NCT02004028 · OUTCOME

Number of Patients With at Least One Adverse Event

Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants · Source last updated 2024-02-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.

What was measured

Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.

Analysis population: Patients with at least one treatment-related treatment-emergent adverse events

Groups in this outcome

Cohort 1

400 mg BID for 12 Days

Cohort 2

Defactinib 400 mg BID for 35 Days

Cohort 3

Defactinib 400 mg BID for 21 Days

Cohort 4

Defactinib 100 mg BID for 21 Days

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
Cohort 1	10
Cohort 2	10
Cohort 3	10
Cohort 4	5

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Cohort 1	10	Not reported	Not reported	Not reported	Not reported
Cohort 2	10	Not reported	Not reported	Not reported	Not reported
Cohort 3	10	Not reported	Not reported	Not reported	Not reported
Cohort 4	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
10
group Id
OG003
value
5

denoms

counts
group Id
OG000
value
10
group Id
OG001
value
10
group Id
OG002
value
10
group Id
OG003
value
5
units
Participants

description

Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.

groups

description
400 mg BID for 12 Days
id
OG000
title
Cohort 1
description
Defactinib 400 mg BID for 35 Days
id
OG001
title
Cohort 2
description
Defactinib 400 mg BID for 21 Days
id
OG002
title
Cohort 3
description
Defactinib 100 mg BID for 21 Days
id
OG003
title
Cohort 4

param Type

COUNT_OF_PARTICIPANTS

population Description

Patients with at least one treatment-related treatment-emergent adverse events

reporting Status

POSTED

time Frame

Cohort 1, 40 days; Cohort 2, 42 days; Cohort 3, 28 days; Cohort 4, 28 days.

title

Number of Patients With at Least One Adverse Event

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice