NCT01001442 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG000
- title
- BT062 40 mg/m²
- description
- 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG001
- title
- BT062 50 mg/m²
- description
- 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG002
- title
- BT062 65 mg/m²
- description
- 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG003
- title
- BT062 80 mg/m²
- description
- 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG004
- title
- BT062 100 mg/m²
- description
- 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG005
- title
- BT062 120 mg/m²
- description
- 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG006
- title
- BT062 140 mg/m²
- description
- 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG007
- title
- BT062 160 mg/m²
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 4
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 6
- group Id
- FG007
- num Subjects
- 2
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
Complete source fields
- groups
- description
- 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG000
- title
- BT062 40 mg/m²
- description
- 50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG001
- title
- BT062 50 mg/m²
- description
- 65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG002
- title
- BT062 65 mg/m²
- description
- 80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG003
- title
- BT062 80 mg/m²
- description
- 100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG004
- title
- BT062 100 mg/m²
- description
- 120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG005
- title
- BT062 120 mg/m²
- description
- 140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG006
- title
- BT062 140 mg/m²
- description
- 160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- FG007
- title
- BT062 160 mg/m²
- periods
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 4
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 4
- group Id
- FG003
- num Subjects
- 3
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 6
- group Id
- FG007
- num Subjects
- 2
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 2
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 2
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- The Intention-to-treat (ITT) population included all subjects who were enrolled in the study and received at least 1 dose of BT062 and who had any post-Baseline evaluations or data. One subject did not have at least one post-injection assessment of the treatment response and was excluded from both the ITT and PP populations (n = 34).
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Preserved source evidence · Not medical advice
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