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NCT03614728 · OUTCOME

Part 1: Overall Response Rate

Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) · Source last updated 2023-02-06

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 30.8 months

What was measured

Overall response rate is defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria, where CR=Bone marrow: \<=5% myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by \>=50% over pre-treatment but still \>5%; mCR= Bone marrow: ≤ 5% myeloblasts and decrease by \>=50% over pre-treatment. Percentage values are rounded off.

Analysis population: All Treated Population.

Groups in this outcome

Part 1: GSK3326595 400 mg

Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

Part 1: GSK3326595 300 mg

Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.

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: GSK3326595 400 mg13
Part 1: GSK3326595 300 mg17

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: GSK3326595 400 mg0Not reported0.024.7Not reported
Part 1: GSK3326595 300 mg6Not reported0.128.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        24.7
        value
        0
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        28.7
        value
        6
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      17
    units
    Participants
description
Overall response rate is defined as the percentage of participants achieving a CR, mCR, or PR, per IWG criteria, where CR=Bone marrow: \<=5% myeloblasts with normal maturation of all cell lines; PR=Bone marrow blasts decreased by \>=50% over pre-treatment but still \>5%; mCR= Bone marrow: ≤ 5% myeloblasts and decrease by \>=50% over pre-treatment. Percentage values are rounded off.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received GSK3326595 400 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
    id
    OG000
    title
    Part 1: GSK3326595 400 mg
  2. description
    Participants received GSK3326595 300 mg, tablets, orally, once daily until progression, unacceptable toxicity, or withdrawal of consent during Part 1 of the study.
    id
    OG001
    title
    Part 1: GSK3326595 300 mg
param Type
NUMBER
population Description
All Treated Population.
reporting Status
POSTED
time Frame
Up to 30.8 months
title
Part 1: Overall Response Rate
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice