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NCT02064387 · OUTCOME

Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (NHL)

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 Protein. 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 Protein excretion (24 hour) is presented.

Analysis population: Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed.

Groups in this outcome

Part 2: GSK2857916 3.40 mg/kg (NHL)

Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 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 2: GSK2857916 3.40 mg/kg (NHL)2

Reported measurements

Source class 1
Values in Grams per day · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Part 2: GSK2857916 3.40 mg/kg (NHL)0.00.18Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.18
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Urine samples were collected to assess urine Protein. 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 Protein excretion (24 hour) is presented.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days).
    id
    OG000
    title
    Part 2: GSK2857916 3.40 mg/kg (NHL)
param Type
MEAN
population Description
Part 2 NHL 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 2 (NHL)
type
PRIMARY
unit Of Measure
Grams per day

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

Preserved source evidence · Not medical advice