Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02064387 · OUTCOME

Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 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)

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.

Groups in this outcome

Part 1: GSK2857916 0.12 mg/kg

Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.03 mg/kg

Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (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 0.12 mg/kg3
Part 1: GSK2857916 0.03 mg/kg0

Reported measurements

Source class 1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 1: GSK2857916 0.12 mg/kg0.40.72Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.72
        value
        0.4
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      0
    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 0.12 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 0.12 mg/kg
  2. description
    Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
    id
    OG001
    title
    Part 1: GSK2857916 0.03 mg/kg
param Type
MEAN
population Description
Part 1 Population. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Baseline and Day 1 (Cycle 2)
title
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 mg/kg
type
PRIMARY
unit Of Measure
Grams per day

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

Preserved source evidence · Not medical advice