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NCT02603172 · OUTCOME

Part A: Number of Participants With Emergent Hematology 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
Day 1

What was measured

PCI ranges for the hematology parameters were as follows: white blood cell (WBC) count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of red blood cell \[RBC\] in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L).

Analysis population: Safety population

Groups in this outcome

Part A: GSK3039294 200 mg

Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.

Part A: GSK3039294 600 mg

Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.

Part A: GSK3039294 1200 mg

Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.

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 A: GSK3039294 200 mg8
Part A: GSK3039294 600 mg16
Part A: GSK3039294 1200 mg8

Reported measurements

Hematocrit: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Hematocrit: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Hemoglobin: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Hemoglobin: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Leukocytes: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Leukocytes: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Lymphocytes: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Lymphocytes: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Neutrophils: low
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Neutrophils: high
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 600 mg0Not reportedNot reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hematocrit: low
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hematocrit: high
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hemoglobin: low
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hemoglobin: high
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Leukocytes: low
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Leukocytes: high
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Lymphocytes: low
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Lymphocytes: high
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Neutrophils: low
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Neutrophils: high
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      8
    units
    Participants
description
PCI ranges for the hematology parameters were as follows: white blood cell (WBC) count (low: \<0.67 10\^9 cells/L and high: \>1.82 10\^9 cells/L), neutrophil count (low: \<0.83 10\^9 cells/L), hemoglobin (high: \>1.03 g/L in male, \>1.13 g/L in female), hemocrit (high: \>1.02 proportion of red blood cell \[RBC\] in blood for male, \>1.17 proportion of RBC in blood for female), platelet count (low: \<0.67 10\^9 cells/L and high: 1.57 10\^9 cells/L), and lymphocytes (low: \<0.81 10\^9 cells/L).
groups
  1. description
    Participants received a single dose of GSK3039294 (dose level 1) 200 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1.
    id
    OG000
    title
    Part A: GSK3039294 200 mg
  2. description
    Participants received a single dose of GSK3039294 (dose level 2) 600 mg capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 1. The remaining participants received the same dose of GSK3039294 (dose level 3) 600 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2. A washout period was maintained from Day 5 to 14 between two treatment cohorts.
    id
    OG001
    title
    Part A: GSK3039294 600 mg
  3. description
    Participants received a single dose of GSK3039294 (dose level 4) 1200 mg, capsules, orally, once on Day 1 and stayed in-house until Day 4 in cohort 2.
    id
    OG002
    title
    Part A: GSK3039294 1200 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population
reporting Status
POSTED
time Frame
Day 1
title
Part A: Number of Participants With Emergent Hematology by PCI Criteria
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice