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NCT03353753 · OUTCOME

Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale

Phase 3 Study of DCC-2618 vs Placebo in Advanced GIST Patients Who Have Been Treated With Prior Anticancer Therapies · Source last updated 2022-11-21

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

Measure
MEAN
Unit
Units on a Scale
Interval / dispersion
Standard Deviation
Time frame
From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)

What was measured

Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.

Analysis population: ITT Population

Groups in this outcome

Ripretinib

Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

Placebo

Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).

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

Analysis denominator · Participants

GroupSource count
Ripretinib85
Placebo43

Reported measurements

Source class 1
Values in Units on a Scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Ripretinib3.720.36Not reportedNot reportedNot reported
Placebo-8.919.31Not reportedNot reportedNot reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.004
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        20.36
        value
        3.7
      2. group Id
        OG001
        spread
        19.31
        value
        -8.9
denoms
  1. counts
    1. group Id
      OG000
      value
      85
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Change from baseline in EuroQol Visual Analogue Scale. For the ripretinib arm the minimum and maximum for the outcome were -43 to 91; the placebo arm had a range of -68 to 23. The higher value represents a higher quality of life in disease-related symptoms.
dispersion Type
Standard Deviation
groups
  1. description
    Ripretinib (150 mg) once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    OG000
    title
    Ripretinib
  2. description
    Placebo once daily in 28-day cycles until disease progression by Independent Radiologic Review (IRR) in patients with advanced gastrointestinal stromal tumors (GIST) who have received treatment with prior therapies (therapies must include treatment with imatinib, sunitinib, and regorafenib).
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
ITT Population
reporting Status
POSTED
time Frame
From the date of randomization (Baseline) to Cycle 2 Day 1 (Month 2)
title
Quality of Life & Disease-Related Symptoms - EuroQol Visual Analogue Scale
type
SECONDARY
unit Of Measure
Units on a Scale

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

Preserved source evidence · Not medical advice