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NCT01943851 · OUTCOME

Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method

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

Urine samples were collected to assess glucose, ketones, occult blood, urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.

Analysis population: All Treated Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).

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 MDS12
Part 2: GSK525762 80 mg QD CTCL1

Reported measurements

Glucose, n=5,12,1

Analysis denominator · Participants

GroupSource count
Part 2: GSK525762 60 mg QD CTCL5
Part 2: GSK525762 75 mg QD MDS12
Part 2: GSK525762 80 mg QD CTCL1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL4Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS3Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Ketones, n=7,12,1

Analysis denominator · Participants

GroupSource count
Part 2: GSK525762 60 mg QD CTCL7
Part 2: GSK525762 75 mg QD MDS12
Part 2: GSK525762 80 mg QD CTCL1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL1Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS0Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Occult blood, n=7,8,1

Analysis denominator · Participants

GroupSource count
Part 2: GSK525762 60 mg QD CTCL7
Part 2: GSK525762 75 mg QD MDS8
Part 2: GSK525762 80 mg QD CTCL1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL2Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 75 mg QD MDS2Not reportedNot reportedNot reportedNot reported
Part 2: GSK525762 80 mg QD CTCL0Not reportedNot reportedNot reportedNot reported
Protein, n=6,11,1

Analysis denominator · Participants

GroupSource count
Part 2: GSK525762 60 mg QD CTCL6
Part 2: GSK525762 75 mg QD MDS11
Part 2: GSK525762 80 mg QD CTCL1
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 MDS7Not 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
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Glucose, n=5,12,1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Ketones, n=7,12,1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Occult blood, n=7,8,1
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Protein, n=6,11,1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Urine samples were collected to assess glucose, ketones, occult blood, urine protein. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Any increase was defined as any increase in proportional concentrations relative to Baseline. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post Baseline with any increase is presented.
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. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles).
reporting Status
POSTED
time Frame
Up to 36.4 weeks
title
Part 2: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice