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NCT04146038 · OUTCOME

Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine

Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease · Source last updated 2023-05-24

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
During the first 2 cycles, 56 days total

What was measured

Study drug associated adverse events during therapy

Groups in this outcome

Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)

CYCLE 1: Patients receive salsalate PO BID until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine IV for 10 days or azacitidine IV for 7 days. Starting 24 hour after salsalate, patients also receive venetoclax PO continuously until completion of cycle 1. CYCLE 2: Patients receive decitabine IV for 5 days or azacitidine IV for 7 days, salsalate PO BID, and venetoclax PO continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV Decitabine: Given IV Salsalate: Given PO Venetoclax: Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Study drug associated adverse events during therapy
groups
  1. description
    CYCLE 1: Patients receive salsalate PO BID until completion of cycle 1. 24-48 hours later or concurrent with salsalate, patients begin to receive decitabine IV for 10 days or azacitidine IV for 7 days. Starting 24 hour after salsalate, patients also receive venetoclax PO continuously until completion of cycle 1. CYCLE 2: Patients receive decitabine IV for 5 days or azacitidine IV for 7 days, salsalate PO BID, and venetoclax PO continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given IV Decitabine: Given IV Salsalate: Given PO Venetoclax: Given PO
    id
    OG000
    title
    Treatment (Salsalate, Decitabine, Azacitidine, Venetoclax)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
During the first 2 cycles, 56 days total
title
Number of Participants Experiencing Adverse Events Incidence With of Salicylate + Venetoclax + Decitabine
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice