Part A: Number of Participants With Treatment-Emergent Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
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
Time from first treatment up to 30 days after end of study intervention (assessed up to 24.3 weeks)
What was measured
The number of participants with treatment-emergent changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and greater than or equal to (\>=)3°C; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C.
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
Baseline temp. <37°C, on treatment change <1°C
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
M3258 10 mg QD
0
Not reported
Not reported
Not reported
Not reported
M3258 10 mg Twice Per Week
1
Not reported
Not reported
Not reported
Not reported
M3258 20 mg Twice Per Week
2
Not reported
Not reported
Not reported
Not reported
Baseline temp.<37°C, on treatment change 1 - <2°C
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
M3258 10 mg QD
2
Not reported
Not reported
Not reported
Not reported
M3258 10 mg Twice Per Week
0
Not reported
Not reported
Not reported
Not reported
M3258 20 mg Twice Per Week
1
Not reported
Not reported
Not reported
Not reported
Baseline temp. <37°C, on treatment change 2 - <3°C
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
M3258 10 mg QD
0
Not reported
Not reported
Not reported
Not reported
M3258 10 mg Twice Per Week
0
Not reported
Not reported
Not reported
Not reported
M3258 20 mg Twice Per Week
0
Not reported
Not reported
Not reported
Not reported
Baseline temp. <37°C, on treatment change >=3°C
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
M3258 10 mg QD
0
Not reported
Not reported
Not reported
Not reported
M3258 10 mg Twice Per Week
1
Not reported
Not reported
Not reported
Not reported
M3258 20 mg Twice Per Week
0
Not reported
Not reported
Not reported
Not reported
Baseline temp. 37 - <38°C, on treatment change <1°C
Values in Participants · Interval/dispersion: Not reported
Baseline temp. 38 - <39°C, on treatment change >=3°C
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
4
units
Participants
description
The number of participants with treatment-emergent changes from baseline in increased Body Temperature (degree Celsius \[°C\]) were reported by using criteria: Baseline temperature (temp.) less than (\<) 37°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and greater than or equal to (\>=)3°C; Baseline temp. 37 - \<38°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. 38 - \<39°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. 39-\<40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C; Baseline temp. \>=40°C, on treatment change \<1°C, 1 - \<2°C, 2 - \<3°C and \>=3°C.
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
Time from first treatment up to 30 days after end of study intervention (assessed up to 24.3 weeks)
title
Part A: Number of Participants With Treatment-Emergent Changes From Baseline in Vital Signs - Maximal Body Temperature Increase
Triangle