NCT02064387 · OUTCOME

Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-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 clinical chemistry parameters: direct bilirubin (D.Bil.), chloride, carbon dioxide (CO2), lactate dehydrogenase (LDH), total protein (T.Pro) and urea or blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value, including unscheduled visits. A laboratory value that is 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). If values were unchanged (example: High to High), or whose value became normal, were recorded in the 'To Normal or No Change (NC)' category. Participants were counted twice if the participant "Decreased to low" and "Increased to high" during post-Baseline. Data for worst-case post Baseline 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).

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.