TriangleNCT01001442 · OUTCOME
Qualitative and Quantitative Toxicities of BT062
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)
What was measured
Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs).
Analysis population: Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).
Groups in this outcome
BT062 40 mg/m²
40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 50 mg/m²
50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 65 mg/m²
65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 80 mg/m²
80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 100 mg/m²
100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 120 mg/m²
120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 140 mg/m²
140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
BT062 160 mg/m²
160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
Total
BT062 Administration (all dose levels)
| Group | Source count |
|---|---|
| BT062 40 mg/m² | 4 |
| BT062 50 mg/m² | 3 |
| BT062 65 mg/m² | 4 |
| BT062 80 mg/m² | 3 |
| BT062 100 mg/m² | 4 |
| BT062 120 mg/m² | 3 |
| BT062 140 mg/m² | 10 |
| BT062 160 mg/m² | 4 |
| Total | 35 |
Reported measurements
At least one SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 5 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Total | 14 | Not reported | Not reported | Not reported | Not reported |
At least one treatment related SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| BT062 40 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 50 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 65 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 80 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 100 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 120 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| BT062 140 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| BT062 160 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Total | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 14
- title
- At least one SAE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 3
- title
- At least one treatment related SAE
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 35
- units
- Participants
- description
- Qualitative and quantitative toxicities assessed by incidence of adverse events and by clinically significant changes in the patient's physical examination, vital signs, and clinical laboratory results. The incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs).
- groups
- description
- 40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
- id
- OG000
- 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
- OG001
- 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
- OG002
- 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
- OG003
- 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
- OG004
- 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
- OG005
- 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
- OG006
- 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
- OG007
- title
- BT062 160 mg/m²
- description
- BT062 Administration (all dose levels)
- id
- OG008
- title
- Total
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population: The Safety population included all subjects who were enrolled and received at least 1 dose of BT062 (n = 35).
- reporting Status
- POSTED
- time Frame
- Starting with first study drug administration until 30-day follow-up visit (average 4.99 months)
- title
- Qualitative and Quantitative Toxicities of BT062
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice