NCT04209465 · 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
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 18
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 5
- units
- Participants
- groups
- description
- Patients who received doses at 25 mg once daily under fasted conditions.
- id
- BG000
- title
- Dose Escalation 25 mg QD
- description
- Patients who received doses at 50 mg once daily under fasted conditions.
- id
- BG001
- title
- Dose Escalation 50 mg QD
- description
- Patients who received doses at 100 mg once daily under fasted conditions.
- id
- BG002
- title
- Dose Escalation 100 mg QD
- description
- Patients who received doses at 200 mg once daily under fasted conditions.
- id
- BG003
- title
- Dose Escalation 200 mg QD
- description
- Patients who received 400 mg once daily under fasted conditions.
- id
- BG004
- title
- Dose Escalation 400 mg QD
- description
- Patients who received 800 mg once daily under fasted conditions.
- id
- BG005
- title
- Dose Escalation 800 mg QD
- description
- Patients who received 800 mg once daily under not fasted conditions.
- id
- BG006
- title
- Dose Escalation 800 mg QD NF
- description
- Patients who received 1000 mg once daily under not fasted conditions
- id
- BG007
- title
- Dose Escalation 1000 mg QD
- description
- Patients who received 1200 mg once daily under fasted conditions.
- id
- BG008
- title
- Dose Escalation 1200 mg QD
- description
- Patients who received 400 mg twice daily under not fasted conditions.
- id
- BG009
- title
- Dose Escalation 400 mg BID
- description
- Patients who received 600 mg twice daily under not fasted conditions.
- id
- BG010
- title
- Dose Escalation 600 mg BID
- description
- Patients who received 800 mg twice daily under fasted conditions.
- id
- BG011
- title
- Dose Escalation 800 mg BID
- measures
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- <=18 years
- 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
- 4
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 5
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 51
- group Id
- BG003
- spread
- 17.0
- value
- 60
- group Id
- BG004
- spread
- 9.48
- value
- 64.5
- group Id
- BG005
- spread
- 11.94
- value
- 65.4
- group Id
- BG006
- spread
- 7.00
- value
- 60.2
- group Id
- BG007
- spread
- 7.00
- value
- 61.4
- group Id
- BG008
- spread
- 6.59
- value
- 55.8
- group Id
- BG009
- spread
- 6.06
- value
- 71.0
- group Id
- BG010
- spread
- 11.99
- value
- 59.3
- group Id
- BG011
- spread
- 5.70
- value
- 58.0
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 5
- group Id
- BG011
- value
- 3
- title
- Female
- 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
- 5
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 2
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- 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
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 15
- group Id
- BG006
- value
- 11
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 5
- title
- Not Hispanic or Latino
- 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
- 1
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- 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
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 18
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 5
- title
- United States
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 18
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 5
- units
- Participants
- groups
- description
- Patients who received doses at 25 mg once daily under fasted conditions.
- id
- BG000
- title
- Dose Escalation 25 mg QD
- description
- Patients who received doses at 50 mg once daily under fasted conditions.
- id
- BG001
- title
- Dose Escalation 50 mg QD
- description
- Patients who received doses at 100 mg once daily under fasted conditions.
- id
- BG002
- title
- Dose Escalation 100 mg QD
- description
- Patients who received doses at 200 mg once daily under fasted conditions.
- id
- BG003
- title
- Dose Escalation 200 mg QD
- description
- Patients who received 400 mg once daily under fasted conditions.
- id
- BG004
- title
- Dose Escalation 400 mg QD
- description
- Patients who received 800 mg once daily under fasted conditions.
- id
- BG005
- title
- Dose Escalation 800 mg QD
- description
- Patients who received 800 mg once daily under not fasted conditions.
- id
- BG006
- title
- Dose Escalation 800 mg QD NF
- description
- Patients who received 1000 mg once daily under not fasted conditions
- id
- BG007
- title
- Dose Escalation 1000 mg QD
- description
- Patients who received 1200 mg once daily under fasted conditions.
- id
- BG008
- title
- Dose Escalation 1200 mg QD
- description
- Patients who received 400 mg twice daily under not fasted conditions.
- id
- BG009
- title
- Dose Escalation 400 mg BID
- description
- Patients who received 600 mg twice daily under not fasted conditions.
- id
- BG010
- title
- Dose Escalation 600 mg BID
- description
- Patients who received 800 mg twice daily under fasted conditions.
- id
- BG011
- title
- Dose Escalation 800 mg BID
- measures
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- <=18 years
- 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
- 4
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 10
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 5
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 0
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- group Id
- BG001
- value
- 65
- group Id
- BG002
- value
- 51
- group Id
- BG003
- spread
- 17.0
- value
- 60
- group Id
- BG004
- spread
- 9.48
- value
- 64.5
- group Id
- BG005
- spread
- 11.94
- value
- 65.4
- group Id
- BG006
- spread
- 7.00
- value
- 60.2
- group Id
- BG007
- spread
- 7.00
- value
- 61.4
- group Id
- BG008
- spread
- 6.59
- value
- 55.8
- group Id
- BG009
- spread
- 6.06
- value
- 71.0
- group Id
- BG010
- spread
- 11.99
- value
- 59.3
- group Id
- BG011
- spread
- 5.70
- value
- 58.0
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 9
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 5
- group Id
- BG011
- value
- 3
- title
- Female
- 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
- 5
- group Id
- BG005
- value
- 9
- group Id
- BG006
- value
- 4
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 2
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- 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
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 2
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 15
- group Id
- BG006
- value
- 11
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 5
- title
- Not Hispanic or Latino
- 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
- 1
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- 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
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 10
- group Id
- BG005
- value
- 18
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 7
- group Id
- BG008
- value
- 6
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 5
- title
- United States
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Spain
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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