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NCT01001377 · OUTCOME

Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer · Source last updated 2022-09-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
LEAST_SQUARES_MEAN
Unit
scores on a scale
Interval / dispersion
95% Confidence Interval
Time frame
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.

What was measured

The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.

Analysis population: Patient reported outcomes (PRO) analysis set participants with available data

Groups in this outcome

Cetuximab

Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.

Panitumumab

Panitumumab 6 mg/kg IV every 14 days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cetuximab149
Panitumumab142

Reported measurements

Source class 1
Values in scores on a scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cetuximab3.9782Not reported0.88427.0722Not reported
Panitumumab2.3037Not reported-0.85325.4605Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -4.9331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5841
    estimate Comment
    A positive difference between the treatment groups favors the panitumumab group.
    group Description
    Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    LS Mean Difference
    param Value
    -1.6745
Complete source fields
analyses
  1. ci Lower Limit
    -4.9331
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5841
    estimate Comment
    A positive difference between the treatment groups favors the panitumumab group.
    group Description
    Repeated measures mixed model includes treatment, geographic region, ECOG score, assessment week, and treatment by assessment week interaction as fixed effects, and subjects a random effect. An unstructured covariance matrix is used in the mixed model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    param Type
    LS Mean Difference
    param Value
    -1.6745
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.8842
        upper Limit
        7.0722
        value
        3.9782
      2. group Id
        OG001
        lower Limit
        -0.8532
        upper Limit
        5.4605
        value
        2.3037
denoms
  1. counts
    1. group Id
      OG000
      value
      149
    2. group Id
      OG001
      value
      142
    units
    Participants
description
The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
dispersion Type
95% Confidence Interval
groups
  1. description
    Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
    id
    OG000
    title
    Cetuximab
  2. description
    Panitumumab 6 mg/kg IV every 14 days.
    id
    OG001
    title
    Panitumumab
param Type
LEAST_SQUARES_MEAN
population Description
Patient reported outcomes (PRO) analysis set participants with available data
reporting Status
POSTED
time Frame
From Study Day 1 through the last day of treatment or disease progression, up to Week 85.
title
Change From Baseline in EuroQOL 5 Dimension (EQ-5D) Visual Analog Scale (VAS)
type
SECONDARY
unit Of Measure
scores on a scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice