TriangleNCT00652626 · OUTCOME
Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- liters/hour
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
What was measured
The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.
Analysis population: Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
Groups in this outcome
Normal RF: Azacitidine 75 mg/m^2
Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
Severe RI: Azacitidine 75 mg/m^2
Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
| Group | Source count |
|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 6 |
| Severe RI: Azacitidine 75 mg/m^2 | 6 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 151.55 | 30.88 | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 85.76 | 68.83 | Not reported | Not reported | Not reported |
Day 5
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal RF: Azacitidine 75 mg/m^2 | 166.95 | 27.59 | Not reported | Not reported | Not reported |
| Severe RI: Azacitidine 75 mg/m^2 | 111.55 | 51.75 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 30.88
- value
- 151.55
- group Id
- OG001
- spread
- 68.83
- value
- 85.76
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 27.59
- value
- 166.95
- group Id
- OG001
- spread
- 51.75
- value
- 111.55
- title
- Day 5
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- The apparent total clearance of azacitidine after a single dose (Day 1) and multiple doses (Day 5) for participants with normal renal function and severe renal impairment, calculated as Dose/AUC0-inf.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with normal renal function (RF) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG000
- title
- Normal RF: Azacitidine 75 mg/m^2
- description
- Participants with severe renal impairment (RI) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
- id
- OG001
- title
- Severe RI: Azacitidine 75 mg/m^2
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Population, consisting of all participants with evaluable plasma or urine concentration data for azacitidine. This analysis was performed for participants in the 2 treatment groups who received azacitidine treatment for 5 days.
- reporting Status
- POSTED
- time Frame
- Day 1 and Day 5: predose, 5, 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours post-dose
- title
- Apparent Total Clearance of Azacitidine (CL/F) After Single and Multiple Doses of Azacitidine
- type
- PRIMARY
- unit Of Measure
- liters/hour
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Preserved source evidence · Not medical advice