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NCT03922100 · OUTCOME

Treatment-emergent Adverse Events (TEAEs) Graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0 Criteria

Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML · Source last updated 2026-03-18

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
Adverse events were collected from screening visit and assessed up to 18 months

What was measured

TEAE with maximum Common Terminology Criteria (CTC) grade (graded by NCI CTCAE Version 5.0) experienced by each participant is presented. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented here. Phase 2 started before Phase 1 completed. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.

Analysis population: Treated patient population: The treated patient population consists of all enrolled participants who actually receive at least one treatment administration. This population was evaluated in the analysis of patient disposition, baseline characteristics, treatment exposure, efficacy and safety.

Groups in this outcome

Phase 1, Schedule A: 20 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 40 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 80 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 120 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.

Phase 1, Schedule A: 180 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 270 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 300 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule A: 360 mg

All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle

Phase 1, Schedule B: 120 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle

Phase 1, Schedule B: 180 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.

Phase 1, Schedule B: 250 mg

All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle

Phase 2, Schedule B:360+150 mg

NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 1, Schedule A: 20 mg3
Phase 1, Schedule A: 40 mg3
Phase 1, Schedule A: 80 mg3
Phase 1, Schedule A: 120 mg3
Phase 1, Schedule A: 180 mg3
Phase 1, Schedule A: 270 mg4
Phase 1, Schedule A: 300 mg10
Phase 1, Schedule A: 360 mg3
Phase 1, Schedule B: 120 mg4
Phase 1, Schedule B: 180 mg6
Phase 1, Schedule B: 250 mg4
Phase 2, Schedule B:360+150 mg15

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1, Schedule A: 20 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 40 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 80 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 120 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 180 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 270 mg4Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 300 mg10Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule A: 360 mg3Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 120 mg4Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 180 mg6Not reportedNot reportedNot reportedNot reported
Phase 1, Schedule B: 250 mg4Not reportedNot reportedNot reportedNot reported
Phase 2, Schedule B:360+150 mg15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        10
      8. group Id
        OG007
        value
        3
      9. group Id
        OG008
        value
        4
      10. group Id
        OG009
        value
        6
      11. group Id
        OG010
        value
        4
      12. group Id
        OG011
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      3
    9. group Id
      OG008
      value
      4
    10. group Id
      OG009
      value
      6
    11. group Id
      OG010
      value
      4
    12. group Id
      OG011
      value
      15
    units
    Participants
description
TEAE with maximum Common Terminology Criteria (CTC) grade (graded by NCI CTCAE Version 5.0) experienced by each participant is presented. If an AE was reported for a participant more than once during treatment, the worst CTC Grade is presented here. Phase 2 started before Phase 1 completed. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4 Life-threatening consequences; urgent intervention indicated.
groups
  1. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 20 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG000
    title
    Phase 1, Schedule A: 20 mg
  2. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 40 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG001
    title
    Phase 1, Schedule A: 40 mg
  3. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 80 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG002
    title
    Phase 1, Schedule A: 80 mg
  4. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle.
    id
    OG003
    title
    Phase 1, Schedule A: 120 mg
  5. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG004
    title
    Phase 1, Schedule A: 180 mg
  6. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 270 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG005
    title
    Phase 1, Schedule A: 270 mg
  7. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 300 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG006
    title
    Phase 1, Schedule A: 300 mg
  8. description
    All participants in Phase I, Schedule A, who received NMS-03592088 at the starting dose of 360 mg administered orally once daily for 21 consecutive days followed by 7 days of rest in a 28-day cycle
    id
    OG007
    title
    Phase 1, Schedule A: 360 mg
  9. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 120 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
    id
    OG008
    title
    Phase 1, Schedule B: 120 mg
  10. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 180 mg administered orally once daily for 28 consecutive days, in a 28-day cycle.
    id
    OG009
    title
    Phase 1, Schedule B: 180 mg
  11. description
    All participants in Phase I, Schedule B, who received NMS-03592088 at the starting dose of 250 mg administered orally once daily for 28 consecutive days, in a 28-day cycle
    id
    OG010
    title
    Phase 1, Schedule B: 250 mg
  12. description
    NMS-03592088 was administered, on Cycle 1, at 360 mg/day (loading dose) for 5 consecutive days, followed by 150 mg/day (maintenance dose) for 23 consecutive days. The same maintenance dose (150 mg/day) was administered from Cycle 2 onwards.
    id
    OG011
    title
    Phase 2, Schedule B:360+150 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Treated patient population: The treated patient population consists of all enrolled participants who actually receive at least one treatment administration. This population was evaluated in the analysis of patient disposition, baseline characteristics, treatment exposure, efficacy and safety.
reporting Status
POSTED
time Frame
Adverse events were collected from screening visit and assessed up to 18 months
title
Treatment-emergent Adverse Events (TEAEs) Graded by National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0 Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice