NCT04334759 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- FG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
- id
- FG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- FG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
- id
- FG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 6
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 87
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 11
- group Id
- FG003
- num Subjects
- 13
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Not Treated
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Patient moved to off label supply of durvalumab following declaration of study closure by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Functional decline due to medical comorbidities
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Required use of prohibited concomitant treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- The patient is not dead.
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- type
- Patient continuing with nivolumab treatment beyond declaration of study closure by sponsor
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 114
- group Id
- FG001
- num Subjects
- 60
- group Id
- FG002
- num Subjects
- 17
- group Id
- FG003
- num Subjects
- 23
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 38
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 114
- group Id
- FG001
- num Subjects
- 22
- group Id
- FG002
- num Subjects
- 17
- group Id
- FG003
- num Subjects
- 23
- type
- NOT COMPLETED
- title
- Overall Study
Complete source fields
- groups
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- FG000
- title
- Experimental Arm for Chemo Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Standard Chemotherapy for 4 to 6 cycles, followed by Observation
- id
- FG001
- title
- Control Arm for Chemo Cohort: Chemotherapy, Then Observation
- description
- Durvalumab + Standard Chemotherapy for 4 to 6 cycles, followed by Maintenance with Durvalumab
- id
- FG002
- title
- Experimental Arm for IO Cohort: Durvalumab + Chemotherapy, Then Durvalumab Maintenance
- description
- Ipilimumab every 6 weeks and Nivolumab every 2 or 3 weeks for up to 2 years.
- id
- FG003
- title
- Control Arm for IO Cohort: Ipilimumab and Nivolumab
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 6
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 6
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 2
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 1
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 87
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 11
- group Id
- FG003
- num Subjects
- 13
- type
- Disease Progression
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 5
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Not Treated
- reasons
- group Id
- FG000
- num Subjects
- 5
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- Patient moved to off label supply of durvalumab following declaration of study closure by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Functional decline due to medical comorbidities
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- Required use of prohibited concomitant treatment
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 0
- type
- The patient is not dead.
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 2
- type
- Patient continuing with nivolumab treatment beyond declaration of study closure by sponsor
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 114
- group Id
- FG001
- num Subjects
- 60
- group Id
- FG002
- num Subjects
- 17
- group Id
- FG003
- num Subjects
- 23
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 38
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 114
- group Id
- FG001
- num Subjects
- 22
- group Id
- FG002
- num Subjects
- 17
- group Id
- FG003
- num Subjects
- 23
- type
- NOT COMPLETED
- title
- Overall Study
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
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