NCT03261947 · OUTCOME

Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors · Source last updated 2021-09-20

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 30 days after the last dose (Up to approximately 15 months)

What was measured

Clinical laboratory tests included hematology, clinical chemistry and urinalysis. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.

Analysis population: Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

Groups in this outcome

Pancreatic Cancer Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.

Metastatic CRC Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.

sqEC Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.

sqNSCLC Cohort

TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.

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
Pancreatic Cancer Cohort	15
Metastatic CRC Cohort	35
sqEC Cohort	21
sqNSCLC Cohort	18

Reported measurements

Neutrophil Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	26.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	17.1	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	38.1	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	27.8	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
Pancreatic Cancer Cohort	20.0	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	8.6	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	42.9	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	5.6	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
Pancreatic Cancer Cohort	13.3	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	5.6	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
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	2.9	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	5.6	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
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	5.6	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
Pancreatic Cancer Cohort	0	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	2.9	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Hepatic Enzyme Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Creatinine Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	20.0	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	4.8	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Creatinine Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Urea Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Chloride Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Sodium Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	0	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	2.9	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	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
Pancreatic Cancer Cohort	0	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	5.7	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	4.8	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	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
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	5.7	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	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
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Glucose Increased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Blood Albumin Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Protein Total Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Haematocrit Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Red Blood Cell Count Decreased

Values in percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Pancreatic Cancer Cohort	6.7	Not reported	Not reported	Not reported	Not reported
Metastatic CRC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqEC Cohort	0	Not reported	Not reported	Not reported	Not reported
sqNSCLC Cohort	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
26.7
group Id
OG001
value
17.1
group Id
OG002
value
38.1
group Id
OG003
value
27.8
title
Neutrophil Count Decreased
categories
measurements
group Id
OG000
value
20.0
group Id
OG001
value
8.6
group Id
OG002
value
42.9
group Id
OG003
value
5.6
title
White Blood Cell Count Decreased
categories
measurements
group Id
OG000
value
13.3
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
5.6
title
Lymphocyte Count Decreased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
2.9
group Id
OG002
value
0
group Id
OG003
value
5.6
title
Aspartate Aminotransferase Increased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
5.6
title
Alanine Aminotransferase Increased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2.9
group Id
OG002
value
0
group Id
OG003
value
0
title
Blood Bilirubin Increased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Hepatic Enzyme Increased
categories
measurements
group Id
OG000
value
20.0
group Id
OG001
value
0
group Id
OG002
value
4.8
group Id
OG003
value
0
title
Blood Creatinine Increased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Blood Creatinine Decreased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Blood Urea Increased
categories
measurements
group Id
OG000
value
6.7
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
title
Blood Chloride Decreased
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2.9
group Id
OG002
value
0
group Id
OG003
value
0
title
Blood Sodium Decreased

denoms

counts
group Id
OG000
value
15
group Id
OG001
value
35
group Id
OG002
value
21
group Id
OG003
value
18
units
Participants

description

groups

description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
id
OG000
title
Pancreatic Cancer Cohort
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
id
OG001
title
Metastatic CRC Cohort
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
id
OG002
title
sqEC Cohort
description
TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
id
OG003
title
sqNSCLC Cohort

param Type

NUMBER

population Description

Safety Analysis Set included all participants who received any amount of study drug. As pre-specified in the protocol, this outcome measure evaluated and reported data for participants only in the Tumor-Specific Cohorts.

reporting Status

POSTED

time Frame

From first dose of the study drug up to 30 days after the last dose (Up to approximately 15 months)

title

Percentage of Participants With Clinically Significant Changes in Laboratory Values, Reported as Adverse Events in Tumor-Specific Cohorts

type

SECONDARY

unit Of Measure

percentage of participants

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Preserved source evidence · Not medical advice