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NCT01587703 · OUTCOME

Overall Survival-Part 1 BID

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 1.41 months of drug exposure

What was measured

Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.

Analysis population: All Treated Population

Groups in this outcome

Part 1: GSK525762 20 mg BID

Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.

Part 1: GSK525762 30 mg BID

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

Part 1: GSK525762 40 mg BID

Participants were administered twice daily oral dose of 40 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 20 mg BID4
Part 1: GSK525762 30 mg BID10
Part 1: GSK525762 40 mg BID5

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BIDNANot reported14.5NAValues could not be estimated due to limited amount of observed follow-up time.
Part 1: GSK525762 30 mg BID6.0Not reported2.912.2Not reported
Part 1: GSK525762 40 mg BID13.3Not reported7.918.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Values could not be estimated due to limited amount of observed follow-up time.
        group Id
        OG000
        lower Limit
        14.5
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        2.9
        upper Limit
        12.2
        value
        6.0
      3. group Id
        OG002
        lower Limit
        7.9
        upper Limit
        18.7
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Overall survival is defined as the interval of time (in months) between the date of first dose and the date of death due to any cause. The median overall survival is presented along with 95% confidence interval. Confidence intervals were estimated using Brookmeyer Crowley method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
    id
    OG000
    title
    Part 1: GSK525762 20 mg BID
  2. description
    Participants were administered twice daily oral dose of 30 mg GSK525762.
    id
    OG001
    title
    Part 1: GSK525762 30 mg BID
  3. description
    Participants were administered twice daily oral dose of 40 mg GSK525762.
    id
    OG002
    title
    Part 1: GSK525762 40 mg BID
param Type
MEDIAN
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Overall Survival-Part 1 BID
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice