NCT04299048 · OUTCOME
Serum Total Ctrough of PF-06946860
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia. · Source last updated 2023-12-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
What was measured
Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group.
Analysis population: The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.
Groups in this outcome
PF-06946860 Q3W
During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 8 |
|---|
Reported measurements
Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 8 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PF-06946860 Q3W | 10050 | 19 | Not reported | Not reported | Not reported |
|---|
Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 8 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PF-06946860 Q3W | 17010 | 16 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 8 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PF-06946860 Q3W | 20740 | 24 | Not reported | Not reported | Not reported |
|---|
Week 12
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 8 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PF-06946860 Q3W | 21310 | 32 | Not reported | Not reported | Not reported |
|---|
Week 15
Analysis denominator · Participants
| Group | Source count |
|---|
| PF-06946860 Q3W | 7 |
|---|
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| PF-06946860 Q3W | 25450 | 31 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19
- value
- 10050
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- spread
- 16
- value
- 17010
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 24
- value
- 20740
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- spread
- 32
- value
- 21310
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 31
- value
- 25450
- title
- Week 15
- description
- Ctrough was defined as the samples measured pre-dose at Weeks 3, 6, 9 and 12, and at Week 15. Serum total Ctrough was summarized by time and treatment group.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- During the 12-week treatment period, participants receive a total of 5 SC doses of PF-06946860 Q3W.
- id
- OG000
- title
- PF-06946860 Q3W
- param Type
- GEOMETRIC_MEAN
- population Description
- The analysis set included all randomized participants who received a dose of PF-06946860 and in whom at least 1 serum concentration value was reported.
- reporting Status
- POSTED
- time Frame
- Pre-dose at Weeks 3, 6, 9 and 12, and at Week 15
- title
- Serum Total Ctrough of PF-06946860
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice