TriangleNCT01761240 · OUTCOME
CL: Total Body Clearance for MORAb-066
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- liter per hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Analysis population: The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.
Groups in this outcome
MORAb-066 0.1 mg/kg
Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 0.3 mg/kg
Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 1 mg/kg
Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 2 mg/kg
Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
MORAb-066 3 mg/kg
Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 0 |
| MORAb-066 0.3 mg/kg | 2 |
| MORAb-066 1 mg/kg | 4 |
| MORAb-066 2 mg/kg | 1 |
| MORAb-066 3 mg/kg | 1 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 0 |
| MORAb-066 0.3 mg/kg | 2 |
| MORAb-066 1 mg/kg | 4 |
| MORAb-066 2 mg/kg | 1 |
| MORAb-066 3 mg/kg | 1 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.3 mg/kg | 0.1048 | 0.05268 | Not reported | Not reported | Not reported |
| MORAb-066 1 mg/kg | 0.0516 | 0.00894 | Not reported | Not reported | Not reported |
| MORAb-066 2 mg/kg | 0.0362 | NA | Not reported | Not reported | Standard deviation could not be calculated as only one participant was analyzed. |
| MORAb-066 3 mg/kg | 0.0488 | NA | Not reported | Not reported | Standard deviation could not be calculated as only one participant was analyzed. |
Cycle 1 Day 22
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 0 |
| MORAb-066 0.3 mg/kg | 1 |
| MORAb-066 1 mg/kg | 1 |
| MORAb-066 2 mg/kg | 0 |
| MORAb-066 3 mg/kg | 0 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.3 mg/kg | 0.1060 | NA | Not reported | Not reported | Standard deviation could not be calculated as only one participant was analyzed. |
| MORAb-066 1 mg/kg | 0.0396 | NA | Not reported | Not reported | Standard deviation could not be calculated as only one participant was analyzed. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG001
- spread
- 0.05268
- value
- 0.1048
- group Id
- OG002
- spread
- 0.00894
- value
- 0.0516
- comment
- Standard deviation could not be calculated as only one participant was analyzed.
- group Id
- OG003
- spread
- NA
- value
- 0.0362
- comment
- Standard deviation could not be calculated as only one participant was analyzed.
- group Id
- OG004
- spread
- NA
- value
- 0.0488
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- Standard deviation could not be calculated as only one participant was analyzed.
- group Id
- OG001
- spread
- NA
- value
- 0.1060
- comment
- Standard deviation could not be calculated as only one participant was analyzed.
- group Id
- OG002
- spread
- NA
- value
- 0.0396
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Cycle 1 Day 22
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received MORAb-066 0.1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG000
- title
- MORAb-066 0.1 mg/kg
- description
- Participants received MORAb-066 0.3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG001
- title
- MORAb-066 0.3 mg/kg
- description
- Participants received MORAb-066 1 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG002
- title
- MORAb-066 1 mg/kg
- description
- Participants received MORAb-066 2 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant's discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG003
- title
- MORAb-066 2 mg/kg
- description
- Participants received MORAb-066 3 mg/kg, infusion intravenously, on Days 1, 8, 15, and 22, in each 28-day treatment cycle until disease progression, the participant discontinuation due to unacceptable toxicity, withdrawal by participants, or discontinuation by study physician decision.
- id
- OG004
- title
- MORAb-066 3 mg/kg
- param Type
- MEAN
- population Description
- The PK analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. Here, "Number analyzed" signifies participants evaluable at a given time points for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
- title
- CL: Total Body Clearance for MORAb-066
- type
- SECONDARY
- unit Of Measure
- liter per hour
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Preserved source evidence · Not medical advice