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NCT02603172 · OUTCOME

Part B: Number of Participants With Emergent Clinical Chemistry by PCI Criteria

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 and 4: Up to Day 3

What was measured

PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<0.86 g/L), calcium (low: \<0.91 mmol/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total CO2 (low: \<0.86 mmol/L and high: \>1.14 mmol/L).

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

Albumin: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Albumin: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Calcium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Calcium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Glucose: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Glucose: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Potassium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Potassium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Sodium: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Sodium: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B: Cohort 3- GSK3039294 600 mg QD0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Albumin: low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Albumin: high
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Calcium: low
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Calcium: high
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Glucose: low
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Glucose: high
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Potassium: low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Potassium: high
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Sodium: low
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Sodium: high
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    units
    Participants
description
PCI ranges for the clinical chemistry parameters were as follows: albumin (low: \<0.86 g/L), calcium (low: \<0.91 mmol/L and high: \>1.06 mmol/L), glucose (low: \<0.71 mmol/L and high: \>1.41 mmol/L), magnesium (low: \<0.63 mmol/L and high: \>1.03 mmol/L), phosphorous (low: \<0.80 mmol/L and high: \>1.14 mmol/L), potassium (low: \<0.86 mmol/L and high: \>1.10 mmol/L), sodium (low: \<0.96 mmol/L and high: \>1.03 mmol/L), and total CO2 (low: \<0.86 mmol/L and high: \>1.14 mmol/L).
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 and 4: Up to Day 3
title
Part B: Number of Participants With Emergent Clinical Chemistry by PCI Criteria
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice