TriangleNCT01761240 · OUTCOME
Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- 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, "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 | 6 |
| MORAb-066 3 mg/kg | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MORAb-066 0.1 mg/kg | 1.28 | Not reported | 1.27 | 3.07 | Not reported |
| MORAb-066 0.3 mg/kg | 1.30 | Not reported | 1.25 | 3.00 | Not reported |
| MORAb-066 1 mg/kg | 1.25 | Not reported | 1.02 | 3.00 | Not reported |
| MORAb-066 2 mg/kg | 1.80 | Not reported | 1.70 | 3.07 | Not reported |
| MORAb-066 3 mg/kg | 1.82 | Not reported | 1.75 | 3.93 | 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 | 1.33 | Not reported | 1.25 | 2.00 | Not reported |
| MORAb-066 0.3 mg/kg | 1.25 | Not reported | 1.25 | 1.25 | Not reported |
| MORAb-066 1 mg/kg | 1.25 | Not reported | 1.22 | 43.27 | Not reported |
| MORAb-066 2 mg/kg | 1.92 | Not reported | 1.37 | 3.52 | Not reported |
| MORAb-066 3 mg/kg | 1.77 | Not reported | 1.75 | 1.78 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.27
- upper Limit
- 3.07
- value
- 1.28
- group Id
- OG001
- lower Limit
- 1.25
- upper Limit
- 3.00
- value
- 1.30
- group Id
- OG002
- lower Limit
- 1.02
- upper Limit
- 3.00
- value
- 1.25
- group Id
- OG003
- lower Limit
- 1.70
- upper Limit
- 3.07
- value
- 1.80
- group Id
- OG004
- lower Limit
- 1.75
- upper Limit
- 3.93
- value
- 1.82
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 8
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.25
- upper Limit
- 2.00
- value
- 1.33
- group Id
- OG001
- lower Limit
- 1.25
- upper Limit
- 1.25
- value
- 1.25
- group Id
- OG002
- lower Limit
- 1.22
- upper Limit
- 43.27
- value
- 1.25
- group Id
- OG003
- lower Limit
- 1.37
- upper Limit
- 3.52
- value
- 1.92
- group Id
- OG004
- lower Limit
- 1.75
- upper Limit
- 1.78
- value
- 1.77
- 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
- Full Range
- 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
- MEDIAN
- population Description
- The 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
- Tmax: Time to Reach Maximum Serum Concentration for MORAb-066
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice