NCT03239145 · 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
- 40
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 58
- units
- Participants
- groups
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
- id
- BG000
- title
- [Dose Level I] Pembrolizumab + Trebananib
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG001
- title
- [Dose Level II] Pembrolizumab + Trebananib (Colorectal)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG002
- title
- [Dose Level II] Pembrolizumab + Trebananib (Ovarian)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG003
- title
- [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 32.3
- upper Limit
- 57.0
- value
- 40.8
- group Id
- BG001
- lower Limit
- 29.7
- upper Limit
- 74.3
- value
- 53.8
- group Id
- BG002
- lower Limit
- 51.9
- upper Limit
- 74.6
- value
- 63.6
- group Id
- BG003
- lower Limit
- 51.7
- upper Limit
- 62.5
- value
- 56.3
- group Id
- BG004
- lower Limit
- 29.7
- upper Limit
- 74.6
- value
- 55.4
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 32
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 23
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 26
- 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
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 32
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 50
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 7
- 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
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 6
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- title
- Black or African American
- categories
- 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
- 1
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 32
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 48
- title
- White
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 34
- title
- Performance Status 0
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 24
- title
- Performance Status 1
- description
- The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess a patient's level of functioning and ability to perform daily activities, and to evaluate how a disease affects a patient's quality of life. It is widely used in oncology clinical trials to determine eligibility, stratify patients, and assess prognosis. 0 - Fully active; able to carry on all pre-disease activities without restriction. 1 - Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work (e.g., light housework, office work).
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status
- unit Of Measure
- Participants
- population Description
- Per protocol, patient characteristics will be summarized by cohort; the dose escalation and dose expansion data could be combined for patients with the same cancer type and the same treatment doses. Baseline characteristics are summarized for treated participants.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 40
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 58
- units
- Participants
- groups
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 15 mg/kg weekly.
- id
- BG000
- title
- [Dose Level I] Pembrolizumab + Trebananib
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG001
- title
- [Dose Level II] Pembrolizumab + Trebananib (Colorectal)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG002
- title
- [Dose Level II] Pembrolizumab + Trebananib (Ovarian)
- description
- Participants received pembrolizumab 200 mg administered intravenously every 3 weeks in combination with trebananib administered intravenously at 30 mg/kg weekly.
- id
- BG003
- title
- [Dose Level II] Pembrolizumab + Trebananib (Renal Cell Carcinoma)
- description
- Total of all reporting groups
- id
- BG004
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- lower Limit
- 32.3
- upper Limit
- 57.0
- value
- 40.8
- group Id
- BG001
- lower Limit
- 29.7
- upper Limit
- 74.3
- value
- 53.8
- group Id
- BG002
- lower Limit
- 51.9
- upper Limit
- 74.6
- value
- 63.6
- group Id
- BG003
- lower Limit
- 51.7
- upper Limit
- 62.5
- value
- 56.3
- group Id
- BG004
- lower Limit
- 29.7
- upper Limit
- 74.6
- value
- 55.4
- dispersion Type
- FULL_RANGE
- param Type
- MEDIAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 17
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 32
- title
- Female
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 23
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 26
- 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
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 32
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 50
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 7
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 7
- 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
- 4
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 6
- title
- Asian
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- title
- Black or African American
- categories
- 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
- 1
- title
- Other
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 32
- group Id
- BG002
- value
- 9
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 48
- title
- White
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 26
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 34
- title
- Performance Status 0
- categories
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 14
- group Id
- BG002
- value
- 6
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 24
- title
- Performance Status 1
- description
- The Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale used to assess a patient's level of functioning and ability to perform daily activities, and to evaluate how a disease affects a patient's quality of life. It is widely used in oncology clinical trials to determine eligibility, stratify patients, and assess prognosis. 0 - Fully active; able to carry on all pre-disease activities without restriction. 1 - Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work (e.g., light housework, office work).
- param Type
- COUNT_OF_PARTICIPANTS
- title
- ECOG Performance Status
- unit Of Measure
- Participants
- population Description
- Per protocol, patient characteristics will be summarized by cohort; the dose escalation and dose expansion data could be combined for patients with the same cancer type and the same treatment doses. Baseline characteristics are summarized for treated participants.
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