NCT02064387 · OUTCOME

Number of Participants With Grade Change From Baseline in Hematology Data-Part 1

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 21.6 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: hemoglobin (Hb), lymphocytes (Lymph), neutrophils (Neutro), platelet count (PC), and leukocytes (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 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 1 Population

Groups in this outcome

Part 1: GSK2857916 0.03 mg/kg

Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.06 mg/kg

Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.12 mg/kg

Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.24 mg/kg

Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.48 mg/kg

Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 0.96 mg/kg

Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 1.92 mg/kg

Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

Part 1: GSK2857916 2.50 mg/kg

Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).

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 0.03 mg/kg	1
Part 1: GSK2857916 0.06 mg/kg	1
Part 1: GSK2857916 0.12 mg/kg	4
Part 1: GSK2857916 0.24 mg/kg	4
Part 1: GSK2857916 0.48 mg/kg	4
Part 1: GSK2857916 0.96 mg/kg	3
Part 1: GSK2857916 1.92 mg/kg	4
Part 1: GSK2857916 2.50 mg/kg	8
Part 1: GSK2857916 3.40 mg/kg	3
Part 1: GSK2857916 4.60 mg/kg	6

Reported measurements

Hb, Hb increased, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Hb, Hb increased, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Hb, Hb increased, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Hb,Anemia, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	4	Not reported	Not reported	Not reported	Not reported

Hb, Anemia, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Hb, Anemia, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count increased, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count increased, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count increased, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count decreased, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	3	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count decreased, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Lymph, Lymph count decreased, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Neutro, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	4	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	3	Not reported	Not reported	Not reported	Not reported

Neutro, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Neutro, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	1	Not reported	Not reported	Not reported	Not reported

PC, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	6	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	6	Not reported	Not reported	Not reported	Not reported

PC, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	4	Not reported	Not reported	Not reported	Not reported

PC, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	1	Not reported	Not reported	Not reported	Not reported

Leuko, Leukocytosis, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Leuko, Leukocytosis, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Leuko, Leukocytosis, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Leuko, Leuko decreased, any grade increase

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	3	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	1	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	2	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	3	Not reported	Not reported	Not reported	Not reported

Leuko, Leuko decreased, increase to Grade 3

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	0	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	2	Not reported	Not reported	Not reported	Not reported

Leuko, Leuko decreased, increase to Grade 4

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Part 1: GSK2857916 0.03 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.06 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.12 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.24 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.48 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 0.96 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 1.92 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 2.50 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 3.40 mg/kg	Not reported	Not reported	Not reported	Not reported
Part 1: GSK2857916 4.60 mg/kg	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
1
group Id
OG009
value
0
title
Hb, Hb increased, any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Hb, Hb increased, increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Hb, Hb increased, increase to Grade 4
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
2
group Id
OG006
value
1
group Id
OG007
value
3
group Id
OG008
value
2
group Id
OG009
value
4
title
Hb,Anemia, any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
1
title
Hb, Anemia, increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Hb, Anemia, increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Lymph, Lymph count increased, any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Lymph, Lymph count increased, increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
0
title
Lymph, Lymph count increased, increase to Grade 4
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
1
group Id
OG006
value
2
group Id
OG007
value
4
group Id
OG008
value
2
group Id
OG009
value
3
title
Lymph, Lymph count decreased, any grade increase
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
4
group Id
OG008
value
0
group Id
OG009
value
1
title
Lymph, Lymph count decreased, increase to Grade 3
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
0
group Id
OG006
value
0
group Id
OG007
value
0
group Id
OG008
value
0
group Id
OG009
value
2
title
Lymph, Lymph count decreased, increase to Grade 4

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
4
group Id
OG004
value
4
group Id
OG005
value
3
group Id
OG006
value
4
group Id
OG007
value
8
group Id
OG008
value
3
group Id
OG009
value
6
units
Participants

description

groups

description
Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG000
title
Part 1: GSK2857916 0.03 mg/kg
description
Participants were administered a dose of 0.06 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 0.06 mg/kg
description
Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG002
title
Part 1: GSK2857916 0.12 mg/kg
description
Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG003
title
Part 1: GSK2857916 0.24 mg/kg
description
Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG004
title
Part 1: GSK2857916 0.48 mg/kg
description
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG005
title
Part 1: GSK2857916 0.96 mg/kg
description
Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG006
title
Part 1: GSK2857916 1.92 mg/kg
description
Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
id
OG007
title
Part 1: GSK2857916 2.50 mg/kg
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
OG008
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
OG009
title
Part 1: GSK2857916 4.60 mg/kg

param Type

COUNT_OF_PARTICIPANTS

population Description

Part 1 Population

reporting Status

POSTED

time Frame

Baseline and Up to 21.6 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 1

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice