NCT04803305 · OUTCOME
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 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, 4, 5 and 6
What was measured
The Cancer-Related Cachexia Symptom Assessment-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue.
In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue 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 | 1.84 | Not reported | -1.47 | 5.16 | Not reported |
|---|
| PF-06946860 200mg Q3W | 1.52 | Not reported | -0.57 | 3.60 | 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 | 0.04 | Not reported | -2.71 | 2.80 | Not reported |
|---|
| PF-06946860 200mg Q3W | -2.12 | Not reported | -3.91 | -0.34 | 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 | -1.21 | Not reported | -2.33 | -0.09 | Not reported |
|---|
| PF-06946860 200mg Q3W | -0.49 | Not reported | -1.23 | 0.25 | Not reported |
|---|
Week 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Placebo | 5 |
|---|
| PF-06946860 200mg Q3W | 9 |
|---|
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Placebo | -1.00 | Not reported | -2.40 | 0.40 | Not reported |
|---|
| PF-06946860 200mg Q3W | -0.55 | Not reported | -1.57 | 0.48 | 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 | -0.92 | Not reported | -2.47 | 0.63 | Not reported |
|---|
| PF-06946860 200mg Q3W | -0.24 | Not reported | -1.31 | 0.82 | 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 | -1.13 | Not reported | -2.40 | 0.15 | Not reported |
|---|
| PF-06946860 200mg Q3W | 0.74 | Not reported | -0.09 | 1.57 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -4.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.53
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.98
- estimate Comment
- Week 1
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -0.32
- ci Lower Limit
- -5.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.16
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.58
- estimate Comment
- Week 2
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -2.16
- ci Lower Limit
- -0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.76
- estimate Comment
- Week 3
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.72
- ci Lower Limit
- -1.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.20
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.97
- estimate Comment
- Week 4
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.45
- ci Lower Limit
- -1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.57
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.04
- estimate Comment
- Week 5
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.68
- ci Lower Limit
- 0.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.39
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.84
- estimate Comment
- Week 6
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.86
Complete source fields
- analyses
- ci Lower Limit
- -4.18
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.53
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.98
- estimate Comment
- Week 1
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -0.32
- ci Lower Limit
- -5.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.16
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.58
- estimate Comment
- Week 2
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- -2.16
- ci Lower Limit
- -0.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.06
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.76
- estimate Comment
- Week 3
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.72
- ci Lower Limit
- -1.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.20
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.97
- estimate Comment
- Week 4
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.45
- ci Lower Limit
- -1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 2.57
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 1.04
- estimate Comment
- Week 5
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 0.68
- ci Lower Limit
- 0.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 3.39
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.84
- estimate Comment
- Week 6
- non Inferiority Type
- SUPERIORITY
- param Type
- Mean Difference (Final Values)
- param Value
- 1.86
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.47
- upper Limit
- 5.16
- value
- 1.84
- group Id
- OG001
- lower Limit
- -0.57
- upper Limit
- 3.60
- value
- 1.52
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Week 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.71
- upper Limit
- 2.80
- value
- 0.04
- group Id
- OG001
- lower Limit
- -3.91
- upper Limit
- -0.34
- value
- -2.12
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.33
- upper Limit
- -0.09
- value
- -1.21
- group Id
- OG001
- lower Limit
- -1.23
- upper Limit
- 0.25
- value
- -0.49
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- Week 3
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.40
- upper Limit
- 0.40
- value
- -1.00
- group Id
- OG001
- lower Limit
- -1.57
- upper Limit
- 0.48
- value
- -0.55
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.47
- upper Limit
- 0.63
- value
- -0.92
- group Id
- OG001
- lower Limit
- -1.31
- upper Limit
- 0.82
- value
- -0.24
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 9
- units
- Participants
- title
- Week 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.40
- upper Limit
- 0.15
- value
- -1.13
- group Id
- OG001
- lower Limit
- -0.09
- upper Limit
- 1.57
- value
- 0.74
- 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-Fatigue was a self-reported questionnaire that measured the severity of fatigue. The measure consisted of 1 question that asked study participants to rate their fatigue over the past 7 days from 0-"no fatigue" to 10-"worst possible fatigue", where higher score indicated worse fatigue.
In this OM, changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Fatigue 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, 4, 5 and 6
- title
- Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Fatigue Score at Weeks 1, 2, 3, 4, 5 and 6 in Part A
- type
- SECONDARY
- unit Of Measure
- Units on a Scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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