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NCT02064387 · OUTCOME

Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)

What was measured

Blood samples were collected for the analysis of following hematology parameters: Baso, Eosino, Hct, MCHC, MCH, MCV, Mono, Erythro and Reticu. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline. Data at worst-case post Baseline is presented.

Analysis population: Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

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

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Reported measurements

Baso,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Baso, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	6	Not reported	Not reported	Not reported	Not reported

Baso,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Eosino,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Eosino,to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	6	Not reported	Not reported	Not reported	Not reported

Eosino,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Hct,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	1	Not reported	Not reported	Not reported	Not reported

Hct, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	5	Not reported	Not reported	Not reported	Not reported

Hct,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

MCH,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	1	Not reported	Not reported	Not reported	Not reported

MCH, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	5	Not reported	Not reported	Not reported	Not reported

MCH,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

MCHC,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	1	Not reported	Not reported	Not reported	Not reported

MCHC, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	5	Not reported	Not reported	Not reported	Not reported

MCHC,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

MCV,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	2	Not reported	Not reported	Not reported	Not reported

MCV, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	4	Not reported	Not reported	Not reported	Not reported

MCV,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Mono,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Mono, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	4	Not reported	Not reported	Not reported	Not reported

Mono,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	2	Not reported	Not reported	Not reported	Not reported

Erythro,decrease to low,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	2	Not reported	Not reported	Not reported	Not reported

Erythro, to normal or NC,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	4	Not reported	Not reported	Not reported	Not reported

Erythro,increase to high,n=6

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	6

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Reticu,decrease to low,n=5

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	0	Not reported	Not reported	Not reported	Not reported

Reticu, to normal or NC,n=5

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	4	Not reported	Not reported	Not reported	Not reported

Reticu,increase to high,n=5

Analysis denominator · Participants

Group	Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)	5

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 2: GSK2857916 3.40 mg/kg (NHL)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
Baso,decrease to low,n=6
categories
measurements
group Id
OG000
value
6
denoms
counts
group Id
OG000
value
6
units
Participants
title
Baso, to normal or NC,n=6
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
Baso,increase to high,n=6
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
Eosino,decrease to low,n=6
categories
measurements
group Id
OG000
value
6
denoms
counts
group Id
OG000
value
6
units
Participants
title
Eosino,to normal or NC,n=6
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
Eosino,increase to high,n=6
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
6
units
Participants
title
Hct,decrease to low,n=6
categories
measurements
group Id
OG000
value
5
denoms
counts
group Id
OG000
value
6
units
Participants
title
Hct, to normal or NC,n=6
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
Hct,increase to high,n=6
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
6
units
Participants
title
MCH,decrease to low,n=6
categories
measurements
group Id
OG000
value
5
denoms
counts
group Id
OG000
value
6
units
Participants
title
MCH, to normal or NC,n=6
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
6
units
Participants
title
MCH,increase to high,n=6

denoms

counts
group Id
OG000
value
6
units
Participants

description

Blood samples were collected for the analysis of following hematology parameters: Baso, Eosino, Hct, MCHC, MCH, MCV, Mono, Erythro and Reticu. A laboratory value that was outside the reference range was considered either high abnormal (value above the upper limit of the reference range) or low abnormal (value below the lower limit of the reference range). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or NC' category. Participants were counted twice if the participant 'Decreased to Low' and 'Increased to High' during post-Baseline. Data at worst-case post Baseline is presented.

groups

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

COUNT_OF_PARTICIPANTS

population Description

Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).

reporting Status

POSTED

time Frame

Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)

title

Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (NHL)

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice