TriangleNCT02573259 · OUTCOME
AUClast of PF-06801591 in Part 1.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1
What was measured
Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1
Analysis population: Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
Groups in this outcome
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
Part 1: PF-06801591 1 mg/kg (IV)
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
Part 1: PF-06801591 3 mg/kg (IV)
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
Part 1: PF-06801591 10 mg/kg (IV)
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
| Group | Source count |
|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | 2 |
| Part 1: PF-06801591 1 mg/kg (IV) | 7 |
| Part 1: PF-06801591 3 mg/kg (IV) | 7 |
| Part 1: PF-06801591 10 mg/kg (IV) | 7 |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV]) | NA | NA | Not reported | Not reported | Geometric mean and geometric coefficient of variation were not reported for n \< 3. |
| Part 1: PF-06801591 1 mg/kg (IV) | 4700 | 41 | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 3 mg/kg (IV) | 14770 | 27 | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 10 mg/kg (IV) | 46780 | 49 | Not reported | Not reported | Not reported |
| Part 1: PF-06801591 300 mg (Subcutaneously [SC]) | 9923 | 65 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Geometric mean and geometric coefficient of variation were not reported for n \< 3.
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 41
- value
- 4700
- group Id
- OG002
- spread
- 27
- value
- 14770
- group Id
- OG003
- spread
- 49
- value
- 46780
- group Id
- OG004
- spread
- 65
- value
- 9923
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 7
- group Id
- OG004
- value
- 15
- units
- Participants
- description
- Area Under the Concentration Versus Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point Prior to the Next Dose (AUClast) of PF-06801591 - Part 1
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
- id
- OG000
- title
- Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
- description
- Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
- id
- OG001
- title
- Part 1: PF-06801591 1 mg/kg (IV)
- description
- Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
- id
- OG002
- title
- Part 1: PF-06801591 3 mg/kg (IV)
- description
- Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
- id
- OG003
- title
- Part 1: PF-06801591 10 mg/kg (IV)
- description
- Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
- id
- OG004
- title
- Part 1: PF-06801591 300 mg (Subcutaneously [SC])
- param Type
- GEOMETRIC_MEAN
- population Description
- Analysis population included all enrolled participants treated who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 1 and 24 hours post dose on Cycle 1 Day 1 in Part 1
- title
- AUClast of PF-06801591 in Part 1.
- type
- SECONDARY
- unit Of Measure
- ug*hr/mL
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Preserved source evidence · Not medical advice