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NCT01587703 · OUTCOME

Progression Free Survival-Part 1 QD

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Median of 1.38 months of drug exposure

What was measured

Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.

Analysis population: All Treated Population

Groups in this outcome

Part 1: GSK525762 2 mg QD

Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.

Part 1: GSK525762 4 mg QD

Participants were administered once daily oral dose of 4 mg GSK525762

Part 1: GSK525762 8 mg QD

Participants were administered once daily oral dose of 8 mg GSK525762.

Part 1: GSK525762 16 mg QD

Participants were administered once daily oral dose of 16 mg GSK525762.

Part 1: GSK525762 30 mg QD

Participants were administered once daily oral dose of 30 mg GSK525762.

Part 1: GSK525762 60 mg QD

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

Part 1: GSK525762 80 mg QD

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

Part 1: GSK525762 100 mg QD

Participants were administered once daily oral dose of 100 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 2 mg QD3
Part 1: GSK525762 4 mg QD4
Part 1: GSK525762 8 mg QD1
Part 1: GSK525762 16 mg QD3
Part 1: GSK525762 30 mg QD4
Part 1: GSK525762 60 mg QD9
Part 1: GSK525762 80 mg QD32
Part 1: GSK525762 100 mg QD9

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 2 mg QD0.3Not reported0.30.4Not reported
Part 1: GSK525762 4 mg QD4.1Not reported0.913.9Not reported
Part 1: GSK525762 8 mg QD2.2Not reportedNANAConfidence interval could not be calculated as only one participant was analyzed
Part 1: GSK525762 16 mg QD9.1Not reported1.413.9Not reported
Part 1: GSK525762 30 mg QD3.8Not reported0.95.4Not reported
Part 1: GSK525762 60 mg QD3.6Not reported1.48.9Not reported
Part 1: GSK525762 80 mg QD6.5Not reported2.69.1Not reported
Part 1: GSK525762 100 mg QD7.5Not reported6.018.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        0.4
        value
        0.3
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        13.9
        value
        4.1
      3. comment
        Confidence interval could not be calculated as only one participant was analyzed
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        2.2
      4. group Id
        OG003
        lower Limit
        1.4
        upper Limit
        13.9
        value
        9.1
      5. group Id
        OG004
        lower Limit
        0.9
        upper Limit
        5.4
        value
        3.8
      6. group Id
        OG005
        lower Limit
        1.4
        upper Limit
        8.9
        value
        3.6
      7. group Id
        OG006
        lower Limit
        2.6
        upper Limit
        9.1
        value
        6.5
      8. group Id
        OG007
        lower Limit
        6.0
        upper Limit
        18.0
        value
        7.5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      9
    7. group Id
      OG006
      value
      32
    8. group Id
      OG007
      value
      9
    units
    Participants
description
Progression free survival is defined as the interval of time (in months) between the date of first dose and the earlier of the date of disease progression and date of death due to any cause. Confidence intervals were estimated using Brookmeyer Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 2 mg QD
  2. description
    Participants were administered once daily oral dose of 4 mg GSK525762
    id
    OG001
    title
    Part 1: GSK525762 4 mg QD
  3. description
    Participants were administered once daily oral dose of 8 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 8 mg QD
  4. description
    Participants were administered once daily oral dose of 16 mg GSK525762.
    id
    OG003
    title
    Part 1: GSK525762 16 mg QD
  5. description
    Participants were administered once daily oral dose of 30 mg GSK525762.
    id
    OG004
    title
    Part 1: GSK525762 30 mg QD
  6. description
    Participants were administered once daily oral dose of 60 mg GSK525762.
    id
    OG005
    title
    Part 1: GSK525762 60 mg QD
  7. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    OG006
    title
    Part 1: GSK525762 80 mg QD
  8. description
    Participants were administered once daily oral dose of 100 mg GSK525762.
    id
    OG007
    title
    Part 1: GSK525762 100 mg QD
param Type
MEDIAN
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.38 months of drug exposure
title
Progression Free Survival-Part 1 QD
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice