Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01943851 · OUTCOME

Part 2: Number of Participants With Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)

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

12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.

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

Abnormal-Clinically significant
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 MDS1Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Abnormal-Not Clinically significant
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL6Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS11Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Abnormal-Clinically significant
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        1
    title
    Abnormal-Not Clinically significant
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      1
    units
    Participants
description
12-lead ECGs were recorded with the participants in a supine position using an ECG machine. Number of participants with worst-case clinically significant and not clinically significant abnormal ECG findings have been presented. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
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 Worst-case Post-Baseline Abnormal Electrocardiogram (ECG) Findings (Investigator Reading)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice