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NCT03261947 · OUTCOME

Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements, 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

Vital signs included assessments of systolic and diastolic blood pressure (BP), heart rate (HR), and body temperature. 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

GroupSource count
Pancreatic Cancer Cohort15
Metastatic CRC Cohort35
sqEC Cohort21
sqNSCLC Cohort18

Reported measurements

Orthostatic Hypotension
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pancreatic Cancer Cohort0Not reportedNot reportedNot reportedNot reported
Metastatic CRC Cohort2.9Not reportedNot reportedNot reportedNot reported
sqEC Cohort0Not reportedNot reportedNot reportedNot reported
sqNSCLC Cohort0Not reportedNot reportedNot reportedNot reported
Tachycardia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pancreatic Cancer Cohort0Not reportedNot reportedNot reportedNot reported
Metastatic CRC Cohort5.7Not reportedNot reportedNot reportedNot reported
sqEC Cohort0Not reportedNot reportedNot reportedNot reported
sqNSCLC Cohort0Not reportedNot reportedNot reportedNot reported
Bradycardia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pancreatic Cancer Cohort0Not reportedNot reportedNot reportedNot reported
Metastatic CRC Cohort2.9Not reportedNot reportedNot reportedNot reported
sqEC Cohort0Not reportedNot reportedNot reportedNot reported
sqNSCLC Cohort0Not reportedNot reportedNot reportedNot reported
Atrial Fibrillation
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pancreatic Cancer Cohort0Not reportedNot reportedNot reportedNot reported
Metastatic CRC Cohort2.9Not reportedNot reportedNot reportedNot reported
sqEC Cohort0Not reportedNot reportedNot reportedNot reported
sqNSCLC Cohort0Not reportedNot reportedNot reportedNot reported
Increase in HR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pancreatic Cancer Cohort0Not reportedNot reportedNot reportedNot reported
Metastatic CRC Cohort2.9Not reportedNot reportedNot reportedNot reported
sqEC Cohort0Not reportedNot reportedNot reportedNot reported
sqNSCLC Cohort0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Orthostatic Hypotension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5.7
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Tachycardia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Bradycardia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Atrial Fibrillation
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2.9
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Increase in HR
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      35
    3. group Id
      OG002
      value
      21
    4. group Id
      OG003
      value
      18
    units
    Participants
description
Vital signs included assessments of systolic and diastolic blood pressure (BP), heart rate (HR), and body temperature. The investigator determined if the results were clinically significant. Only those categories were reported which are clinically significant at post Baseline.
groups
  1. 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
  2. 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
  3. 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
  4. 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 Vital Sign Measurements, 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