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NCT04985604 · OUTCOME

Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline

Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors · Source last updated 2025-10-02

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
Baseline and up to 23 months

What was measured

Blood samples were collected for the analysis of following chemistry parameters: creatine phosphokinase (CPK) increased, hypokalemia, hypoalbuminemia, hypercalcemia, hypocalcemia and hyponatremia. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to CTCAE version 5.

Analysis population: Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.

Groups in this outcome

Melanoma Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).

Tissue Agnostic Cohort

Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.

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

Analysis denominator · Participants

GroupSource count
Melanoma Cohort8
Tissue Agnostic Cohort15

Reported measurements

CPK increased, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort2Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort4Not reportedNot reportedNot reportedNot reported
CPK increased, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort1Not reportedNot reportedNot reportedNot reported
CPK increased, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort1Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort1Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort2Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypokalemia, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort1Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort5Not reportedNot reportedNot reportedNot reported
Hypokalemia, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort1Not reportedNot reportedNot reportedNot reported
Hypokalemia, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hyponatremia, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort1Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort1Not reportedNot reportedNot reportedNot reported
Hyponatremia, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hyponatremia, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort1Not reportedNot reportedNot reportedNot reported
Hypercalcemia, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increased to Grade 2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort1Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increased to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Hypocalcemia, Increased to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melanoma Cohort0Not reportedNot reportedNot reportedNot reported
Tissue Agnostic Cohort0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    CPK increased, Increased to Grade 2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    CPK increased, Increased to Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    CPK increased, Increased to Grade 4
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Hypoalbuminemia, Increased to Grade 2
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hypoalbuminemia, Increased to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hypoalbuminemia, Increased to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
    title
    Hypokalemia, Increased to Grade 2
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Hypokalemia, Increased to Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hypokalemia, Increased to Grade 4
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Hyponatremia, Increased to Grade 2
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hyponatremia, Increased to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Hyponatremia, Increased to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      15
    units
    Participants
description
Blood samples were collected for the analysis of following chemistry parameters: creatine phosphokinase (CPK) increased, hypokalemia, hypoalbuminemia, hypercalcemia, hypocalcemia and hyponatremia. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe; Grade 4 (G4) life-threatening or disabling. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Any worst-case post baseline increase to G2, G3, and G4 are presented. The laboratory parameters were graded according to CTCAE version 5.
groups
  1. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg orally (PO) once weekly (QW).
    id
    OG000
    title
    Melanoma Cohort
  2. description
    Adult participants (≥ 18 years) were administered Tovorafenib 600 mg PO QW.
    id
    OG001
    title
    Tissue Agnostic Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Analysis Set comprises of all patients enrolled in the study who receive at least one dose of study drug.
reporting Status
POSTED
time Frame
Baseline and up to 23 months
title
Number of Participants With Worst Case Chemistry Results by Maximum Grade Increase Post-baseline Relative to Baseline
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice