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NCT03614728 · OUTCOME

Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs

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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 3 years and 2 months

What was measured

Number of participants with AEs leading to dose interruptions, dose reductions and treatment discontinuation due to AEs were planned to be assessed.

Analysis population: All Treated Population. Data was not collected as no participants were enrolled in Part 2.

Groups in this outcome

Part 2-Dose Escalation: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.

Part 2-Dose Expansion: GSK3326595+5-Azacitidine

Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 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 2-Dose Escalation: GSK3326595+5-Azacitidine0
Part 2-Dose Expansion: GSK3326595+5-Azacitidine0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Number of participants with AEs leading to dose interruptions, dose reductions and treatment discontinuation due to AEs were planned to be assessed.
groups
  1. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose escalation cohort during Part 2 of the study.
    id
    OG000
    title
    Part 2-Dose Escalation: GSK3326595+5-Azacitidine
  2. description
    Participants were planned to receive GSK3326595 in combination with 5-Azacitidine in dose expansion cohort during Part 2 of the study.
    id
    OG001
    title
    Part 2-Dose Expansion: GSK3326595+5-Azacitidine
population Description
All Treated Population. Data was not collected as no participants were enrolled in Part 2.
reporting Status
POSTED
time Frame
Up to 3 years and 2 months
title
Part 2: Number of Participants With AEs Leading to Dose Interruptions, Dose Reductions and Treatment Discontinuation Due to AEs
type
PRIMARY

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

Preserved source evidence · Not medical advice