NCT02142803 · 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
- 3
- group Id
- BG002
- value
- 43
- group Id
- BG003
- value
- 49
- units
- Participants
- groups
- description
- 3 mg/day MLN0128
- id
- BG000
- title
- Dose Level 1
- description
- 4 mg/day MLN0128
- id
- BG001
- title
- Dose Level 2
- description
- 5 mg/day MLN0128
- id
- BG002
- title
- Dose Level 3 (MTD)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 55
- upper Limit
- 65
- value
- 56
- group Id
- BG001
- lower Limit
- 30
- upper Limit
- 62
- value
- 42
- group Id
- BG002
- lower Limit
- 36
- upper Limit
- 84
- value
- 59
- group Id
- BG003
- lower Limit
- 30
- upper Limit
- 84
- value
- 59
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 35
- group Id
- BG003
- value
- 38
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 11
- 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
- 1
- group Id
- BG003
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 41
- group Id
- BG003
- value
- 47
- 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
- 1
- title
- Unknown or Not Reported
- description
- National Institutes of Health (NIH) / Office of Management and Budget (OMB) Standards
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 39
- group Id
- BG003
- value
- 44
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- title
- Unknown or Not Reported
- description
- National Institutes of Health (NIH) / Office of Management and Budget (OMB) Standards
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- BG001
- lower Limit
- 0
- upper Limit
- 1
- value
- 0
- group Id
- BG002
- lower Limit
- 0
- upper Limit
- 1
- value
- 1
- group Id
- BG003
- lower Limit
- 0
- upper Limit
- 1
- value
- 1
- description
- ECOG 0 = Normal activity. Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). NOTE: Performance Status (PS) for patients with endometrial and ovarian cancer is reported via ECOG scale (0-5); PS for patients with glioblastoma is reported via Karnofsky (KPS) scale (100-0). Baseline PS for GBM patients has been converted from KPS to ECOG scale for reporting consistency.
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
- unit Of Measure
- units on a scale
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 43
- group Id
- BG003
- value
- 49
- units
- Participants
- groups
- description
- 3 mg/day MLN0128
- id
- BG000
- title
- Dose Level 1
- description
- 4 mg/day MLN0128
- id
- BG001
- title
- Dose Level 2
- description
- 5 mg/day MLN0128
- id
- BG002
- title
- Dose Level 3 (MTD)
- description
- Total of all reporting groups
- id
- BG003
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 55
- upper Limit
- 65
- value
- 56
- group Id
- BG001
- lower Limit
- 30
- upper Limit
- 62
- value
- 42
- group Id
- BG002
- lower Limit
- 36
- upper Limit
- 84
- value
- 59
- group Id
- BG003
- lower Limit
- 30
- upper Limit
- 84
- value
- 59
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 35
- group Id
- BG003
- value
- 38
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 11
- 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
- 1
- group Id
- BG003
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 41
- group Id
- BG003
- value
- 47
- 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
- 1
- title
- Unknown or Not Reported
- description
- National Institutes of Health (NIH) / Office of Management and Budget (OMB) Standards
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 1
- group Id
- BG003
- 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
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 1
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 39
- group Id
- BG003
- value
- 44
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 2
- title
- Unknown or Not Reported
- description
- National Institutes of Health (NIH) / Office of Management and Budget (OMB) Standards
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- BG001
- lower Limit
- 0
- upper Limit
- 1
- value
- 0
- group Id
- BG002
- lower Limit
- 0
- upper Limit
- 1
- value
- 1
- group Id
- BG003
- lower Limit
- 0
- upper Limit
- 1
- value
- 1
- description
- ECOG 0 = Normal activity. Fully active, able to carry on all pre-disease performance without restriction. ECOG 1 = Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). NOTE: Performance Status (PS) for patients with endometrial and ovarian cancer is reported via ECOG scale (0-5); PS for patients with glioblastoma is reported via Karnofsky (KPS) scale (100-0). Baseline PS for GBM patients has been converted from KPS to ECOG scale for reporting consistency.
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice
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