TriangleNCT02989857 · OUTCOME
Maximum Observed Plasma Concentration (Cmax) of AG-120
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days)
What was measured
Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint.
Analysis population: Pharmacokinetic (PK) Analysis Population consisted of all participants who were enrolled and received at least one dose of study medication (AG-120) with sufficient plasma sample data to assess PK parameters. Number analyzed is the number of participants with data available for analyses at the specified time point.
Groups in this outcome
Randomization Phase AG-120 Plus Cross Over Phase AG-120
Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study. Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle.
| Group | Source count |
|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 142 |
Reported measurements
Cycle 1 Day 1
| Group | Source count |
|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 142 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 4424.0 | 1808.07 | Not reported | Not reported | Not reported |
Cycle 2 Day 1
| Group | Source count |
|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 107 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 5050.5 | 1666.07 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1808.07
- value
- 4424.0
- denoms
- counts
- group Id
- OG000
- value
- 142
- units
- Participants
- title
- Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 1666.07
- value
- 5050.5
- denoms
- counts
- group Id
- OG000
- value
- 107
- units
- Participants
- title
- Cycle 2 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 142
- units
- Participants
- description
- Crossover C1D1 and crossover C2D1 visits were combined with C1D1 and C2D1 visits, respectively for the analysis of this endpoint.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study. Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle.
- id
- OG000
- title
- Randomization Phase AG-120 Plus Cross Over Phase AG-120
- param Type
- MEAN
- population Description
- Pharmacokinetic (PK) Analysis Population consisted of all participants who were enrolled and received at least one dose of study medication (AG-120) with sufficient plasma sample data to assess PK parameters. Number analyzed is the number of participants with data available for analyses at the specified time point.
- reporting Status
- POSTED
- time Frame
- Post-dose Cycle 1 Day 1 and Cycle 2 Day 1 (each cycle = 28 days)
- title
- Maximum Observed Plasma Concentration (Cmax) of AG-120
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice