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NCT02603172 · OUTCOME

Part A: Mean Change From Baseline in Blood Pressure (BP)

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
MEAN
Unit
Millimeter of mercury
Interval / dispersion
Standard Deviation
Time frame
Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose

What was measured

Systolic BP and diastolic BP were measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.

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

Diastolic BP: 15 minutes
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-0.63.11Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-0.43.86Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg3.54.86Not reportedNot reportedNot reported
Diastolic BP: 30 minutes
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-0.11.54Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.13.72Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg2.94.04Not reportedNot reportedNot reported
Diastolic BP: 1 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.04.13Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-1.13.53Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0.94.25Not reportedNot reportedNot reported
Diastolic BP: 2 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-3.13.16Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-1.74.95Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg1.44.06Not reportedNot reportedNot reported
Diastolic BP: 4 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-7.32.45Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-6.55.83Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg-2.56.54Not reportedNot reportedNot reported
Diastolic BP: 6 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-4.73.82Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-4.84.80Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg-0.34.38Not reportedNot reportedNot reported
Diastolic BP: 8 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.05.47Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-1.96.16Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0.86.09Not reportedNot reportedNot reported
Diastolic BP: 12 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-7.12.88Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-4.65.77Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg-2.67.39Not reportedNot reportedNot reported
Diastolic BP: 24 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-1.64.48Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-2.65.52Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg2.54.25Not reportedNot reportedNot reported
Diastolic BP: 48 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-3.02.69Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-2.16.35Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0.06.24Not reportedNot reportedNot reported
Diastolic BP: 72 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-4.73.82Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-3.25.54Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg-0.03.99Not reportedNot reportedNot reported
Systolic BP: 15 minutes
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.05.08Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.84.74Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg1.04.12Not reportedNot reportedNot reported
Systolic BP: 30 minutes
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-0.74.46Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-0.84.59Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg1.71.86Not reportedNot reportedNot reported
Systolic BP: 1 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-1.25.79Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.23.85Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg0.72.40Not reportedNot reportedNot reported
Systolic BP: 2 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.65.38Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.75.77Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg1.84.87Not reportedNot reportedNot reported
Systolic BP: 4 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-3.95.84Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.16.65Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg3.67.27Not reportedNot reportedNot reported
Systolic BP: 6 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.36.62Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg-1.15.91Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg1.26.09Not reportedNot reportedNot reported
Systolic BP: 8 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.09.37Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg1.58.50Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg3.87.62Not reportedNot reportedNot reported
Systolic BP: 12 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-3.25.70Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.17.54Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg3.67.72Not reportedNot reportedNot reported
Systolic BP: 24 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.85.06Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.15.64Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg4.36.75Not reportedNot reportedNot reported
Systolic BP: 48 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-2.24.83Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg0.54.88Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg3.37.55Not reportedNot reportedNot reported
Systolic BP: 72 hour
Values in Millimeter of mercury · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part A: GSK3039294 200 mg-1.17.84Not reportedNot reportedNot reported
Part A: GSK3039294 600 mg3.46.58Not reportedNot reportedNot reported
Part A: GSK3039294 1200 mg6.05.42Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.11
        value
        -0.6
      2. group Id
        OG001
        spread
        3.86
        value
        -0.4
      3. group Id
        OG002
        spread
        4.86
        value
        3.5
    title
    Diastolic BP: 15 minutes
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.54
        value
        -0.1
      2. group Id
        OG001
        spread
        3.72
        value
        0.1
      3. group Id
        OG002
        spread
        4.04
        value
        2.9
    title
    Diastolic BP: 30 minutes
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.13
        value
        -2.0
      2. group Id
        OG001
        spread
        3.53
        value
        -1.1
      3. group Id
        OG002
        spread
        4.25
        value
        0.9
    title
    Diastolic BP: 1 hour
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.16
        value
        -3.1
      2. group Id
        OG001
        spread
        4.95
        value
        -1.7
      3. group Id
        OG002
        spread
        4.06
        value
        1.4
    title
    Diastolic BP: 2 hour
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.45
        value
        -7.3
      2. group Id
        OG001
        spread
        5.83
        value
        -6.5
      3. group Id
        OG002
        spread
        6.54
        value
        -2.5
    title
    Diastolic BP: 4 hour
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.82
        value
        -4.7
      2. group Id
        OG001
        spread
        4.80
        value
        -4.8
      3. group Id
        OG002
        spread
        4.38
        value
        -0.3
    title
    Diastolic BP: 6 hour
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.47
        value
        -2.0
      2. group Id
        OG001
        spread
        6.16
        value
        -1.9
      3. group Id
        OG002
        spread
        6.09
        value
        0.8
    title
    Diastolic BP: 8 hour
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.88
        value
        -7.1
      2. group Id
        OG001
        spread
        5.77
        value
        -4.6
      3. group Id
        OG002
        spread
        7.39
        value
        -2.6
    title
    Diastolic BP: 12 hour
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.48
        value
        -1.6
      2. group Id
        OG001
        spread
        5.52
        value
        -2.6
      3. group Id
        OG002
        spread
        4.25
        value
        2.5
    title
    Diastolic BP: 24 hour
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.69
        value
        -3.0
      2. group Id
        OG001
        spread
        6.35
        value
        -2.1
      3. group Id
        OG002
        spread
        6.24
        value
        0.0
    title
    Diastolic BP: 48 hour
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.82
        value
        -4.7
      2. group Id
        OG001
        spread
        5.54
        value
        -3.2
      3. group Id
        OG002
        spread
        3.99
        value
        -0.0
    title
    Diastolic BP: 72 hour
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.08
        value
        -2.0
      2. group Id
        OG001
        spread
        4.74
        value
        0.8
      3. group Id
        OG002
        spread
        4.12
        value
        1.0
    title
    Systolic BP: 15 minutes
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      16
    3. group Id
      OG002
      value
      8
    units
    Participants
description
Systolic BP and diastolic BP were measured in semi-supine position after 5 min rest for the participants at indicated time points. Baseline is defined as the latest available assessment pre the first dose of study drug within each period in Part A. Change from Baseline was calculated as any visit post Baseline value minus Baseline value.
dispersion Type
Standard Deviation
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
MEAN
population Description
Safety population.
reporting Status
POSTED
time Frame
Baseline (pre-dose) and 15, 30 minutes, 1, 2, 4, 6, 8, 12, 24, 48 and 72 hours post-dose
title
Part A: Mean Change From Baseline in Blood Pressure (BP)
type
PRIMARY
unit Of Measure
Millimeter of mercury

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Preserved source evidence · Not medical advice