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NCT01943851 · OUTCOME

Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts)

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 36.4 weeks

What was measured

ORR4 for CTCL cohorts is defined as the percentage of participants that have achieved a CR or PR lasting at least 4 months per global response criteria and the modified severity weighted assessment tool (mSWAT). ORR4 and 95% exact confidence interval is presented.

Analysis population: All Treated Population.

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 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 80 mg QD CTCL1

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: GSK525762 60 mg QD CTCL0Not reported041Not reported
Part 2: GSK525762 80 mg QD CTCL0Not reported097.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        41
        value
        0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        97.5
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      1
    units
    Participants
description
ORR4 for CTCL cohorts is defined as the percentage of participants that have achieved a CR or PR lasting at least 4 months per global response criteria and the modified severity weighted assessment tool (mSWAT). ORR4 and 95% exact confidence interval is presented.
dispersion Type
95% Confidence Interval
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 CTCL were administered once daily oral dose of 80 mg GSK525762
    id
    OG001
    title
    Part 2: GSK525762 80 mg QD CTCL
param Type
NUMBER
population Description
All Treated Population.
reporting Status
POSTED
time Frame
Up to 36.4 weeks
title
Part 2: Objective Response Rate Lasting at Least 4 Months (ORR4) (CTCL Cohorts)
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice