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NCT01943851 · OUTCOME

Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs

A Dose Escalation Study to Investigate the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD) and Clinical Activity of GSK525762 in Subjects With Relapsed, Refractory Hematologic Malignancies · Source last updated 2024-10-01

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 36.4 weeks

What was measured

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.

Analysis population: All Treated Population.

Groups in this outcome

Part 2: GSK525762 60 mg QD CTCL

Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.

Part 2: GSK525762 75 mg QD MDS

Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762

Part 2: GSK525762 80 mg QD CTCL

Participants CTCL were administered once daily oral dose of 80 mg GSK525762

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

Analysis denominator · Participants

GroupSource count
Part 2: GSK525762 60 mg QD CTCL7
Part 2: GSK525762 75 mg QD MDS16
Part 2: GSK525762 80 mg QD CTCL1

Reported measurements

Non-serious AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL7Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS16Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL1Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL5Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS12Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL1Not reportedNot reportedNot reportedNot reported
AELD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS9Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        1
    title
    Non-serious AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        1
    title
    SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        0
    title
    AELD
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      1
    units
    Participants
description
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and SAE is defined as any untoward medical occurrence that, at any dose which results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or, is a congenital anomaly/birth defect. AELD is adverse events leading to permanent discontinuation of study treatment.
groups
  1. description
    Participants Cutaneous T cell lymphoma (CTCL) were administered once daily oral dose of 60 mg GSK525762.
    id
    OG000
    title
    Part 2: GSK525762 60 mg QD CTCL
  2. description
    Participants with Myelodysplastic Syndrome (MDS) were administered once daily oral dose of 75 mg GSK525762
    id
    OG001
    title
    Part 2: GSK525762 75 mg QD MDS
  3. description
    Participants CTCL were administered once daily oral dose of 80 mg GSK525762
    id
    OG002
    title
    Part 2: GSK525762 80 mg QD CTCL
param Type
COUNT_OF_PARTICIPANTS
population Description
All Treated Population.
reporting Status
POSTED
time Frame
Up to 36.4 weeks
title
Part 2: Number of Participants With Non-serious AEs and SAEs and AELDs
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice