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NCT02989857 · OUTCOME

Percentage of Participants With Change Based on HRQOL: Patient Global Impression of Change (PGI-C)

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 2 Day 1 and Cycle 3 Day 1

What was measured

The PGI-C is a self-rated evaluative instrument for assessment across 3 domains (physical function, appetite loss, and pain). The PGI-C is measured using a 7-point Likert scale, with 6= very much better, 5= moderately better, 4= a little better, 3= no change, 2= a little worse, 1= moderately worse, and 0= very much worse. A lower score indicates a worse outcome. 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. Number analyzed is the number of participants available for analysis at the given timepoint.

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

Group	Source count
AG-120	67
Placebo	22

Reported measurements

Physical Change: Cycle 2 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.5	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	4.5	Not reported	Not reported	Not reported	Not reported
Placebo	13.6	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	22.4	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	38.8	Not reported	Not reported	Not reported	Not reported
Placebo	27.3	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	22.4	Not reported	Not reported	Not reported	Not reported
Placebo	36.4	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	9.0	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 2 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.5	Not reported	Not reported	Not reported	Not reported
Placebo	4.5	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	2.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	5.9	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.9	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	41.2	Not reported	Not reported	Not reported	Not reported
Placebo	58.3	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	29.4	Not reported	Not reported	Not reported	Not reported
Placebo	16.7	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	15.7	Not reported	Not reported	Not reported	Not reported
Placebo	16.7	Not reported	Not reported	Not reported	Not reported

Physical Change: Cycle 3 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	2.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.5	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	4.5	Not reported	Not reported	Not reported	Not reported
Placebo	4.5	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	20.9	Not reported	Not reported	Not reported	Not reported
Placebo	18.2	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	50.7	Not reported	Not reported	Not reported	Not reported
Placebo	45.5	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	13.4	Not reported	Not reported	Not reported	Not reported
Placebo	13.6	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	7.5	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 2 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.5	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	5.9	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	5.9	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	64.7	Not reported	Not reported	Not reported	Not reported
Placebo	50.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	11.8	Not reported	Not reported	Not reported	Not reported
Placebo	25.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	7.8	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Appetite Change: Cycle 3 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.9	Not reported	Not reported	Not reported	Not reported
Placebo	16.7	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	9.0	Not reported	Not reported	Not reported	Not reported
Placebo	13.6	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	9.0	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	64.2	Not reported	Not reported	Not reported	Not reported
Placebo	54.5	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	7.5	Not reported	Not reported	Not reported	Not reported
Placebo	18.2	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	10.4	Not reported	Not reported	Not reported	Not reported
Placebo	4.5	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 2 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	67
Placebo	22

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: Very Much Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.0	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: Moderately Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.9	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: A Little Worse

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	11.8	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: No Change

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	60.8	Not reported	Not reported	Not reported	Not reported
Placebo	66.7	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: A Little Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	7.8	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: Moderately Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	11.8	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Pain Change: Cycle 3 Day 1: Very Much Better

Analysis denominator · Participants

Group	Source count
AG-120	51
Placebo	12

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.9	Not reported	Not reported	Not reported	Not reported
Placebo	8.3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1.5
group Id
OG001
value
0.0
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: Very Much Worse
categories
measurements
group Id
OG000
value
4.5
group Id
OG001
value
13.6
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: Moderately Worse
categories
measurements
group Id
OG000
value
22.4
group Id
OG001
value
9.1
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: A Little Worse
categories
measurements
group Id
OG000
value
38.8
group Id
OG001
value
27.3
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: No Change
categories
measurements
group Id
OG000
value
22.4
group Id
OG001
value
36.4
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: A Little Better
categories
measurements
group Id
OG000
value
9.0
group Id
OG001
value
9.1
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: Moderately Better
categories
measurements
group Id
OG000
value
1.5
group Id
OG001
value
4.5
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Change: Cycle 2 Day 1: Very Much Better
categories
measurements
group Id
OG000
value
2.0
group Id
OG001
value
0.0
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Change: Cycle 3 Day 1: Very Much Worse
categories
measurements
group Id
OG000
value
5.9
group Id
OG001
value
0.0
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Change: Cycle 3 Day 1: Moderately Worse
categories
measurements
group Id
OG000
value
3.9
group Id
OG001
value
8.3
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Change: Cycle 3 Day 1: A Little Worse
categories
measurements
group Id
OG000
value
41.2
group Id
OG001
value
58.3
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Change: Cycle 3 Day 1: No Change
categories
measurements
group Id
OG000
value
29.4
group Id
OG001
value
16.7
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Change: Cycle 3 Day 1: A Little Better

denoms

counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants

description

The PGI-C is a self-rated evaluative instrument for assessment across 3 domains (physical function, appetite loss, and pain). The PGI-C is measured using a 7-point Likert scale, with 6= very much better, 5= moderately better, 4= a little better, 3= no change, 2= a little worse, 1= moderately worse, and 0= very much worse. A lower score indicates a worse outcome. Percentages are rounded off to whole number at the nearest decimal.

groups

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
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. Number analyzed is the number of participants available for analysis at the given timepoint.

reporting Status

POSTED

time Frame

Cycle 2 Day 1 and Cycle 3 Day 1

title

Percentage of Participants With Change Based on HRQOL: Patient Global Impression of Change (PGI-C)

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice