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NCT02780804 · OUTCOME

Frequency of Adverse Events for Entinostat

Entinostat in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors · Source last updated 2023-10-17

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
Up to 28 days

What was measured

The frequency of patients with at least one Grade 3 or greater adverse event that are at least possibly attributable to entinostat during cycle 1 will be summarized by study part, dose level.

Analysis population: All eligible enrolled patients.

Groups in this outcome

Stratum 1 With 3 mg/m²

Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2

Stratum 1 With 4 mg/m²

Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2

PK Part With 4 mg/m²

Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)

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

Analysis denominator · Participants

GroupSource count
Stratum 1 With 3 mg/m²6
Stratum 1 With 4 mg/m²9
PK Part With 4 mg/m²6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 With 3 mg/m²5Not reportedNot reportedNot reportedNot reported
Stratum 1 With 4 mg/m²7Not reportedNot reportedNot reportedNot reported
PK Part With 4 mg/m²5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      6
    units
    Participants
description
The frequency of patients with at least one Grade 3 or greater adverse event that are at least possibly attributable to entinostat during cycle 1 will be summarized by study part, dose level.
groups
  1. description
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 3 mg/m2
    id
    OG000
    title
    Stratum 1 With 3 mg/m²
  2. description
    Patients with recurrent or refractory solid tumors, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at 4 mg/m2
    id
    OG001
    title
    Stratum 1 With 4 mg/m²
  3. description
    Patients with recurrent or refractory solid tumors without bone marrow involvement, including lymphoma and CSN tumors, treated once weekly with entinostat administered as a single-agent at the RP2D (4 mg/m2)
    id
    OG002
    title
    PK Part With 4 mg/m²
param Type
COUNT_OF_PARTICIPANTS
population Description
All eligible enrolled patients.
reporting Status
POSTED
time Frame
Up to 28 days
title
Frequency of Adverse Events for Entinostat
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice