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NCT02603172 · OUTCOME

Part B: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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cohort 3: Up to Day 21; Cohort 4: Up to Day 35

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.

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 Cohort 4a and 4b were not recruited in Part B.

Groups in this outcome

Part B: Cohort 3- GSK3039294 600 mg QD

Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.

Part B: Cohort 4a- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).

Part B: Cohort 4b- GSK3039294

Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).

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 B: Cohort 3- GSK3039294 600 mg QD8
Part B: Cohort 4a- GSK30392940
Part B: Cohort 4b- GSK30392940

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD7Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      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.
groups
  1. description
    Participants received GSK3039294 600 mg, capsules, orally, under fed condition, QD for 7 days in cohort 3.
    id
    OG000
    title
    Part B: Cohort 3- GSK3039294 600 mg QD
  2. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4a. The dose level was to be adjusted once during the 21 days. Cohort 4a was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    OG001
    title
    Part B: Cohort 4a- GSK3039294
  3. description
    Participants were planned to receive repeat dose of GSK3039294 for 21 days in cohort 4b. The dose level was to be adjusted once during the 21 days. Cohort 4b was not initiated due to safety reasons during conduct of Part B (Cohort 3).
    id
    OG002
    title
    Part B: Cohort 4b- GSK3039294
param Type
COUNT_OF_PARTICIPANTS
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 Cohort 4a and 4b were not recruited in Part B.
reporting Status
POSTED
time Frame
Cohort 3: Up to Day 21; Cohort 4: Up to Day 35
title
Part B:Number of Participants With AEs and SAEs
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice