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NCT02807272 · OUTCOME

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Tipifarnib in Subjects With Chronic Myelomonocytic Leukemia, Other MDS/MPN, and Acute Myeloid Leukemia · Source last updated 2024-07-17

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 approximately 3 years

What was measured

An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with it. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE severity was rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03.: grade 1(mild), grade 2(moderate), grade 3(severe), grade 4(life-threatening), grade 5(death). An AE was considered serious if resulted in any of the following: death, life-threatening, caused inpatient hospitalization or prolonged it, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or was an important medical event.

Analysis population: FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in statistical analysis plan (SAP).

Groups in this outcome

CMML

Participants with CMML were grouped by KRAS/NRAS mutational status (wild type \[WT\], mutation \[Mut\], missing) and given tipifarnib 1200mg twice daily (BID) for 7 days in alternating weeks (Days 1-7, 15-21) in 28-day cycles.

MDS/MPN

Participants with MDS/MPN were stratified by ratio of expression (high or low) between CXCR4 and CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib at a dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
CMML37
MDS/MPN7

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CMML37Not reportedNot reportedNot reportedNot reported
MDS/MPN7Not reportedNot reportedNot reportedNot reported
Any tipifarnib-related TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CMML37Not reportedNot reportedNot reportedNot reported
MDS/MPN6Not reportedNot reportedNot reportedNot reported
Any serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CMML23Not reportedNot reportedNot reportedNot reported
MDS/MPN1Not reportedNot reportedNot reportedNot reported
Any tipifarnib-related serious TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CMML13Not reportedNot reportedNot reportedNot reported
MDS/MPN1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        7
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        6
    title
    Any tipifarnib-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        1
    title
    Any serious TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        1
    title
    Any tipifarnib-related serious TEAE
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    2. group Id
      OG001
      value
      7
    units
    Participants
description
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with it. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AE severity was rated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03.: grade 1(mild), grade 2(moderate), grade 3(severe), grade 4(life-threatening), grade 5(death). An AE was considered serious if resulted in any of the following: death, life-threatening, caused inpatient hospitalization or prolonged it, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or was an important medical event.
groups
  1. description
    Participants with CMML were grouped by KRAS/NRAS mutational status (wild type \[WT\], mutation \[Mut\], missing) and given tipifarnib 1200mg twice daily (BID) for 7 days in alternating weeks (Days 1-7, 15-21) in 28-day cycles.
    id
    OG000
    title
    CMML
  2. description
    Participants with MDS/MPN were stratified by ratio of expression (high or low) between CXCR4 and CXCR2 (CXCR4/2 ratio) receptors to receive tipifarnib at a dose of 400 mg, orally, BID on Day 1 through 21 of each 28-day treatment cycle.
    id
    OG001
    title
    MDS/MPN
param Type
COUNT_OF_PARTICIPANTS
population Description
FAS: All enrolled participants who received at least one dose of tipifarnib. Data was pooled into CMML and MDS/MPN arms as pre-specified in statistical analysis plan (SAP).
reporting Status
POSTED
time Frame
Up to approximately 3 years
title
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice