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NCT04803305 · OUTCOME

Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 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, Week 4

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 Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.

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 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 analyzed = number of participants evaluable for this OM in 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

GroupSource count
Placebo5
PF-06946860 200mg Q3W9

Reported measurements

Source class 1
Values in Units on a Scale · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo2.45Not reported1.013.88Not reported
PF-06946860 200mg Q3W1.84Not reported0.792.90Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -2.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.18
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.01
    estimate Comment
    Week 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    -0.60
Complete source fields
analyses
  1. ci Lower Limit
    -2.38
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    1.18
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.01
    estimate Comment
    Week 4
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Mean Difference (Final Values)
    param Value
    -0.60
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.01
        upper Limit
        3.88
        value
        2.45
      2. group Id
        OG001
        lower Limit
        0.79
        upper Limit
        2.90
        value
        1.84
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      9
    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 Outcome Measure (OM), changes from baseline in the Cancer-Related Cachexia Symptom Assessment-Appetite score at Week 4 were summarized descriptively by treatment group.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants received placebo during the 6-week double-blind phase (Part A) Q3W SC.
    id
    OG000
    title
    Placebo
  2. 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 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 analyzed = number of participants evaluable for this OM in each treatment group.
reporting Status
POSTED
time Frame
Baseline, Week 4
title
Change From Baseline in Cancer-Related Cachexia Symptom Assessment in Appetite Score at Week 4 in Part A
type
PRIMARY
unit Of Measure
Units on a Scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice