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NCT03465722 · OUTCOME

European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib

(VOYAGER) Study of Avapritinib vs Regorafenib in Patients With Locally Advanced Unresectable or Metastatic GIST · Source last updated 2022-10-06

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

Measure
MEAN
Unit
scores on a scale
Interval / dispersion
Standard Deviation
Time frame
Difference between baseline and week 12 of treatment

What was measured

The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.

Analysis population: Intent-to-Treat Population with both a baseline and a Week 12 measurements.

Groups in this outcome

Avapritinib

300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.

Regorafinib

160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).

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

Analysis denominator · Participants

GroupSource count
Avapritinib123
Regorafinib138

Reported measurements

Source class 1
Values in scores on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Avapritinib-5.724.29Not reportedNot reportedNot reported
Regorafinib-4.420.74Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        24.29
        value
        -5.7
      2. group Id
        OG001
        spread
        20.74
        value
        -4.4
denoms
  1. counts
    1. group Id
      OG000
      value
      123
    2. group Id
      OG001
      value
      138
    units
    Participants
description
The Global Health Status Score is derived from question 29 and 30 on the EORTC-QLQ-C30 tool. The change in score was assessed between baseline and week 12 in patients treated with advanced GIST treated with avapritinib compared to patients treated with regorafenib. The Global Health Status Score score range is 0 to 100 with a higher score indicating better global health status. A positive change indicates improvement in global health status.
dispersion Type
Standard Deviation
groups
  1. description
    300 mg PO QD avapritinib: Avapritinib tablets for oral administration. Avapritinib will be dosed at 300 mg once daily, continuously.
    id
    OG000
    title
    Avapritinib
  2. description
    160 mg PO QD regorafenib: Regorafenib tablets for oral administration. Regorafenib will be dosed at 160 mg once daily for 3 weeks out of every 4 weeks (ie. 3 weeks on/1 week off).
    id
    OG001
    title
    Regorafinib
param Type
MEAN
population Description
Intent-to-Treat Population with both a baseline and a Week 12 measurements.
reporting Status
POSTED
time Frame
Difference between baseline and week 12 of treatment
title
European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30). Change in Individual Scores in Patients With Advanced GIST Treated With Avapritinib Compared to Patients Treated With Regorafenib
type
SECONDARY
unit Of Measure
scores on a scale

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

Preserved source evidence · Not medical advice