NCT02418000 · 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
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 27
- units
- Participants
- groups
- description
- Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinued, and followed for up to 6 months after the last dose.
- id
- BG000
- title
- Cohort 1: E6201 240 mg/m^2 Weekly
- description
- Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG001
- title
- Cohort 2: E6201 320 mg/m^2 Weekly
- description
- Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG002
- title
- Cohort 3: E6201 160 mg/m^2 Twice Weekly
- description
- Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG003
- title
- Cohort 4: E6201 240 mg/m^2 Twice Weekly
- description
- Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG004
- title
- Cohort 5: E6201 320 mg/m^2 Twice Weekly
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 13.97
- value
- 61.57
- group Id
- BG001
- spread
- 19.14
- value
- 51.10
- group Id
- BG002
- spread
- 11.02
- value
- 61.33
- group Id
- BG003
- spread
- 12.01
- value
- 56.33
- group Id
- BG004
- spread
- 17.64
- value
- 56.00
- group Id
- BG005
- spread
- 15.78
- value
- 56.26
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 14
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 13
- 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
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 21
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- 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
- 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
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 19
- title
- White
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- 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
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 27
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 24
- title
- AML
- measurements
- group Id
- BG000
- value
- 1
- 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
- title
- MDS
- measurements
- group Id
- BG000
- value
- 2
- 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
- title
- CMML
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Disease Type
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- 0
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 20
- title
- 1
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- title
- 2
- 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
- title
- 3
- 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
- title
- 4
- description
- ECOG Performance Status: 0 = Fully active, able to carry on all pre-disease performance without restriction 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. = Dead
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Eastern Cooperative Group (ECOG) Performance Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 2
- upper Limit
- 8
- value
- 3
- group Id
- BG001
- lower Limit
- 4
- upper Limit
- 14
- value
- 6.5
- group Id
- BG002
- lower Limit
- 4
- upper Limit
- 7
- value
- 4
- group Id
- BG003
- lower Limit
- 4
- upper Limit
- 10
- value
- 5
- group Id
- BG004
- lower Limit
- 4
- upper Limit
- 11
- value
- 4
- group Id
- BG005
- lower Limit
- 2
- upper Limit
- 14
- value
- 5
- title
- All Prior Cancer Treatment Regimens
- categories
- measurements
- group Id
- BG000
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG001
- lower Limit
- 1
- upper Limit
- 3
- value
- 1
- group Id
- BG002
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG003
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG004
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG005
- lower Limit
- 1
- upper Limit
- 3
- value
- 1
- title
- Prior FLT3 Inhibitor Treatment Regimens
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Prior Cancer Therapies
- unit Of Measure
- Number of treatment regimens
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 27
- units
- Participants
- groups
- description
- Cohort 1: Participants were administered E6201 240 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinued, and followed for up to 6 months after the last dose.
- id
- BG000
- title
- Cohort 1: E6201 240 mg/m^2 Weekly
- description
- Cohort 2: Participants were administered E6201 320 mg/m\^2 IV over 2 hours once weekly, on Days 1, 8, 15, and 22, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG001
- title
- Cohort 2: E6201 320 mg/m^2 Weekly
- description
- Cohort 3: Participants were administered E6201 160 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG002
- title
- Cohort 3: E6201 160 mg/m^2 Twice Weekly
- description
- Cohort 4: Participants were administered E6201 240 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG003
- title
- Cohort 4: E6201 240 mg/m^2 Twice Weekly
- description
- Cohort 5: Participants were administered E6201 320 mg/m\^2 IV over 2 hours twice weekly, on Days 1, 4, 8, 11, 15, 18, 22 and 25, repeated every 28 days (= 1 cycle) until progression of disease, toxicity or other reason for study drug discontinuation, and followed for up to 6 months after the last dose.
- id
- BG004
- title
- Cohort 5: E6201 320 mg/m^2 Twice Weekly
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 13.97
- value
- 61.57
- group Id
- BG001
- spread
- 19.14
- value
- 51.10
- group Id
- BG002
- spread
- 11.02
- value
- 61.33
- group Id
- BG003
- spread
- 12.01
- value
- 56.33
- group Id
- BG004
- spread
- 17.64
- value
- 56.00
- group Id
- BG005
- spread
- 15.78
- value
- 56.26
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 14
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 13
- 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
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 8
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 21
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- 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
- 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
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 19
- title
- White
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 2
- 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
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 7
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 27
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 10
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 24
- title
- AML
- measurements
- group Id
- BG000
- value
- 1
- 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
- title
- MDS
- measurements
- group Id
- BG000
- value
- 2
- 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
- title
- CMML
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Disease Type
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 3
- title
- 0
- measurements
- group Id
- BG000
- value
- 5
- group Id
- BG001
- value
- 6
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 20
- title
- 1
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 4
- title
- 2
- 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
- title
- 3
- 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
- title
- 4
- description
- ECOG Performance Status: 0 = Fully active, able to carry on all pre-disease performance without restriction 1. = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours 3. = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 4. = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 5. = Dead
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Eastern Cooperative Group (ECOG) Performance Status
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 2
- upper Limit
- 8
- value
- 3
- group Id
- BG001
- lower Limit
- 4
- upper Limit
- 14
- value
- 6.5
- group Id
- BG002
- lower Limit
- 4
- upper Limit
- 7
- value
- 4
- group Id
- BG003
- lower Limit
- 4
- upper Limit
- 10
- value
- 5
- group Id
- BG004
- lower Limit
- 4
- upper Limit
- 11
- value
- 4
- group Id
- BG005
- lower Limit
- 2
- upper Limit
- 14
- value
- 5
- title
- All Prior Cancer Treatment Regimens
- categories
- measurements
- group Id
- BG000
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG001
- lower Limit
- 1
- upper Limit
- 3
- value
- 1
- group Id
- BG002
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG003
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG004
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- BG005
- lower Limit
- 1
- upper Limit
- 3
- value
- 1
- title
- Prior FLT3 Inhibitor Treatment Regimens
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Prior Cancer Therapies
- unit Of Measure
- Number of treatment regimens
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Preserved source evidence · Not medical advice
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