TriangleNCT01761240 · OUTCOME
Cmax: Maximum Observed Serum Concentration for MORAb-066
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- microgram per milliliter (mcg/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Days 1 and 22: 0-168 hours post-dose (Cycle length=28 days)
Analysis population: The pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. 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 | 3 |
| MORAb-066 0.3 mg/kg | 4 |
| MORAb-066 1 mg/kg | 5 |
| MORAb-066 2 mg/kg | 7 |
| MORAb-066 3 mg/kg | 8 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 3 |
| MORAb-066 0.3 mg/kg | 4 |
| MORAb-066 1 mg/kg | 5 |
| MORAb-066 2 mg/kg | 7 |
| MORAb-066 3 mg/kg | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.1 mg/kg | 2.09 | 0.186 | Not reported | Not reported | Not reported |
| MORAb-066 0.3 mg/kg | 5.26 | 0.826 | Not reported | Not reported | Not reported |
| MORAb-066 1 mg/kg | 23.40 | 5.697 | Not reported | Not reported | Not reported |
| MORAb-066 2 mg/kg | 45.65 | 12.370 | Not reported | Not reported | Not reported |
| MORAb-066 3 mg/kg | 68.61 | 13.201 | Not reported | Not reported | Not reported |
Cycle 1 Day 22
| Group | Source count |
|---|---|
| MORAb-066 0.1 mg/kg | 3 |
| MORAb-066 0.3 mg/kg | 2 |
| MORAb-066 1 mg/kg | 3 |
| MORAb-066 2 mg/kg | 5 |
| MORAb-066 3 mg/kg | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.1 mg/kg | 1.95 | 0.731 | Not reported | Not reported | Not reported |
| MORAb-066 0.3 mg/kg | 4.33 | 0.014 | Not reported | Not reported | Not reported |
| MORAb-066 1 mg/kg | 21.33 | 7.106 | Not reported | Not reported | Not reported |
| MORAb-066 2 mg/kg | 52.68 | 12.544 | Not reported | Not reported | Not reported |
| MORAb-066 3 mg/kg | 121.50 | 30.406 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.186
- value
- 2.09
- group Id
- OG001
- spread
- 0.826
- value
- 5.26
- group Id
- OG002
- spread
- 5.697
- value
- 23.40
- group Id
- OG003
- spread
- 12.370
- value
- 45.65
- group Id
- OG004
- spread
- 13.201
- value
- 68.61
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.731
- value
- 1.95
- group Id
- OG001
- spread
- 0.014
- value
- 4.33
- group Id
- OG002
- spread
- 7.106
- value
- 21.33
- group Id
- OG003
- spread
- 12.544
- value
- 52.68
- group Id
- OG004
- spread
- 30.406
- value
- 121.50
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- Cycle 1 Day 22
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 8
- 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 pharmacokinetic (PK) analysis set was the group of participants who had sufficient PK data to derive at least one PK parameter. 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
- Cmax: Maximum Observed Serum Concentration for MORAb-066
- type
- SECONDARY
- unit Of Measure
- microgram per milliliter (mcg/mL)
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Preserved source evidence · Not medical advice