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NCT02989857 · OUTCOME

Percentage of Participants With Severity Based on HRQOL: Patient Global Impression of Severity (PGI-S)

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 anchor-based questionnaire PGI-S contains the following 3 items (the severity of the physical functioning decline over the past week, the severity of the appetite decrease over the past week, and the severity of the pain over the past week). The PGI-S was measured using the possible outcomes none, mild, moderate, severe, and very severe. 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 Decline: Cycle 2 Day 1: None

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	55.2	Not reported	Not reported	Not reported	Not reported
Placebo	31.8	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 2 Day 1: Mild

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	23.9	Not reported	Not reported	Not reported	Not reported
Placebo	27.3	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 2 Day 1: Moderate

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	16.4	Not reported	Not reported	Not reported	Not reported
Placebo	31.8	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 2 Day 1: Severe

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	3.0	Not reported	Not reported	Not reported	Not reported
Placebo	9.1	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 2 Day 1: Very Severe

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 Decline: Cycle 3 Day 1: None

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	70.6	Not reported	Not reported	Not reported	Not reported
Placebo	75.0	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 3 Day 1: Mild

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	16.7	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 3 Day 1: Moderate

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	8.3	Not reported	Not reported	Not reported	Not reported

Physical Decline: Cycle 3 Day 1: Severe

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 Decline: Cycle 3 Day 1: very Severe

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 Decrease: Cycle 2 Day 1: None

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	53.7	Not reported	Not reported	Not reported	Not reported
Placebo	45.5	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 2 Day 1: Mild

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	32.8	Not reported	Not reported	Not reported	Not reported
Placebo	13.6	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 2 Day 1: Moderate

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	36.4	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 2 Day 1: Severe

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

Appetite Decrease: Cycle 2 Day 1: Very Severe

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 Decrease: Cycle 3 Day 1: None

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	70.6	Not reported	Not reported	Not reported	Not reported
Placebo	58.3	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 3 Day 1: Mild

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	25.0	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 3 Day 1: Moderate

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	16.7	Not reported	Not reported	Not reported	Not reported

Appetite Decrease: Cycle 3 Day 1: Severe

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 Decrease: Cycle 3 Day 1: Very Severe

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 Severity: Cycle 2 Day 1: None

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	32.8	Not reported	Not reported	Not reported	Not reported
Placebo	31.8	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 2 Day 1: Mild

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	13.6	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 2 Day 1: Moderate

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	23.9	Not reported	Not reported	Not reported	Not reported
Placebo	40.9	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 2 Day 1: Severe

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	9.1	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 2 Day 1: Very Severe

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	4.5	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 3 Day 1: None

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	39.2	Not reported	Not reported	Not reported	Not reported
Placebo	33.3	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 3 Day 1: Mild

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	35.3	Not reported	Not reported	Not reported	Not reported
Placebo	25.0	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 3 Day 1: Moderate

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	17.6	Not reported	Not reported	Not reported	Not reported
Placebo	41.7	Not reported	Not reported	Not reported	Not reported

Pain Severity: Cycle 3 Day 1: Severe

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

Pain Severity: Cycle 3 Day 1: Very Severe

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

Complete source fields

classes

categories
measurements
group Id
OG000
value
55.2
group Id
OG001
value
31.8
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Decline: Cycle 2 Day 1: None
categories
measurements
group Id
OG000
value
23.9
group Id
OG001
value
27.3
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Decline: Cycle 2 Day 1: Mild
categories
measurements
group Id
OG000
value
16.4
group Id
OG001
value
31.8
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Decline: Cycle 2 Day 1: Moderate
categories
measurements
group Id
OG000
value
3.0
group Id
OG001
value
9.1
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Physical Decline: Cycle 2 Day 1: Severe
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 Decline: Cycle 2 Day 1: Very Severe
categories
measurements
group Id
OG000
value
70.6
group Id
OG001
value
75.0
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Decline: Cycle 3 Day 1: None
categories
measurements
group Id
OG000
value
11.8
group Id
OG001
value
16.7
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Decline: Cycle 3 Day 1: Mild
categories
measurements
group Id
OG000
value
15.7
group Id
OG001
value
8.3
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Decline: Cycle 3 Day 1: Moderate
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 Decline: Cycle 3 Day 1: Severe
categories
measurements
group Id
OG000
value
0.0
group Id
OG001
value
0.0
denoms
counts
group Id
OG000
value
51
group Id
OG001
value
12
units
Participants
title
Physical Decline: Cycle 3 Day 1: very Severe
categories
measurements
group Id
OG000
value
53.7
group Id
OG001
value
45.5
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Appetite Decrease: Cycle 2 Day 1: None
categories
measurements
group Id
OG000
value
32.8
group Id
OG001
value
13.6
denoms
counts
group Id
OG000
value
67
group Id
OG001
value
22
units
Participants
title
Appetite Decrease: Cycle 2 Day 1: Mild

denoms

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

description

The anchor-based questionnaire PGI-S contains the following 3 items (the severity of the physical functioning decline over the past week, the severity of the appetite decrease over the past week, and the severity of the pain over the past week). The PGI-S was measured using the possible outcomes none, mild, moderate, severe, and very severe. 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 Severity Based on HRQOL: Patient Global Impression of Severity (PGI-S)

type

SECONDARY

unit Of Measure

percentage of participants

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

Preserved source evidence · Not medical advice