NCT02989857 · OUTCOME

Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events

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: From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years)

What was measured

The laboratory parameters evaluated by the investigator included hematology and chemistry. Laboratory abnormalities reported in this endpoint are Grade 3 or higher adverse events. Grading categories were determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03.

Analysis population: SAS included all participants who received at least one dose of study drug (AG-120 or Placebo).

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.

After Crossover to AG-120

Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.

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	123
Placebo	59
After Crossover to AG-120	43

Reported measurements

Anaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	7.3	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	9.3	Not reported	Not reported	Not reported	Not reported

Platelet Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	2.4	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	2.3	Not reported	Not reported	Not reported	Not reported

Neutrophil Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.6	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

White Blood Cell Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.6	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Lymphocyte Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	3.4	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Thrombocytopenia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Blood Loss Anaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Blood Bilirubin Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	5.7	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	7.0	Not reported	Not reported	Not reported	Not reported

Hyponatraemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	5.7	Not reported	Not reported	Not reported	Not reported
Placebo	10.2	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	2.3	Not reported	Not reported	Not reported	Not reported

Aspartate Aminotransferase Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	4.9	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	4.7	Not reported	Not reported	Not reported	Not reported

Hypophosphataemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.3	Not reported	Not reported	Not reported	Not reported
Placebo	5.1	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	4.7	Not reported	Not reported	Not reported	Not reported

Hyperbilirubinaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	3.3	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Hyperkalaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	2.4	Not reported	Not reported	Not reported	Not reported
Placebo	3.4	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	2.3	Not reported	Not reported	Not reported	Not reported

Blood Alkaline Phosphatase Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	2.4	Not reported	Not reported	Not reported	Not reported
Placebo	5.1	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Alanine Aminotransferase Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.6	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	2.3	Not reported	Not reported	Not reported	Not reported

Hypoalbuminaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	1.6	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Gamma-glutamyltransferase Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Hypercalcaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Hyperuricaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Hypokalaemia

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	2.3	Not reported	Not reported	Not reported	Not reported

Transaminases Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
AG-120	0.8	Not reported	Not reported	Not reported	Not reported
Placebo	0.0	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Blood Uric Acid Increased

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	1.7	Not reported	Not reported	Not reported	Not reported
After Crossover to AG-120	0.0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
7.3
group Id
OG001
value
0.0
group Id
OG002
value
9.3
title
Anaemia
categories
measurements
group Id
OG000
value
2.4
group Id
OG001
value
0.0
group Id
OG002
value
2.3
title
Platelet Count Decreased
categories
measurements
group Id
OG000
value
1.6
group Id
OG001
value
0.0
group Id
OG002
value
0.0
title
Neutrophil Count Decreased
categories
measurements
group Id
OG000
value
1.6
group Id
OG001
value
0.0
group Id
OG002
value
0.0
title
White Blood Cell Count Decreased
categories
measurements
group Id
OG000
value
0.8
group Id
OG001
value
3.4
group Id
OG002
value
0.0
title
Lymphocyte Count Decreased
categories
measurements
group Id
OG000
value
0.8
group Id
OG001
value
0.0
group Id
OG002
value
0.0
title
Thrombocytopenia
categories
measurements
group Id
OG000
value
0.8
group Id
OG001
value
0.0
group Id
OG002
value
0.0
title
Blood Loss Anaemia
categories
measurements
group Id
OG000
value
5.7
group Id
OG001
value
1.7
group Id
OG002
value
7.0
title
Blood Bilirubin Increased
categories
measurements
group Id
OG000
value
5.7
group Id
OG001
value
10.2
group Id
OG002
value
2.3
title
Hyponatraemia
categories
measurements
group Id
OG000
value
4.9
group Id
OG001
value
1.7
group Id
OG002
value
4.7
title
Aspartate Aminotransferase Increased
categories
measurements
group Id
OG000
value
3.3
group Id
OG001
value
5.1
group Id
OG002
value
4.7
title
Hypophosphataemia
categories
measurements
group Id
OG000
value
3.3
group Id
OG001
value
0.0
group Id
OG002
value
0.0
title
Hyperbilirubinaemia

denoms

counts
group Id
OG000
value
123
group Id
OG001
value
59
group Id
OG002
value
43
units
Participants

description

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
description
Participants who experienced disease progression and received placebo were allowed to cross over to receive AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle for up to approximately 32 months.
id
OG002
title
After Crossover to AG-120

param Type

NUMBER

population Description

SAS included all participants who received at least one dose of study drug (AG-120 or Placebo).

reporting Status

POSTED

time Frame

From first dose of the study drug up to end of treatment visit for each intervention (Up to approximately 4 Years)

title

Percentage of Participants Who Experienced Laboratory Abnormalities Reported as Grade 3 or Higher Adverse Events

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice