TriangleNCT02989857 · OUTCOME
Accumulation Ratio Based on Cmax (Racc Cmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Post-dose Cycle 2 Day 1 (each cycle = 28 days)
What was measured
Crossover C2D1 visit was combined with C2D1 visit for the analysis of this endpoint.
Analysis population: 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 | 100 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase AG-120 Plus Cross Over Phase AG-120 | 1.2369 | 0.50798 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.50798
- value
- 1.2369
- denoms
- counts
- group Id
- OG000
- value
- 100
- units
- Participants
- description
- Crossover C2D1 visit was combined with C2D1 visit 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
- 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 2 Day 1 (each cycle = 28 days)
- title
- Accumulation Ratio Based on Cmax (Racc Cmax)
- type
- SECONDARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice