Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (MM)
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 24.2 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 MM 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 (MM)
Participants with multiple myeloma 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).
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 (MM)
35
Reported measurements
Baso,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
0
Not reported
Not reported
Not reported
Not reported
Baso, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
33
Not reported
Not reported
Not reported
Not reported
Baso,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
2
Not reported
Not reported
Not reported
Not reported
Eosino,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
7
Not reported
Not reported
Not reported
Not reported
Eosino,to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
26
Not reported
Not reported
Not reported
Not reported
Eosino,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
2
Not reported
Not reported
Not reported
Not reported
Hct,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
4
Not reported
Not reported
Not reported
Not reported
Hct, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
31
Not reported
Not reported
Not reported
Not reported
Hct,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
0
Not reported
Not reported
Not reported
Not reported
MCH,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
7
Not reported
Not reported
Not reported
Not reported
MCH, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Not reported
Not reported
Not reported
Not reported
MCH,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
1
Not reported
Not reported
Not reported
Not reported
MCHC,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
5
Not reported
Not reported
Not reported
Not reported
MCHC, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Not reported
Not reported
Not reported
Not reported
MCHC,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
2
Not reported
Not reported
Not reported
Not reported
MCV,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
6
Not reported
Not reported
Not reported
Not reported
MCV, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Not reported
Not reported
Not reported
Not reported
MCV,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
1
Not reported
Not reported
Not reported
Not reported
Mono,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
4
Not reported
Not reported
Not reported
Not reported
Mono, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
18
Not reported
Not reported
Not reported
Not reported
Mono,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
14
Not reported
Not reported
Not reported
Not reported
Erythro,decrease to low,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
2
Not reported
Not reported
Not reported
Not reported
Erythro, to normal or NC,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
31
Not reported
Not reported
Not reported
Not reported
Erythro,increase to high,n=35
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
35
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
2
Not reported
Not reported
Not reported
Not reported
Reticu,decrease to low,n=28
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
10
Not reported
Not reported
Not reported
Not reported
Reticu, to normal or NC,n=28
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
14
Not reported
Not reported
Not reported
Not reported
Reticu,increase to high,n=28
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (MM)
28
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2: GSK2857916 3.40 mg/kg (MM)
8
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
35
units
Participants
title
Baso,decrease to low,n=35
categories
measurements
group Id
OG000
value
33
denoms
counts
group Id
OG000
value
35
units
Participants
title
Baso, to normal or NC,n=35
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
35
units
Participants
title
Baso,increase to high,n=35
categories
measurements
group Id
OG000
value
7
denoms
counts
group Id
OG000
value
35
units
Participants
title
Eosino,decrease to low,n=35
categories
measurements
group Id
OG000
value
26
denoms
counts
group Id
OG000
value
35
units
Participants
title
Eosino,to normal or NC,n=35
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
35
units
Participants
title
Eosino,increase to high,n=35
categories
measurements
group Id
OG000
value
4
denoms
counts
group Id
OG000
value
35
units
Participants
title
Hct,decrease to low,n=35
categories
measurements
group Id
OG000
value
31
denoms
counts
group Id
OG000
value
35
units
Participants
title
Hct, to normal or NC,n=35
categories
measurements
group Id
OG000
value
0
denoms
counts
group Id
OG000
value
35
units
Participants
title
Hct,increase to high,n=35
categories
measurements
group Id
OG000
value
7
denoms
counts
group Id
OG000
value
35
units
Participants
title
MCH,decrease to low,n=35
categories
measurements
group Id
OG000
value
28
denoms
counts
group Id
OG000
value
35
units
Participants
title
MCH, to normal or NC,n=35
categories
measurements
group Id
OG000
value
1
denoms
counts
group Id
OG000
value
35
units
Participants
title
MCH,increase to high,n=35
denoms
counts
group Id
OG000
value
35
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 multiple myeloma 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 2: GSK2857916 3.40 mg/kg (MM)
param Type
COUNT_OF_PARTICIPANTS
population Description
Part 2 MM 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 24.2 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 (MM)
Triangle