NCT02009449 · OUTCOME
Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 29
What was measured
Serum concentration of Pegilodecakin is reported.
Analysis population: Participants who received at least one dose of the study intervention and had evaluable PK data. Per protocol, PK data was pre-specified to be analyzed by Pegilodecakin dose levels across all parts.
Groups in this outcome
Pegilodecakin 0.08/0.1 mg
Participants who received 0.08 or 0.1 mg of Pegilodecakin once QD administered SC across all parts are grouped under this arm.
Pegilodecakin 0.2/0.25 mg
Participants who received 0.2 or 0.25 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
Pegilodecakin 0.4/0.5 mg
Participants who received 0.4 or 0.5 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
Pegilodecakin 0.8/1 mg
Participants who received 0.8 or 1 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
Pegilodecakin 1.6/2 mg
Participants who received 1.6 or 2 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
Pegilodecakin 3.2/4 mg
Participants who received 3.2 or 4 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
| Group | Source count |
|---|---|
| Pegilodecakin 0.08/0.1 mg | 4 |
| Pegilodecakin 0.2/0.25 mg | 11 |
| Pegilodecakin 0.4/0.5 mg | 11 |
| Pegilodecakin 0.8/1 mg | 9 |
| Pegilodecakin 1.6/2 mg | 31 |
| Pegilodecakin 3.2/4 mg | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pegilodecakin 0.08/0.1 mg | 1.36 | 172 | Not reported | Not reported | Not reported |
| Pegilodecakin 0.2/0.25 mg | 1.33 | 59 | Not reported | Not reported | Not reported |
| Pegilodecakin 0.4/0.5 mg | 3.33 | 61 | Not reported | Not reported | Not reported |
| Pegilodecakin 0.8/1 mg | 7.32 | 93 | Not reported | Not reported | Not reported |
| Pegilodecakin 1.6/2 mg | 25.4 | 75 | Not reported | Not reported | Not reported |
| Pegilodecakin 3.2/4 mg | 33.2 | 26 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 172
- value
- 1.36
- group Id
- OG001
- spread
- 59
- value
- 1.33
- group Id
- OG002
- spread
- 61
- value
- 3.33
- group Id
- OG003
- spread
- 93
- value
- 7.32
- group Id
- OG004
- spread
- 75
- value
- 25.4
- group Id
- OG005
- spread
- 26
- value
- 33.2
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 11
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 31
- group Id
- OG005
- value
- 2
- units
- Participants
- description
- Serum concentration of Pegilodecakin is reported.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants who received 0.08 or 0.1 mg of Pegilodecakin once QD administered SC across all parts are grouped under this arm.
- id
- OG000
- title
- Pegilodecakin 0.08/0.1 mg
- description
- Participants who received 0.2 or 0.25 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
- id
- OG001
- title
- Pegilodecakin 0.2/0.25 mg
- description
- Participants who received 0.4 or 0.5 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
- id
- OG002
- title
- Pegilodecakin 0.4/0.5 mg
- description
- Participants who received 0.8 or 1 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
- id
- OG003
- title
- Pegilodecakin 0.8/1 mg
- description
- Participants who received 1.6 or 2 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
- id
- OG004
- title
- Pegilodecakin 1.6/2 mg
- description
- Participants who received 3.2 or 4 mg of Pegilodecakin QD administered SC across all parts are grouped under this arm.
- id
- OG005
- title
- Pegilodecakin 3.2/4 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- Participants who received at least one dose of the study intervention and had evaluable PK data. Per protocol, PK data was pre-specified to be analyzed by Pegilodecakin dose levels across all parts.
- reporting Status
- POSTED
- time Frame
- Day 29
- title
- Pharmacokinetic (PK): Serum Concentration of Pegilodecakin
- type
- PRIMARY
- unit Of Measure
- nanogram per milliliter (ng/mL)
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Preserved source evidence · Not medical advice
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