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NCT02064387 · OUTCOME

Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 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, 9, 10, 11, 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 3.40 mg/kg

Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 4.60 mg/kg

Participants were administered a dose of 4.60 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

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	3
Part 1: GSK2857916 4.60 mg/kg	6

Reported measurements

Day 1 (Cycle 2), n=2,5

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	5

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.83	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	0.0	0.45	Not reported	Not reported	Not reported

Day 1 (Cycle 3), n=2,4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	4

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.81	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	-0.0	0.23	Not reported	Not reported	Not reported

Day 1 (Cycle 4), n=2,4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	4

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.7	0.79	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	-0.1	0.25	Not reported	Not reported	Not reported

Day 1 (Cycle 5), n=2,4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	4

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.78	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	-0.1	0.46	Not reported	Not reported	Not reported

Day 1 (Cycle 6), n=2,4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	4

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.80	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	-0.0	0.33	Not reported	Not reported	Not reported

Day 1 (Cycle 7), n=2,4

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	4

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.79	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	-0.1	0.48	Not reported	Not reported	Not reported

Day 1 (Cycle 8), n=2,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	2
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-0.6	0.80	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	0.1	0.15	Not reported	Not reported	Not reported

Day 1 (Cycle 9), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.1	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.2	0.33	Not reported	Not reported	Not reported

Day 1 (Cycle 10), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.1	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	-0.0	0.03	Not reported	Not reported	Not reported

Day 1 (Cycle 11), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.2	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	-0.1	0.06	Not reported	Not reported	Not reported

Day 1 (Cycle 12), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.2	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.0	0.13	Not reported	Not reported	Not reported

Day 1 (Cycle 13), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.1	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.0	0.09	Not reported	Not reported	Not reported

Day 1 (Cycle 14), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.0	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.3	0.11	Not reported	Not reported	Not reported

Day 1 (Cycle 15), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.1	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.1	0.10	Not reported	Not reported	Not reported

Day 1 (Cycle 16), n=1,2

Analysis denominator · Participants

Group	Source count
Part 1: GSK2857916 3.40 mg/kg	1
Part 1: GSK2857916 4.60 mg/kg	2

Values in Grams per day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 3.40 mg/kg	-1.2	NA	Not reported	Not reported	NA indicates that standard deviation could not be calculated for a single participant.
Part 1: GSK2857916 4.60 mg/kg	0.4	0.11	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.83
value
-0.6
group Id
OG001
spread
0.45
value
0.0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
5
units
Participants
title
Day 1 (Cycle 2), n=2,5
categories
measurements
group Id
OG000
spread
0.81
value
-0.6
group Id
OG001
spread
0.23
value
-0.0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
units
Participants
title
Day 1 (Cycle 3), n=2,4
categories
measurements
group Id
OG000
spread
0.79
value
-0.7
group Id
OG001
spread
0.25
value
-0.1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
units
Participants
title
Day 1 (Cycle 4), n=2,4
categories
measurements
group Id
OG000
spread
0.78
value
-0.6
group Id
OG001
spread
0.46
value
-0.1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
units
Participants
title
Day 1 (Cycle 5), n=2,4
categories
measurements
group Id
OG000
spread
0.80
value
-0.6
group Id
OG001
spread
0.33
value
-0.0
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
units
Participants
title
Day 1 (Cycle 6), n=2,4
categories
measurements
group Id
OG000
spread
0.79
value
-0.6
group Id
OG001
spread
0.48
value
-0.1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
4
units
Participants
title
Day 1 (Cycle 7), n=2,4
categories
measurements
group Id
OG000
spread
0.80
value
-0.6
group Id
OG001
spread
0.15
value
0.1
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 8), n=2,2
categories
measurements
comment
NA indicates that standard deviation could not be calculated for a single participant.
group Id
OG000
spread
NA
value
-1.1
group Id
OG001
spread
0.33
value
0.2
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 9), n=1,2
categories
measurements
comment
NA indicates that standard deviation could not be calculated for a single participant.
group Id
OG000
spread
NA
value
-1.1
group Id
OG001
spread
0.03
value
-0.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 10), n=1,2
categories
measurements
comment
NA indicates that standard deviation could not be calculated for a single participant.
group Id
OG000
spread
NA
value
-1.2
group Id
OG001
spread
0.06
value
-0.1
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 11), n=1,2
categories
measurements
comment
NA indicates that standard deviation could not be calculated for a single participant.
group Id
OG000
spread
NA
value
-1.2
group Id
OG001
spread
0.13
value
0.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 12), n=1,2
categories
measurements
comment
NA indicates that standard deviation could not be calculated for a single participant.
group Id
OG000
spread
NA
value
-1.1
group Id
OG001
spread
0.09
value
0.0
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
2
units
Participants
title
Day 1 (Cycle 13), n=1,2

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
6
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

description
Participants were administered a dose of 3.40 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 3.40 mg/kg
description
Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG001
title
Part 1: GSK2857916 4.60 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, 9, 10, 11, 12, 13, 14, 15, 16)

title

Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 mg/kg

type

PRIMARY

unit Of Measure

Grams per day

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

Preserved source evidence · Not medical advice