selpercatinib BID
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally once daily (QD), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG004
- title
- Phase 1: 160 mg Selpercatinib QD
- description
- Participants received Selpercatinib 80 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG005
- title
- Phase 1: 80 mg Selpercatinib BID
- description
- Participants received Selpercatinib 120 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG006
- title
- Phase 1: 120 mg Selpercatinib BID
- description
- Participants received Selpercatinib 160 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG007
- title
- Phase 1: 160 mg Selpercatinib BID
- description
- Participants received Selpercatinib 200 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG008
- title
- Phase 1: 200 mg Selpercatinib BID
- description
- Participants received Selpercatinib 240 milligrams (mg) administered orally twice daily (BID), in a 28-day treatment cycle. Treatment was continued until disease progression, unacceptable toxicity, or treatment discontinuation for other reasons.
- id
- BG009
- title
- Phase 1: 240 mg Selpercatinib BID
- description
- Total of all reporting groups
- id
- BG010
- title
- Total
- measures
- calculate Pct
- false
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 3
- title
- <=18 years
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 11
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 495
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 556
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 8
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 267
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 298
- 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
- 4
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 7
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 378
- group Id
- BG008
- value
- 1
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 421
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 13
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 386
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 2
- group Id
- BG010
- value
- 436
- 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
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 38
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 40
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 6
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 12
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 20
- group Id
- BG006
- value
- 18
- group Id
- BG007
- value
- 700
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 790
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 26
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 27
- 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
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 198
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 207
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 2
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 24
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 27
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 16
- group Id
- BG006
- value
- 15
- group Id
- BG007
- value
- 502
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 5
- group Id
- BG010
- value
- 580
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 36
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 39
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- All enrolled Participants.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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