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NCT04075721 · OUTCOME

Part A: Number of Participants With Treatment-Emergent Changes From Baseline in Vital Signs - Maximal Respiration Rate Increase/Decrease

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 Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change (ch) =\<5 breaths/min, \>5 - =\<10 breaths/min and \>10 breaths/min. Ic./Dc. BS RR \>=20 breaths/min, on TR ch =\<5 breaths/min, \>5 - =\<10 breaths/min and \>10 breaths/min.

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

GroupSource count
M3258 10 mg QD2
M3258 10 mg Twice Per Week4
M3258 20 mg Twice Per Week4

Reported measurements

Ic. BS RR <20 breaths/min, on TR ch =<5 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD2Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
Ic.BS RR<20 breaths/min, on TR Ch >5 - = <10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week1Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
Ic. BS RR <20 breaths/min, on TR ch >10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Ic. BS RR >=20 breaths/min, on TR ch =<5 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
IC.BS RR >=20 breaths/min, on TR ch >5 - =<10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Ic. BS RR >=20 breaths/min, on TR ch >10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Dc. BS RR <20 breaths/min, on TR ch =<5 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD2Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week4Not reportedNot reportedNot reportedNot reported
Dc. BS RR <20 breaths/min, on TR Ch >5 - =<10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Dc. BS RR <20 breaths/min, on TR ch >10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Dc. BS RR >=20 breaths/min, on TR ch =<5 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week2Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Dc.BS RR >=20 breaths/min, on TR ch >5 - =<10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Dc. BS RR >=20 breaths/min, on TR ch >10 breaths/min
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
M3258 10 mg QD0Not reportedNot reportedNot reportedNot reported
M3258 10 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
M3258 20 mg Twice Per Week0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Ic. BS RR <20 breaths/min, on TR ch =<5 breaths/min
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Ic.BS RR<20 breaths/min, on TR Ch >5 - = <10 breaths/min
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Ic. BS RR <20 breaths/min, on TR ch >10 breaths/min
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Ic. BS RR >=20 breaths/min, on TR ch =<5 breaths/min
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    IC.BS RR >=20 breaths/min, on TR ch >5 - =<10 breaths/min
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Ic. BS RR >=20 breaths/min, on TR ch >10 breaths/min
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        4
    title
    Dc. BS RR <20 breaths/min, on TR ch =<5 breaths/min
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Dc. BS RR <20 breaths/min, on TR Ch >5 - =<10 breaths/min
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Dc. BS RR <20 breaths/min, on TR ch >10 breaths/min
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Dc. BS RR >=20 breaths/min, on TR ch =<5 breaths/min
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Dc.BS RR >=20 breaths/min, on TR ch >5 - =<10 breaths/min
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Dc. BS RR >=20 breaths/min, on TR ch >10 breaths/min
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      4
    units
    Participants
description
The number of participants with treatment-emergent changes from baseline in Increase (Ic.)/Decrease (Dc.) maximal Respiration Rate (RR) were reported by using criteria: Ic./Dc. BS RR \<20 breaths per minute (breaths/min), on TR change (ch) =\<5 breaths/min, \>5 - =\<10 breaths/min and \>10 breaths/min. Ic./Dc. BS RR \>=20 breaths/min, on TR ch =\<5 breaths/min, \>5 - =\<10 breaths/min and \>10 breaths/min.
groups
  1. 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
  2. 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
  3. 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 Respiration Rate Increase/Decrease
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice