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NCT01943851 · OUTCOME

Part 1: 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 86.9 weeks

What was measured

Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). 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 1: GSK525762 5 mg QD

Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.

Part 1: GSK525762 10 mg QD

Participants were administered once daily oral dose of 10 mg GSK525762.

Part 1: GSK525762 20 mg QD

Participants were administered once daily oral dose of 20 mg GSK525762.

Part 1: GSK525762 30 mg QD MM

Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.

Part 1: GSK525762 40 mg QD

Participants were administered once daily oral dose of 40 mg GSK525762.

Part 1: GSK525762 40 mg QD MM

Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.

Part 1: GSK525762 60 mg QD AML

Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.

Part 1: GSK525762 60 mg QD NHL

Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.

Part 1: GSK525762 60 mg QD MM

Participants with MM were administered once daily oral dose of 60 mg GSK525762.

Part 1: GSK525762 75 mg QD AML

Participants with AML were administered once daily oral dose of 75 mg GSK525762.

Part 1: GSK525762 80 mg QD

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

Part 1: GSK525762 80 mg QD AML

Participants with AML were administered once daily oral dose of 80 mg GSK525762.

Part 1: GSK525762 80 mg QD NHL

Participants with NHL were administered once daily oral dose of 80 mg GSK525762.

Part 1: GSK525762 100 mg QD AML

Participants with AML were administered once daily oral dose of 100 mg GSK525762.

Part 1: GSK525762 120 mg QD AML

Participants with AML were administered once daily oral dose of 120 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 1: GSK525762 5 mg QD1
Part 1: GSK525762 10 mg QD1
Part 1: GSK525762 20 mg QD1
Part 1: GSK525762 30 mg QD MM4
Part 1: GSK525762 40 mg QD1
Part 1: GSK525762 40 mg QD MM4
Part 1: GSK525762 60 mg QD AML5
Part 1: GSK525762 60 mg QD NHL15
Part 1: GSK525762 60 mg QD MM3
Part 1: GSK525762 75 mg QD AML7
Part 1: GSK525762 80 mg QD1
Part 1: GSK525762 80 mg QD AML6
Part 1: GSK525762 80 mg QD NHL5
Part 1: GSK525762 100 mg QD AML11
Part 1: GSK525762 120 mg QD AML2

Reported measurements

Glucose, n=1,1,1,4,1,4,4,15, 3,5,0,3,5,8,1

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 5 mg QD1
Part 1: GSK525762 10 mg QD1
Part 1: GSK525762 20 mg QD1
Part 1: GSK525762 30 mg QD MM4
Part 1: GSK525762 40 mg QD1
Part 1: GSK525762 40 mg QD MM4
Part 1: GSK525762 60 mg QD AML4
Part 1: GSK525762 60 mg QD NHL15
Part 1: GSK525762 60 mg QD MM3
Part 1: GSK525762 75 mg QD AML5
Part 1: GSK525762 80 mg QD0
Part 1: GSK525762 80 mg QD AML3
Part 1: GSK525762 80 mg QD NHL5
Part 1: GSK525762 100 mg QD AML8
Part 1: GSK525762 120 mg QD AML1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 5 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 10 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 20 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD MM1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD MM1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD AML1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD NHL0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 75 mg QD AML2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD AML0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD NHL2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD AML2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 120 mg QD AML1Not reportedNot reportedNot reportedNot reported
Ketones, n=1,1,1,4,1,4,4,13,3,5,1,6,5,11,2

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 5 mg QD1
Part 1: GSK525762 10 mg QD1
Part 1: GSK525762 20 mg QD1
Part 1: GSK525762 30 mg QD MM4
Part 1: GSK525762 40 mg QD1
Part 1: GSK525762 40 mg QD MM4
Part 1: GSK525762 60 mg QD AML4
Part 1: GSK525762 60 mg QD NHL13
Part 1: GSK525762 60 mg QD MM3
Part 1: GSK525762 75 mg QD AML5
Part 1: GSK525762 80 mg QD1
Part 1: GSK525762 80 mg QD AML6
Part 1: GSK525762 80 mg QD NHL5
Part 1: GSK525762 100 mg QD AML11
Part 1: GSK525762 120 mg QD AML2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 5 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 10 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 20 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD AML0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD NHL1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 75 mg QD AML2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD AML1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD NHL0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD AML3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 120 mg QD AML1Not reportedNot reportedNot reportedNot reported
Occult blood, n=1,1,1,4,1,4,5,14,3,7,1,6,5,11,2

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 5 mg QD1
Part 1: GSK525762 10 mg QD1
Part 1: GSK525762 20 mg QD1
Part 1: GSK525762 30 mg QD MM4
Part 1: GSK525762 40 mg QD1
Part 1: GSK525762 40 mg QD MM4
Part 1: GSK525762 60 mg QD AML5
Part 1: GSK525762 60 mg QD NHL14
Part 1: GSK525762 60 mg QD MM3
Part 1: GSK525762 75 mg QD AML7
Part 1: GSK525762 80 mg QD1
Part 1: GSK525762 80 mg QD AML6
Part 1: GSK525762 80 mg QD NHL5
Part 1: GSK525762 100 mg QD AML11
Part 1: GSK525762 120 mg QD AML2
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 5 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 10 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 20 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD MM3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD MM2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD AML3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD NHL4Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD MM3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 75 mg QD AML3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD AML4Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD NHL2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD AML4Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 120 mg QD AML1Not reportedNot reportedNot reportedNot reported
Protein, n=1,1,1,4,1,4,2,12,1,5,0,3,4,7,1

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 5 mg QD1
Part 1: GSK525762 10 mg QD1
Part 1: GSK525762 20 mg QD1
Part 1: GSK525762 30 mg QD MM4
Part 1: GSK525762 40 mg QD1
Part 1: GSK525762 40 mg QD MM4
Part 1: GSK525762 60 mg QD AML2
Part 1: GSK525762 60 mg QD NHL12
Part 1: GSK525762 60 mg QD MM1
Part 1: GSK525762 75 mg QD AML5
Part 1: GSK525762 80 mg QD0
Part 1: GSK525762 80 mg QD AML3
Part 1: GSK525762 80 mg QD NHL4
Part 1: GSK525762 100 mg QD AML7
Part 1: GSK525762 120 mg QD AML1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 5 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 10 mg QD0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 20 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 30 mg QD MM2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 40 mg QD MM2Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD AML1Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD NHL5Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 75 mg QD AML3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD AML0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 80 mg QD NHL3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 100 mg QD AML3Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 120 mg QD AML1Not reportedNot reportedNot reportedNot reported
Monoclonal pro, n=0,0,0,0,0,1,0,0,2,0,0,0,0,0,0

Analysis denominator · Participants

GroupSource count
Part 1: GSK525762 5 mg QD0
Part 1: GSK525762 10 mg QD0
Part 1: GSK525762 20 mg QD0
Part 1: GSK525762 30 mg QD MM0
Part 1: GSK525762 40 mg QD0
Part 1: GSK525762 40 mg QD MM1
Part 1: GSK525762 60 mg QD AML0
Part 1: GSK525762 60 mg QD NHL0
Part 1: GSK525762 60 mg QD MM2
Part 1: GSK525762 75 mg QD AML0
Part 1: GSK525762 80 mg QD0
Part 1: GSK525762 80 mg QD AML0
Part 1: GSK525762 80 mg QD NHL0
Part 1: GSK525762 100 mg QD AML0
Part 1: GSK525762 120 mg QD AML0
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 40 mg QD MM0Not reportedNot reportedNot reportedNot reported
Part 1: GSK525762 60 mg QD MM0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        2
      11. group Id
        OG011
        value
        0
      12. group Id
        OG012
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        15
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        3
      units
      Participants
    title
    Glucose, n=1,1,1,4,1,4,4,15, 3,5,0,3,5,8,1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        2
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        1
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        13
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    Ketones, n=1,1,1,4,1,4,4,13,3,5,1,6,5,11,2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        5
      8. group Id
        OG007
        value
        14
      9. group Id
        OG008
        value
        3
      10. group Id
        OG009
        value
        7
      11. group Id
        OG010
        value
        1
      12. group Id
        OG011
        value
        6
      units
      Participants
    title
    Occult blood, n=1,1,1,4,1,4,5,14,3,7,1,6,5,11,2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        1
      8. group Id
        OG007
        value
        5
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        3
      11. group Id
        OG011
        value
        0
      12. group Id
        OG012
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        2
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        5
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        3
      units
      Participants
    title
    Protein, n=1,1,1,4,1,4,2,12,1,5,0,3,4,7,1
  5. categories
    1. measurements
      1. group Id
        OG005
        value
        0
      2. group Id
        OG008
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        2
      10. group Id
        OG009
        value
        0
      11. group Id
        OG010
        value
        0
      12. group Id
        OG011
        value
        0
      units
      Participants
    title
    Monoclonal pro, n=0,0,0,0,0,1,0,0,2,0,0,0,0,0,0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      5
    8. group Id
      OG007
      value
      15
    9. group Id
      OG008
      value
      3
    10. group Id
      OG009
      value
      7
    11. group Id
      OG010
      value
      1
    12. group Id
      OG011
      value
      6
    units
    Participants
description
Urine samples were collected to assess glucose, ketones, occult blood, urine protein, and monoclonal protein (monoclonal pro). 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 were administered once daily oral dose of 5 milligrams (mg) GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 5 mg QD
  2. description
    Participants were administered once daily oral dose of 10 mg GSK525762.
    id
    OG001
    title
    Part 1: GSK525762 10 mg QD
  3. description
    Participants were administered once daily oral dose of 20 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 20 mg QD
  4. description
    Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
    id
    OG003
    title
    Part 1: GSK525762 30 mg QD MM
  5. description
    Participants were administered once daily oral dose of 40 mg GSK525762.
    id
    OG004
    title
    Part 1: GSK525762 40 mg QD
  6. description
    Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
    id
    OG005
    title
    Part 1: GSK525762 40 mg QD MM
  7. description
    Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
    id
    OG006
    title
    Part 1: GSK525762 60 mg QD AML
  8. description
    Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
    id
    OG007
    title
    Part 1: GSK525762 60 mg QD NHL
  9. description
    Participants with MM were administered once daily oral dose of 60 mg GSK525762.
    id
    OG008
    title
    Part 1: GSK525762 60 mg QD MM
  10. description
    Participants with AML were administered once daily oral dose of 75 mg GSK525762.
    id
    OG009
    title
    Part 1: GSK525762 75 mg QD AML
  11. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    OG010
    title
    Part 1: GSK525762 80 mg QD
  12. description
    Participants with AML were administered once daily oral dose of 80 mg GSK525762.
    id
    OG011
    title
    Part 1: GSK525762 80 mg QD AML
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 86.9 weeks
title
Part 1: Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice