TriangleNCT01761266 · OUTCOME
Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- nanogram*hour per milliliter (ng*h/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1, Cycle 2 Day 1: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days)
What was measured
AUC was assessed on Cycle 1 Day 1, Cycle 2 Day 1 and Cycle 1 Day 15. Summarized data for all time points was reported. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
Analysis population: The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of lenvatinib and had at least 1 quantifiable lenvatinib concentration.
Groups in this outcome
Lenvatinib 8 mg
Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
Lenvatinib 12 mg
Participants received lenvatinib 12 mg capsules based on the participant's body weight (\>=60 kg) at Baseline, orally, once daily in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
| Group | Source count |
|---|---|
| Lenvatinib 8 mg | 150 |
| Lenvatinib 12 mg | 318 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenvatinib 8 mg | 1969.6 | 743.0 | Not reported | Not reported | Not reported |
| Lenvatinib 12 mg | 2120.9 | 685.6 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 743.0
- value
- 1969.6
- group Id
- OG001
- spread
- 685.6
- value
- 2120.9
- denoms
- counts
- group Id
- OG000
- value
- 150
- group Id
- OG001
- value
- 318
- units
- Participants
- description
- AUC was assessed on Cycle 1 Day 1, Cycle 2 Day 1 and Cycle 1 Day 15. Summarized data for all time points was reported. As planned, data for this secondary endpoint was collected and analyzed up to the primary completion date.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received lenvatinib capsules 12 mg based on the participant's body weight \>=60 kg or 8 mg based on the participant's body weight \<60 kg at baseline, orally, once daily (QD) in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG000
- title
- Lenvatinib 8 mg
- description
- Participants received lenvatinib 12 mg capsules based on the participant's body weight (\>=60 kg) at Baseline, orally, once daily in continuous 28-day treatment cycles up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
- id
- OG001
- title
- Lenvatinib 12 mg
- param Type
- MEAN
- population Description
- The pharmacokinetic (PK) analysis set included all participants who had received at least 1 dose of lenvatinib and had at least 1 quantifiable lenvatinib concentration.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1, Cycle 2 Day 1: pre-dose, 0.5-4 and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 2-12 hours post-dose (cycle length= 28 days)
- title
- Area Under the Plasma Drug Concentration-time Curve (AUC) for Lenvatinib
- type
- SECONDARY
- unit Of Measure
- nanogram*hour per milliliter (ng*h/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice