NCT04075721 · OUTCOME

Part A: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Outside of Dose-Limiting Toxicity (DLT) Period That Safety Monitoring Committee Deems Relevant for Determination of the Maximum Tolerated Dose

First in Human Dose Escalation of M3258 as a Single Agent and Expansion Study of M3258 in Combination With Dexamethasone · Source last updated 2023-03-24

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: Day 29 up to 20.1 weeks

What was measured

Adverse Event (AE): any untoward medical occurrence in a participant administered with a study drug, which does not necessarily have a causal relationship with this treatment. TEAEs: events that started from first dose of study intervention to 30 days after end of study intervention, or the cutoff date, whichever occurred first. TEAEs included both serious TEAEs (Serious AE: AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect) and non-serious TEAEs. TRAEs are defined as those AEs which are reasonably related to the study intervention.

Analysis population: Safety analysis set included all participants who were administered any dose of the study medication.

Groups in this outcome

M3258 10 mg QD

Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.

M3258 10 mg Twice Per Week

Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.

M3258 20 mg Twice Per Week

Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.

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
M3258 10 mg QD	2
M3258 10 mg Twice Per Week	4
M3258 20 mg Twice Per Week	4

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
M3258 10 mg QD	Not reported	Not reported	Not reported	Not reported
M3258 10 mg Twice Per Week	Not reported	Not reported	Not reported	Not reported
M3258 20 mg Twice Per Week	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
4
units
Participants

description

groups

description
Participants received M3258 at a dose of 10 milligrams (mg) orally, once daily (QD) until disease progression.
id
OG000
title
M3258 10 mg QD
description
Participants received M3258 at a dose of 10 mg orally, twice per week on Day 1 and Day 4 until disease progression.
id
OG001
title
M3258 10 mg Twice Per Week
description
Participants received M3258 at a dose of 20 mg orally, twice per week on Day 1 and Day 4 until disease progression.
id
OG002
title
M3258 20 mg Twice Per Week

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set included all participants who were administered any dose of the study medication.

reporting Status

POSTED

time Frame

Day 29 up to 20.1 weeks

title

Part A: Number of Participants With Treatment-Emergent Adverse Event (TEAEs) Outside of Dose-Limiting Toxicity (DLT) Period That Safety Monitoring Committee Deems Relevant for Determination of the Maximum Tolerated Dose

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice