NCT03386513 · 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
- 3
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 104
- group Id
- BG010
- value
- 10
- group Id
- BG011
- value
- 179
- units
- Participants
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG009
- title
- Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG010
- title
- Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
- description
- Total of all reporting groups
- id
- BG011
- title
- Total
- 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
- 2
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 34
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 58
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 10
- group Id
- BG009
- value
- 70
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 121
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 17
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 53
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 11
- group Id
- BG009
- value
- 87
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 126
- 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
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- 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
- 13
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 19
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 85
- group Id
- BG010
- value
- 8
- group Id
- BG011
- value
- 151
- title
- Not Hispanic or Latino
- 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
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 0
- group Id
- BG011
- 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
- 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
- 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
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 0
- 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
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- 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
- 1
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 10
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 13
- group Id
- BG009
- value
- 86
- group Id
- BG010
- value
- 9
- group Id
- BG011
- value
- 154
- 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
- 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
- 13
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 13
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- The safety population included all participants who received at least 1 dose of study drug.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 13
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 104
- group Id
- BG010
- value
- 10
- group Id
- BG011
- value
- 179
- units
- Participants
- groups
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG000
- title
- Dose Escalation - Schedule A: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG001
- title
- Dose Escalation - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG002
- title
- Dose Escalation - Schedule A: IMGN632 0.09 mg/kg
- description
- Participants received IMGN632 at a dose of 0.18 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG003
- title
- Dose Escalation - Schedule A: IMGN632 0.18 mg/kg
- description
- Participants received IMGN632 at a dose of 0.3 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG004
- title
- Dose Escalation - Schedule A: IMGN632 0.3 mg/kg
- description
- Participants received IMGN632 at a dose of 0.45 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG005
- title
- Dose Escalation - Schedule A: IMGN632 0.45 mg/kg
- description
- Participants received IMGN632 at a dose of 0.015 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG006
- title
- Dose Escalation - Schedule B: IMGN632 0.015 mg/kg
- description
- Participants received IMGN632 at a dose of 0.03 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG007
- title
- Dose Escalation - Schedule B: IMGN632 0.03 mg/kg
- description
- Participants received IMGN632 at a dose of 0.06 mg/kg via IV infusion on Days 1, 4, and 8 of each 21-day cycle.
- id
- BG008
- title
- Dose Escalation - Schedule B: IMGN632 0.06 mg/kg
- description
- Participants received IMGN632 at a dose of 0.045 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG009
- title
- Dose Expansion - Schedule A: IMGN632 0.045 mg/kg
- description
- Participants received IMGN632 at a dose of 0.09 mg/kg via IV infusion on Day 1 of each 21-day cycle.
- id
- BG010
- title
- Dose Expansion - Schedule A: IMGN632 0.09 mg/kg
- description
- Total of all reporting groups
- id
- BG011
- title
- Total
- 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
- 2
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 0
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 34
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 58
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 6
- group Id
- BG008
- value
- 10
- group Id
- BG009
- value
- 70
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 121
- title
- >=65 years
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Age, Categorical
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 1
- group Id
- BG007
- value
- 4
- group Id
- BG008
- value
- 3
- group Id
- BG009
- value
- 17
- group Id
- BG010
- value
- 4
- group Id
- BG011
- value
- 53
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 2
- group Id
- BG008
- value
- 11
- group Id
- BG009
- value
- 87
- group Id
- BG010
- value
- 6
- group Id
- BG011
- value
- 126
- 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
- 2
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- 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
- 13
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 19
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 2
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 85
- group Id
- BG010
- value
- 8
- group Id
- BG011
- value
- 151
- title
- Not Hispanic or Latino
- 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
- 1
- group Id
- BG008
- value
- 0
- group Id
- BG009
- value
- 6
- group Id
- BG010
- value
- 0
- group Id
- BG011
- 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
- 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
- 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
- 0
- group Id
- BG009
- value
- 1
- group Id
- BG010
- value
- 0
- 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
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 3
- 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
- 1
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 10
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 12
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 3
- group Id
- BG007
- value
- 5
- group Id
- BG008
- value
- 13
- group Id
- BG009
- value
- 86
- group Id
- BG010
- value
- 9
- group Id
- BG011
- value
- 154
- 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
- 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
- 13
- group Id
- BG010
- value
- 0
- group Id
- BG011
- value
- 13
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- population Description
- The safety population included all participants who received at least 1 dose of study drug.
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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