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NCT02064387 · OUTCOME

Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg

Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916 · Source last updated 2020-08-11

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Grams per day
Interval / dispersion
Standard Deviation
Time frame
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, 14, 15, 16)

What was measured

Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented

Analysis population: Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.

Groups in this outcome

Part 1: GSK2857916 2.50 mg/kg

Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 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 1: GSK2857916 2.50 mg/kg8

Reported measurements

Day 1 (Cycle 2), n=4

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg4
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg0.81.54Not reportedNot reportedNot reported
Day 1 (Cycle 3), n=2

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg2
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.20.31Not reportedNot reportedNot reported
Day 1 (Cycle 4), n=2

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg2
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.20.38Not reportedNot reportedNot reported
Day 1 (Cycle 5), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg0.0NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 6), n=2

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg2
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.20.33Not reportedNot reportedNot reported
Day 1 (Cycle 7), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg0.2NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 8), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.5NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 10), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.4NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 12), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.5NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 13), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.5NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 14), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.4NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 15), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.5NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 16), n=1

Analysis denominator · Participants

GroupSource count
Part 1: GSK2857916 2.50 mg/kg1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 2.50 mg/kg-0.5NANot reportedNot reportedNA indicates that standard deviation could not be calculated for a single participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.54
        value
        0.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Day 1 (Cycle 2), n=4
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.31
        value
        -0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Day 1 (Cycle 3), n=2
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.38
        value
        -0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Day 1 (Cycle 4), n=2
  4. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        0.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 5), n=1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.33
        value
        -0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      units
      Participants
    title
    Day 1 (Cycle 6), n=2
  6. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        0.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 7), n=1
  7. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 8), n=1
  8. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 10), n=1
  9. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 12), n=1
  10. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 13), n=1
  11. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 14), n=1
  12. categories
    1. measurements
      1. comment
        NA indicates that standard deviation could not be calculated for a single participant.
        group Id
        OG000
        spread
        NA
        value
        -0.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Day 1 (Cycle 15), n=1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
dispersion Type
Standard Deviation
groups
  1. description
    Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    OG000
    title
    Part 1: GSK2857916 2.50 mg/kg
param Type
MEAN
population Description
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
reporting Status
POSTED
time Frame
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, 14, 15, 16)
title
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg
type
PRIMARY
unit Of Measure
Grams per day

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

Preserved source evidence · Not medical advice