NCT01772004 · 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
- 4
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 184
- group Id
- BG006
- value
- 156
- group Id
- BG007
- value
- 168
- group Id
- BG008
- value
- 60
- group Id
- BG009
- value
- 90
- group Id
- BG010
- value
- 21
- group Id
- BG011
- value
- 18
- units
- Participants
- groups
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG000
- title
- Dose Escalation Cohort: Avelumab 1.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
- id
- BG001
- title
- Dose Escalation Cohort: Avelumab 3.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG002
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG003
- title
- Dose Escalation Cohort: Avelumab 20.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG004
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
- description
- Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG005
- title
- Primary Expansion Cohort: NSCLC, Post-platinum Doublet
- description
- Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG006
- title
- Primary Expansion Cohort: NSCLC, First Line
- description
- Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG007
- title
- Primary Expansion Cohort: Metastatic Breast Cancer
- description
- Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG008
- title
- Primary Expansion Cohort: GC/GEJC Progressed
- description
- Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG009
- title
- Primary Expansion Cohort: GC/GEJC Non Progressed
- description
- Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG010
- title
- Secondary Expansion Cohort: Colorectal Cancer
- description
- Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG011
- title
- Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
- 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
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 90
- group Id
- BG006
- value
- 51
- group Id
- BG007
- value
- 140
- group Id
- BG008
- value
- 38
- group Id
- BG009
- value
- 61
- group Id
- BG010
- value
- 19
- group Id
- BG011
- value
- 7
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 94
- group Id
- BG006
- value
- 105
- group Id
- BG007
- value
- 28
- group Id
- BG008
- value
- 22
- group Id
- BG009
- value
- 29
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 11
- 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
- 9
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 84
- group Id
- BG006
- value
- 73
- group Id
- BG007
- value
- 167
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 22
- group Id
- BG010
- value
- 7
- group Id
- BG011
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 14
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 100
- group Id
- BG006
- value
- 83
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 46
- group Id
- BG009
- value
- 68
- group Id
- BG010
- value
- 14
- group Id
- BG011
- value
- 18
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- calculate Pct
- false
- 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
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 5
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 13
- group Id
- BG009
- value
- 35
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- 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
- 2
- 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
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 12
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 16
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 20
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 159
- group Id
- BG006
- value
- 124
- group Id
- BG007
- value
- 141
- group Id
- BG008
- value
- 36
- group Id
- BG009
- value
- 44
- group Id
- BG010
- value
- 17
- group Id
- BG011
- value
- 12
- 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
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 14
- group Id
- BG007
- value
- 8
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 7
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 4
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 15
- group Id
- BG003
- value
- 21
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 184
- group Id
- BG006
- value
- 156
- group Id
- BG007
- value
- 168
- group Id
- BG008
- value
- 60
- group Id
- BG009
- value
- 90
- group Id
- BG010
- value
- 21
- group Id
- BG011
- value
- 18
- units
- Participants
- groups
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 1.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG000
- title
- Dose Escalation Cohort: Avelumab 1.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 3.0 milligrams per kilogram (mg/kg) once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or investigational medicinal product (IMP) occurs.
- id
- BG001
- title
- Dose Escalation Cohort: Avelumab 3.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG002
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 20.0 mg/kg once every 2 weeks in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG003
- title
- Dose Escalation Cohort: Avelumab 20.0 mg/kg
- description
- Participants with metastatic or locally advanced solid tumors received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once weekly for the first 12 weeks and once every 2 weeks starting Week 13 in dose escalation cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG004
- title
- Dose Escalation Cohort: Avelumab 10.0 mg/kg Weekly
- description
- Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG005
- title
- Primary Expansion Cohort: NSCLC, Post-platinum Doublet
- description
- Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG006
- title
- Primary Expansion Cohort: NSCLC, First Line
- description
- Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG007
- title
- Primary Expansion Cohort: Metastatic Breast Cancer
- description
- Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG008
- title
- Primary Expansion Cohort: GC/GEJC Progressed
- description
- Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG009
- title
- Primary Expansion Cohort: GC/GEJC Non Progressed
- description
- Participants with colorectal cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG010
- title
- Secondary Expansion Cohort: Colorectal Cancer
- description
- Participants with castrate-resistant prostate cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
- id
- BG011
- title
- Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
- 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
- 3
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 10
- group Id
- BG003
- value
- 18
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 90
- group Id
- BG006
- value
- 51
- group Id
- BG007
- value
- 140
- group Id
- BG008
- value
- 38
- group Id
- BG009
- value
- 61
- group Id
- BG010
- value
- 19
- group Id
- BG011
- value
- 7
- title
- Between 18 and 65 years
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 5
- group Id
- BG003
- value
- 3
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 94
- group Id
- BG006
- value
- 105
- group Id
- BG007
- value
- 28
- group Id
- BG008
- value
- 22
- group Id
- BG009
- value
- 29
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 11
- 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
- 9
- group Id
- BG002
- value
- 8
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 84
- group Id
- BG006
- value
- 73
- group Id
- BG007
- value
- 167
- group Id
- BG008
- value
- 14
- group Id
- BG009
- value
- 22
- group Id
- BG010
- value
- 7
- group Id
- BG011
- value
- 0
- title
- Female
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 7
- group Id
- BG003
- value
- 14
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 100
- group Id
- BG006
- value
- 83
- group Id
- BG007
- value
- 1
- group Id
- BG008
- value
- 46
- group Id
- BG009
- value
- 68
- group Id
- BG010
- value
- 14
- group Id
- BG011
- value
- 18
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- calculate Pct
- false
- 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
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 5
- group Id
- BG006
- value
- 6
- group Id
- BG007
- value
- 3
- group Id
- BG008
- value
- 13
- group Id
- BG009
- value
- 35
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 0
- 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
- 2
- 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
- 0
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 12
- group Id
- BG006
- value
- 12
- group Id
- BG007
- value
- 16
- group Id
- BG008
- value
- 4
- group Id
- BG009
- value
- 4
- group Id
- BG010
- value
- 2
- group Id
- BG011
- value
- 4
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 13
- group Id
- BG002
- value
- 11
- group Id
- BG003
- value
- 20
- group Id
- BG004
- value
- 5
- group Id
- BG005
- value
- 159
- group Id
- BG006
- value
- 124
- group Id
- BG007
- value
- 141
- group Id
- BG008
- value
- 36
- group Id
- BG009
- value
- 44
- group Id
- BG010
- value
- 17
- group Id
- BG011
- value
- 12
- 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
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 6
- group Id
- BG006
- value
- 14
- group Id
- BG007
- value
- 8
- group Id
- BG008
- value
- 7
- group Id
- BG009
- value
- 7
- group Id
- BG010
- value
- 1
- group Id
- BG011
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle