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NCT02989857 · OUTCOME

Percentage of Participants With Each EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Dimension Response

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Cycle 3 Day 1

What was measured

The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Percentages are rounded off to whole number at the nearest decimal.

Analysis population: ITT population included all participants who were randomized, with the treatment group designated according to the randomization. Overall number analyzed is the number of participants available for analysis.

Groups in this outcome

AG-120

Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.

Placebo

Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.

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

Analysis denominator · Participants

GroupSource count
AG-12050
Placebo12

Reported measurements

Mobility: No Problems Walking
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12052.0Not reportedNot reportedNot reportedNot reported
Placebo41.7Not reportedNot reportedNot reportedNot reported
Mobility: Slight Problems Walking
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12028.0Not reportedNot reportedNot reportedNot reported
Placebo25.0Not reportedNot reportedNot reportedNot reported
Mobility: Moderate Problems Walking
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12016.0Not reportedNot reportedNot reportedNot reported
Placebo33.3Not reportedNot reportedNot reportedNot reported
Mobility: Severe Problems Walking
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1204.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Mobility: Unable to Walk
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1200.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Self-Care: No Problems Washing or Dressing
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12088.0Not reportedNot reportedNot reportedNot reported
Placebo83.3Not reportedNot reportedNot reportedNot reported
Self-Care: Slight Problems Washing or Dressing
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1208.0Not reportedNot reportedNot reportedNot reported
Placebo16.7Not reportedNot reportedNot reportedNot reported
Self-Care: Moderate Problems Washing or Dressing
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1202.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Self-Care: Severe Problems Washing or Dressing
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1202.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Usual Activities: No Problems Doing Usual Activities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12042.0Not reportedNot reportedNot reportedNot reported
Placebo33.3Not reportedNot reportedNot reportedNot reported
Usual Activities: Slight Problems Doing Usual Activities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12034.0Not reportedNot reportedNot reportedNot reported
Placebo41.7Not reportedNot reportedNot reportedNot reported
Usual Activities: Moderate Problems Doing Usual Activities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12016.0Not reportedNot reportedNot reportedNot reported
Placebo25.0Not reportedNot reportedNot reportedNot reported
Usual Activities: Severe Problems Doing Usual Activities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1208.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Usual Activities: Unable to do Usual Activities
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1200.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Pain/Discomfort: No Pain or Discomfort
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12040.0Not reportedNot reportedNot reportedNot reported
Placebo41.7Not reportedNot reportedNot reportedNot reported
Pain/Discomfort: Slight Pain or Discomfort
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12042.0Not reportedNot reportedNot reportedNot reported
Placebo33.3Not reportedNot reportedNot reportedNot reported
Pain/Discomfort: Moderate Pain or Discomfort
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12010.0Not reportedNot reportedNot reportedNot reported
Placebo25.0Not reportedNot reportedNot reportedNot reported
Pain/Discomfort: Severe Pain or Discomfort
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1206.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Pain/Discomfort: Extreme Pain or Discomfort
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1202.0Not reportedNot reportedNot reportedNot reported
Placebo0.0Not reportedNot reportedNot reportedNot reported
Anxiety/Depression: Not Anxious or Depressed
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12050.0Not reportedNot reportedNot reportedNot reported
Placebo33.3Not reportedNot reportedNot reportedNot reported
Anxiety/Depression: Slightly Anxious or Depressed
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-12044.0Not reportedNot reportedNot reportedNot reported
Placebo33.3Not reportedNot reportedNot reportedNot reported
Anxiety/Depression: Moderately Anxious or Depressed
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1206.0Not reportedNot reportedNot reportedNot reported
Placebo25.0Not reportedNot reportedNot reportedNot reported
Anxiety/Depression: Severely Anxious or Depressed
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
AG-1200.0Not reportedNot reportedNot reportedNot reported
Placebo8.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52.0
      2. group Id
        OG001
        value
        41.7
    title
    Mobility: No Problems Walking
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28.0
      2. group Id
        OG001
        value
        25.0
    title
    Mobility: Slight Problems Walking
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16.0
      2. group Id
        OG001
        value
        33.3
    title
    Mobility: Moderate Problems Walking
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4.0
      2. group Id
        OG001
        value
        0.0
    title
    Mobility: Severe Problems Walking
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0.0
      2. group Id
        OG001
        value
        0.0
    title
    Mobility: Unable to Walk
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        88.0
      2. group Id
        OG001
        value
        83.3
    title
    Self-Care: No Problems Washing or Dressing
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8.0
      2. group Id
        OG001
        value
        16.7
    title
    Self-Care: Slight Problems Washing or Dressing
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
      2. group Id
        OG001
        value
        0.0
    title
    Self-Care: Moderate Problems Washing or Dressing
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2.0
      2. group Id
        OG001
        value
        0.0
    title
    Self-Care: Severe Problems Washing or Dressing
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        42.0
      2. group Id
        OG001
        value
        33.3
    title
    Usual Activities: No Problems Doing Usual Activities
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        34.0
      2. group Id
        OG001
        value
        41.7
    title
    Usual Activities: Slight Problems Doing Usual Activities
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        16.0
      2. group Id
        OG001
        value
        25.0
    title
    Usual Activities: Moderate Problems Doing Usual Activities
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      12
    units
    Participants
description
The EQ-5D-5L assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Percentages are rounded off to whole number at the nearest decimal.
groups
  1. description
    Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
    id
    OG000
    title
    AG-120
  2. description
    Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
ITT population included all participants who were randomized, with the treatment group designated according to the randomization. Overall number analyzed is the number of participants available for analysis.
reporting Status
POSTED
time Frame
Cycle 3 Day 1
title
Percentage of Participants With Each EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Dimension Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice