NCT03215030 · 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
- 20
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 25
- group Id
- BG007
- value
- 25
- group Id
- BG008
- value
- 71
- group Id
- BG009
- value
- 75
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- units
- Participants
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG003
- title
- Part 1 (Dose Escalation) Schedule D
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG004
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG005
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG006
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG007
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG008
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG009
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- description
- Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG010
- title
- Japan Lead-in: Modakafusp Alfa 60 mg
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG011
- title
- Japan Lead-in: Modakafusp Alfa 120 mg
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.56
- value
- 60.3
- group Id
- BG001
- spread
- 7.00
- value
- 61.1
- group Id
- BG002
- spread
- 10.47
- value
- 60.4
- group Id
- BG003
- spread
- 10.34
- value
- 64.7
- group Id
- BG004
- spread
- 8.63
- value
- 61.9
- group Id
- BG005
- spread
- 12.58
- value
- 65.7
- group Id
- BG006
- spread
- 12.17
- value
- 64.1
- group Id
- BG007
- spread
- 7.77
- value
- 70.2
- group Id
- BG008
- spread
- 9.76
- value
- 66.2
- group Id
- BG009
- spread
- 9.61
- value
- 66.5
- group Id
- BG010
- spread
- 9.71
- value
- 66.66
- group Id
- BG011
- spread
- 11.31
- value
- 66.00
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 10
- group Id
- BG008
- value
- 34
- group Id
- BG009
- value
- 39
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 15
- group Id
- BG008
- value
- 37
- group Id
- BG009
- value
- 36
- 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
- 1
- 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
- 1
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 24
- group Id
- BG007
- value
- 23
- group Id
- BG008
- value
- 51
- group Id
- BG009
- value
- 57
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- 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
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 16
- group Id
- BG009
- value
- 15
- group Id
- BG010
- value
- 0
- 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
- 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
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 5
- group Id
- BG009
- value
- 9
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 8
- group Id
- BG008
- value
- 10
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 14
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 20
- group Id
- BG007
- value
- 17
- group Id
- BG008
- value
- 38
- group Id
- BG009
- value
- 51
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- 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
- group Id
- BG011
- value
- 0
- title
- More than one race
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 18
- group Id
- BG009
- value
- 11
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Parts 1 and 2: The Safety Analysis Set (SAS) included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Part 3 and Japan Lead-in: The Full Analysis Set (FAS) included all enrolled participants who received at least 1 dose of study drug even if dose was incomplete.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 25
- group Id
- BG007
- value
- 25
- group Id
- BG008
- value
- 71
- group Id
- BG009
- value
- 75
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- units
- Participants
- groups
- description
- Participants received modakafusp alfa 0.001 up to 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by Q2W on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG000
- title
- Part 1 (Dose Escalation) Schedule A
- description
- Participants received modakafusp alfa 0.20 up to 0.30 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG001
- title
- Part 1 (Dose Escalation) Schedule B
- description
- Participants received modakafusp alfa 0.40 up to 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG002
- title
- Part 1 (Dose Escalation) Schedule C
- description
- Participants received modakafusp alfa 1.5 up to 6.0 mg/kg, infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG003
- title
- Part 1 (Dose Escalation) Schedule D
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG004
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- BG005
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG006
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- BG007
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG008
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG009
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- description
- Participants received modakafusp alfa 60 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG010
- title
- Japan Lead-in: Modakafusp Alfa 60 mg
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- BG011
- title
- Japan Lead-in: Modakafusp Alfa 120 mg
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.56
- value
- 60.3
- group Id
- BG001
- spread
- 7.00
- value
- 61.1
- group Id
- BG002
- spread
- 10.47
- value
- 60.4
- group Id
- BG003
- spread
- 10.34
- value
- 64.7
- group Id
- BG004
- spread
- 8.63
- value
- 61.9
- group Id
- BG005
- spread
- 12.58
- value
- 65.7
- group Id
- BG006
- spread
- 12.17
- value
- 64.1
- group Id
- BG007
- spread
- 7.77
- value
- 70.2
- group Id
- BG008
- spread
- 9.76
- value
- 66.2
- group Id
- BG009
- spread
- 9.61
- value
- 66.5
- group Id
- BG010
- spread
- 9.71
- value
- 66.66
- group Id
- BG011
- spread
- 11.31
- value
- 66.00
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 10
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 10
- group Id
- BG008
- value
- 34
- group Id
- BG009
- value
- 39
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 10
- group Id
- BG001
- value
- 5
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 7
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 13
- group Id
- BG007
- value
- 15
- group Id
- BG008
- value
- 37
- group Id
- BG009
- value
- 36
- 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
- 1
- 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
- 1
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 3
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 24
- group Id
- BG007
- value
- 23
- group Id
- BG008
- value
- 51
- group Id
- BG009
- value
- 57
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- 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
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 16
- group Id
- BG009
- value
- 15
- group Id
- BG010
- value
- 0
- 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
- 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
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 5
- group Id
- BG009
- value
- 9
- group Id
- BG010
- value
- 3
- group Id
- BG011
- value
- 2
- 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
- 0
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 0
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 5
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 8
- group Id
- BG008
- value
- 10
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 20
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 14
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 20
- group Id
- BG007
- value
- 17
- group Id
- BG008
- value
- 38
- group Id
- BG009
- value
- 51
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- 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
- group Id
- BG011
- value
- 0
- title
- More than one race
- 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
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 18
- group Id
- BG009
- value
- 11
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- Parts 1 and 2: The Safety Analysis Set (SAS) included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. Part 3 and Japan Lead-in: The Full Analysis Set (FAS) included all enrolled participants who received at least 1 dose of study drug even if dose was incomplete.
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Preserved source evidence · Not medical advice
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