NCT05169567 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- FG000
- title
- Arm A: Abemaciclib Plus Fulvestrant
- description
- Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- FG001
- title
- Arm B: Placebo Plus Fulvestrant
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 116
- group Id
- FG001
- num Subjects
- 128
- type
- On study treatment
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 25
- group Id
- FG001
- num Subjects
- 21
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 182
- group Id
- FG001
- num Subjects
- 186
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 181
- group Id
- FG001
- num Subjects
- 185
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 37
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 142
- group Id
- FG001
- num Subjects
- 149
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Completers included participants who had an event (progressive disease or death) and participants who were off the treatment and were alive at study conclusion.
Complete source fields
- groups
- description
- Abemaciclib 150 milligram (mg) administered orally twice daily (BID) on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- FG000
- title
- Arm A: Abemaciclib Plus Fulvestrant
- description
- Placebo administered orally BID on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500 mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation criteria were met.
- id
- FG001
- title
- Arm B: Placebo Plus Fulvestrant
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 116
- group Id
- FG001
- num Subjects
- 128
- type
- On study treatment
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 25
- group Id
- FG001
- num Subjects
- 21
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 182
- group Id
- FG001
- num Subjects
- 186
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 181
- group Id
- FG001
- num Subjects
- 185
- type
- Received at Least One Dose of Study Drug
- achievements
- group Id
- FG000
- num Subjects
- 40
- group Id
- FG001
- num Subjects
- 37
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 142
- group Id
- FG001
- num Subjects
- 149
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Completers included participants who had an event (progressive disease or death) and participants who were off the treatment and were alive at study conclusion.
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