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NCT01587703 · OUTCOME

Number of Participants With PSA50 Response Rate-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
NUMBER
Unit
Participants
Interval / dispersion
95% Confidence Interval
Time frame
Median of 1.41 months of drug exposure

What was measured

PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.

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 Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: GSK525762 20 mg BID0Not reportedNANAConfidence interval could not be calculated as there were no responders
Part 1: GSK525762 30 mg BID0Not reportedNANAConfidence interval could not be calculated as there were no responders
Part 1: GSK525762 40 mg BID0Not reportedNANAConfidence interval could not be calculated as there were no responders
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Confidence interval could not be calculated as there were no responders
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. comment
        Confidence interval could not be calculated as there were no responders
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      3. comment
        Confidence interval could not be calculated as there were no responders
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    units
    Participants
description
PSA 50 Response rate is defined as the response rate that a PSA reduction from Baseline \>=50% is observed at 12 weeks and beyond (must be confirmed by a second value). The number of participants with PSA \>=50% reduction is presented along with 95% confidence intervals.
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
NUMBER
population Description
All Treated Population
reporting Status
POSTED
time Frame
Median of 1.41 months of drug exposure
title
Number of Participants With PSA50 Response Rate-Part 1 BID
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice