NCT03125902 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- FG000
- title
- Placebo + Paclitaxel
- description
- Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- FG001
- title
- Atezolizumab + Paclitaxel
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 119
- group Id
- FG001
- num Subjects
- 229
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 13
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- Other
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 3
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 74
- group Id
- FG001
- num Subjects
- 143
- type
- Study Terminated By Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 21
- group Id
- FG001
- num Subjects
- 37
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 220
- group Id
- FG001
- num Subjects
- 431
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 220
- group Id
- FG001
- num Subjects
- 431
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.
Complete source fields
- groups
- description
- Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- FG000
- title
- Placebo + Paclitaxel
- description
- Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
- id
- FG001
- title
- Atezolizumab + Paclitaxel
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 1
- type
- Adverse Event
- reasons
- group Id
- FG000
- num Subjects
- 119
- group Id
- FG001
- num Subjects
- 229
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 13
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 4
- type
- Other
- reasons
- group Id
- FG000
- num Subjects
- 2
- group Id
- FG001
- num Subjects
- 1
- type
- Physician Decision
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 3
- type
- Progressive Disease
- reasons
- group Id
- FG000
- num Subjects
- 74
- group Id
- FG001
- num Subjects
- 143
- type
- Study Terminated By Sponsor
- reasons
- group Id
- FG000
- num Subjects
- 21
- group Id
- FG001
- num Subjects
- 37
- type
- Withdrawal by Subject
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 220
- group Id
- FG001
- num Subjects
- 431
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 220
- group Id
- FG001
- num Subjects
- 431
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.
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Preserved source evidence · Not medical advice
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