Number of Participants With Grade Change From Baseline in Hematology Data-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: Hb, Lymph, Neutro, PC, and leuko. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for 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
Hb, Hb increased, any grade increase, 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
Hb, Hb increased, increase to Grade 3, 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
Hb, Hb increased, increase to Grade 4, 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
Hb,Anemia, any grade increase, 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
Hb, Anemia, increase to Grade 3, 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
Hb, Anemia, increase to Grade 4, n=6
Analysis denominator · Participants
Group
Source count
Part 2: GSK2857916 3.40 mg/kg (NHL)
6
Values in Participants · Interval/dispersion: Not reported
Lymph,Lymph count decreased,increase to Grade3,n=6
categories
measurements
group Id
OG000
value
2
denoms
counts
group Id
OG000
value
6
units
Participants
title
Lymph,Lymph count decreased,increase to Grade4,n=6
denoms
counts
group Id
OG000
value
6
units
Participants
description
Blood samples were collected for the analysis of following hematology parameters: Hb, Lymph, Neutro, PC, and leuko. The laboratory parameters were graded according to NCI-CTCAE version 4.0. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences; Grade 5: death related to AE. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for 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 Grade Change From Baseline in Hematology Data-Part 2 (NHL)
Triangle