NCT04803305 · OUTCOME
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia · Source last updated 2024-01-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- Units on a Scale
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Baseline, Weeks 1, 2, 3, 5 and 6
What was measured
The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite.
In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.
Analysis population: The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.
Groups in this outcome
Placebo
Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.
PF-06946860 200mg Q3W
Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
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 |
|---|
| Placebo | 6 |
|---|
| PF-06946860 200mg Q3W | 12 |
|---|
Reported measurements
Week 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 3 |
|---|
| PF-06946860 200mg Q3W | 8 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 0.99 | Not reported | -0.66 | 2.64 | Not reported |
|---|
| PF-06946860 200mg Q3W | 2.19 | Not reported | 1.17 | 3.20 | Not reported |
|---|
Week 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 4 |
|---|
| PF-06946860 200mg Q3W | 9 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 1.11 | Not reported | -0.03 | 2.25 | Not reported |
|---|
| PF-06946860 200mg Q3W | 2.21 | Not reported | 1.45 | 2.98 | Not reported |
|---|
Week 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 5 |
|---|
| PF-06946860 200mg Q3W | 11 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 1.27 | Not reported | -0.35 | 2.89 | Not reported |
|---|
| PF-06946860 200mg Q3W | 2.30 | Not reported | 1.20 | 3.41 | Not reported |
|---|
Week 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 4 |
|---|
| PF-06946860 200mg Q3W | 9 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 1.95 | Not reported | 0.27 | 3.63 | Not reported |
|---|
| PF-06946860 200mg Q3W | 1.95 | Not reported | 0.82 | 3.08 | Not reported |
|---|
Week 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 4 |
|---|
| PF-06946860 200mg Q3W | 9 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | 2.41 | Not reported | 0.49 | 4.33 | Not reported |
|---|
| PF-06946860 200mg Q3W | 1.61 | Not reported | 0.32 | 2.90 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.15
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.07
- estimate Comment
- Week 1
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.20
- ci Lower Limit
- -0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.49
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.78
- estimate Comment
- Week 2
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.10
- ci Lower Limit
- -0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.99
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.11
- estimate Comment
- Week 3
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.03
- ci Lower Limit
- -2.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.02
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.14
- estimate Comment
- Week 5
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.00
- ci Lower Limit
- -3.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.51
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.29
- estimate Comment
- Week 6
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -0.80
Complete source fields
- analyses
- ci Lower Limit
- -0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.15
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.07
- estimate Comment
- Week 1
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.20
- ci Lower Limit
- -0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.49
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.78
- estimate Comment
- Week 2
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.10
- ci Lower Limit
- -0.93
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.99
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.11
- estimate Comment
- Week 3
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.03
- ci Lower Limit
- -2.02
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.02
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.14
- estimate Comment
- Week 5
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.00
- ci Lower Limit
- -3.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.51
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.29
- estimate Comment
- Week 6
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -0.80
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.66
- upper Limit
- 2.64
- value
- 0.99
- group Id
- OG001
- lower Limit
- 1.17
- upper Limit
- 3.20
- value
- 2.19
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.03
- upper Limit
- 2.25
- value
- 1.11
- group Id
- OG001
- lower Limit
- 1.45
- upper Limit
- 2.98
- value
- 2.21
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.35
- upper Limit
- 2.89
- value
- 1.27
- group Id
- OG001
- lower Limit
- 1.20
- upper Limit
- 3.41
- value
- 2.30
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.27
- upper Limit
- 3.63
- value
- 1.95
- group Id
- OG001
- lower Limit
- 0.82
- upper Limit
- 3.08
- value
- 1.95
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.49
- upper Limit
- 4.33
- value
- 2.41
- group Id
- OG001
- lower Limit
- 0.32
- upper Limit
- 2.90
- value
- 1.61
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 6
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- The Cancer-Related Cachexia Symptom Assessment-Appetite was a self-reported questionnaire that measured the severity of anorexia. The measure consisted of 1 question that asked study participants to rate their appetite over the past 7 days from 0-"no appetite" to 10-"very good appetite", where higher score indicated better appetite.
In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score were summarized descriptively by treatment group and timepoint.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.
- id
- OG000
- title
- Placebo
- description
- Participants received PF-06946860 200 mg during the 6-week double-blind phase (Part A) Q3W SC.
- id
- OG001
- title
- PF-06946860 200mg Q3W
- param Type
- LEAST_SQUARES_MEAN
- population Description
- The analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. The number analyzed at each timepoint in each group was the number of participants with non-missing data in the analysis set at a given visit. Number of participants analyzed = number of participants evaluable for this OM, number analyzed = number of participants evaluable at each timepoint for each treatment group.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 1, 2, 3, 5 and 6
- title
- Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Weeks 1, 2, 3, 5 and 6 in Part A
- type
- SECONDARY
- unit Of Measure
- Units on a Scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle