TriangleNCT01556438 · OUTCOME
Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab
Analysis population: All participants who received at least 1 dose of any study drug and had evaluable PK data. Participants in the 300 mg tabalumab group may have received IV and SC BTZ and may be counted in the IV and SC group for analysis.
Groups in this outcome
100 mg Tabalumab+BTZ IV+Dex
Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
300 mg Tabalumab+ IV BTZ +Dex
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
300 mg Tabalumab+ SC BTZ +Dex
Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab+ IV BTZ +Dex | 4 |
| 300 mg Tabalumab+ SC BTZ +Dex | 8 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 4 |
| 300 mg Tabalumab+ IV BTZ +Dex | 4 |
| 300 mg Tabalumab+ SC BTZ +Dex | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 13300 | 21 | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+ IV BTZ +Dex | 64200 | 35 | Not reported | Not reported | Not reported |
| 300 mg Tabalumab+ SC BTZ +Dex | 50900 | 60 | Not reported | Not reported | Not reported |
Cycle 7 Day 1
| Group | Source count |
|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | 1 |
| 300 mg Tabalumab+ IV BTZ +Dex | 1 |
| 300 mg Tabalumab+ SC BTZ +Dex | 3 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 100 mg Tabalumab+BTZ IV+Dex | NA | NA | Not reported | Not reported | N of 1, no value obtained, no CV value. |
| 300 mg Tabalumab+ IV BTZ +Dex | 84100 | NA | Not reported | Not reported | N of 1, Individual data presented, no CV value. |
| 300 mg Tabalumab+ SC BTZ +Dex | 131000 | NA | Not reported | Not reported | CV not available from N=3 for analysis. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21
- value
- 13300
- group Id
- OG001
- spread
- 35
- value
- 64200
- group Id
- OG002
- spread
- 60
- value
- 50900
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- comment
- N of 1, no value obtained, no CV value.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- N of 1, Individual data presented, no CV value.
- group Id
- OG001
- spread
- NA
- value
- 84100
- comment
- CV not available from N=3 for analysis.
- group Id
- OG002
- spread
- NA
- value
- 131000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- units
- Participants
- title
- Cycle 7 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 8
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
- id
- OG000
- title
- 100 mg Tabalumab+BTZ IV+Dex
- description
- Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ IV.
- id
- OG001
- title
- 300 mg Tabalumab+ IV BTZ +Dex
- description
- Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ SC.
- id
- OG002
- title
- 300 mg Tabalumab+ SC BTZ +Dex
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received at least 1 dose of any study drug and had evaluable PK data. Participants in the 300 mg tabalumab group may have received IV and SC BTZ and may be counted in the IV and SC group for analysis.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Day 1: 6 + or - hours after bortezomib (BTZ); Cycle 7, Day 1: immediately post BTZ dose and 2 hours after tabalumab
- title
- Pharmacokinetics (PK): Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-∞) of Tabalumab (LY2127399)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
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Preserved source evidence · Not medical advice