TriangleNCT01849874 · OUTCOME
Predose Plasma Concentration (Ctrough) of MEK162
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 (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose on Study Days 1, 57, and 113.
What was measured
Ctrough of MEK162 is defined as the predose plasma concentration of MEK162. Ctrough of MEK162 was observed directly from data.
Analysis population: The pharmacokinetics (PK) set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.
Groups in this outcome
MEK162
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
| Group | Source count |
|---|---|
| MEK162 | 65 |
Reported measurements
Week 1 (Study Day 1)
| Group | Source count |
|---|---|
| MEK162 | 65 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 42.2 | NA | Not reported | Not reported | The geometric coefficient of variation was statistically non-estimable for this dataset at Week 1 (Study Day 1). |
Week 9 (Study Day 57)
| Group | Source count |
|---|---|
| MEK162 | 38 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 69.3 | 1.54 | Not reported | Not reported | Not reported |
Week 17 (Study Day 113)
| Group | Source count |
|---|---|
| MEK162 | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MEK162 | 56.5 | 1.68 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- The geometric coefficient of variation was statistically non-estimable for this dataset at Week 1 (Study Day 1).
- group Id
- OG000
- spread
- NA
- value
- 42.2
- denoms
- counts
- group Id
- OG000
- value
- 65
- units
- Participants
- title
- Week 1 (Study Day 1)
- categories
- measurements
- group Id
- OG000
- spread
- 1.54
- value
- 69.3
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- title
- Week 9 (Study Day 57)
- categories
- measurements
- group Id
- OG000
- spread
- 1.68
- value
- 56.5
- denoms
- counts
- group Id
- OG000
- value
- 33
- units
- Participants
- title
- Week 17 (Study Day 113)
- denoms
- counts
- group Id
- OG000
- value
- 65
- units
- Participants
- description
- Ctrough of MEK162 is defined as the predose plasma concentration of MEK162. Ctrough of MEK162 was observed directly from data.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
- id
- OG000
- title
- MEK162
- param Type
- GEOMETRIC_MEAN
- population Description
- The pharmacokinetics (PK) set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.
- reporting Status
- POSTED
- time Frame
- Predose on Study Days 1, 57, and 113.
- title
- Predose Plasma Concentration (Ctrough) of MEK162
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice