TriangleNCT02064387 · OUTCOME
Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM-Part 2
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Nanograms per milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
What was measured
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Analysis population: PK Part 2 MM Population comprised of Part 2 MM participants of All Treated Population who had atleast 1 non-missing (NQ) PK assessment. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Groups in this outcome
Part 2: GSK2857916 3.40 mg/kg (MM)
Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 35 |
Reported measurements
Day 1, Cycle 1,n=28
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 28 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 3486.49 | 85.71 | Not reported | Not reported | Not reported |
Day 1, Cycle 2,n=18
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 18 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 5799.89 | 66.52 | Not reported | Not reported | Not reported |
Day 1, Cycle 4,n=12
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (MM) | 6184.46 | 103.79 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 85.71
- value
- 3486.49
- denoms
- counts
- group Id
- OG000
- value
- 28
- units
- Participants
- title
- Day 1, Cycle 1,n=28
- categories
- measurements
- group Id
- OG000
- spread
- 66.52
- value
- 5799.89
- denoms
- counts
- group Id
- OG000
- value
- 18
- units
- Participants
- title
- Day 1, Cycle 2,n=18
- categories
- measurements
- group Id
- OG000
- spread
- 103.79
- value
- 6184.46
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- title
- Day 1, Cycle 4,n=12
- denoms
- counts
- group Id
- OG000
- value
- 35
- units
- Participants
- description
- Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with multiple myeloma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle=21 days).
- id
- OG000
- title
- Part 2: GSK2857916 3.40 mg/kg (MM)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Part 2 MM Population comprised of Part 2 MM participants of All Treated Population who had atleast 1 non-missing (NQ) PK assessment. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
- reporting Status
- POSTED
- time Frame
- Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
- title
- Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM-Part 2
- type
- SECONDARY
- unit Of Measure
- Nanograms per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice