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NCT04409639 · OUTCOME

Related Grade 3-5 Adverse Events

Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations · Source last updated 2026-07-21

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
From the start of study treatment to the last dose of study treatment, up to 20 months

What was measured

To assess the safety of Cobimetinib treatment in CMML. This outcome measure will report the count of patients who experienced a Grade 3, Grade 4, and Grade 5 treatment-related adverse reaction while on study treatment.

Groups in this outcome

HMA Refractory

Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.

Newly Diagnosed

Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.

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

Analysis denominator · Participants

GroupSource count
HMA Refractory5
Newly Diagnosed9

Reported measurements

Patients with a Related, Grade 3 Toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HMA Refractory1Not reportedNot reportedNot reportedNot reported
Newly Diagnosed6Not reportedNot reportedNot reportedNot reported
Patients with a Related, Grade 4 Toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HMA Refractory2Not reportedNot reportedNot reportedNot reported
Newly Diagnosed1Not reportedNot reportedNot reportedNot reported
Patients with a Related, Grade 5 Toxicity
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
HMA Refractory0Not reportedNot reportedNot reportedNot reported
Newly Diagnosed0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        6
    title
    Patients with a Related, Grade 3 Toxicity
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Patients with a Related, Grade 4 Toxicity
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Patients with a Related, Grade 5 Toxicity
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      9
    units
    Participants
description
To assess the safety of Cobimetinib treatment in CMML. This outcome measure will report the count of patients who experienced a Grade 3, Grade 4, and Grade 5 treatment-related adverse reaction while on study treatment.
groups
  1. description
    Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
    id
    OG000
    title
    HMA Refractory
  2. description
    Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation. Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
    id
    OG001
    title
    Newly Diagnosed
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
From the start of study treatment to the last dose of study treatment, up to 20 months
title
Related Grade 3-5 Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice