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NCT02603172 · OUTCOME

Part C: Number of Participants With AEs and SAEs

A Safety Study of GSK3039294 in Healthy Volunteers and Patients With Systemic Amyloidosis · Source last updated 2019-09-23

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 Day 63

What was measured

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. This analysis was planned but not performed for Part C as the study was terminated early during Part B.

Analysis population: Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.

Groups in this outcome

Part C: GSK3039294

Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.

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 C: GSK30392940

Reported measurements

Any AEs
Any SAEs
Complete source fields
classes
  1. title
    Any AEs
  2. title
    Any SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other important medical events judged by the investigator that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention. This analysis was planned but not performed for Part C as the study was terminated early during Part B.
groups
  1. description
    Participants were planned to receive repeat dosing of GSK3039294 at the predicted optimal clinical dose determined from Part B for a total of 21 days.
    id
    OG000
    title
    Part C: GSK3039294
population Description
Safety Population. Data was not collected as study was terminated due to safety reasons during conduct of Part B (end of Cohort 3) whereas Part C was not initiated.
reporting Status
POSTED
time Frame
Up to Day 63
title
Part C: Number of Participants With AEs and SAEs
type
PRIMARY

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

Preserved source evidence · Not medical advice