Number of Participants With Serious Adverse Events (SAEs) and Common (>=5%) Non-serious Adverse Events- Part 1
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 1 Population comprised of all Part 1 participants (exclusively MM) who received at least one dose of GSK2857916. SAEs and common (>=5%) non-SAEs is presented.
Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (MM)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 2 MM Population comprised of all Part 2 MM participants who received at least one dose of GSK2857916. SAEs and common (>=5%) non-SAEs is presented.
Number of Participants With SAEs and Common (>=5%) Non-serious Adverse Events- Part 2 (NHL)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, other medical events according to medical or scientific judgement and all events of possible study treatment-induced liver injury with hyperbilirubinemia. Part 2 NHL Population comprised of all Part 2 NHL participants who received at least one dose of GSK2857916. SAEs and common (>=5%) non-SAEs is presented.
Number of Participants With Dose-limiting Toxicities (DLTs) During the Determinative Period- Part 1
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of the following criteria:albuminuria>=2000mgper24 hour which has been confirmed by repeat test at least7 days apart and is not considered to be related to disease progression, Grade4 neutropenia (without fever) lasting>=7 days, febrile neutropenia lasting>=72 hours, Grade>=3 thrombocytopenia associated with bleeding where estimated blood loss is>10 milliliter orGrade4 thrombocytopenia lasting>7 days and not responding to platelet transfusions, anyGrade3 or greaternon-hematologic toxicity as described in Common National Cancer Institute-Terminology Criteria for Adverse Events version4.0 with the exception of the following Grade3 events that can be controlled within48 hours with routine supportive measures and clinically asymptomatic electrolyte abnormalities which can be corrected within48 hours and liver toxicity meeting pre-specified GSK liver stopping criteria.
Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 1
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). SBP and DBP were graded using National Cancer Institute-Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. For SBP: Grade 0-<120 millimeters of mercury[mmHg], 120-139 mmHg[Grade 1], 140-159 mmHg[Grade 2], >=160 mmHg[Grade 3]); For DBP: <80 mmHg [Grade 0], 80-89[Grade 1], 90-99[Grade 2], >=100 mmHg[Grade 3]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (MM)
Vital signs included SBP, DBP, Temp and HR. SBP and DBP were graded using NCI CTCAE version 4.0. For SBP: Grade 0-<120 mmHg, 120-139 mmHg[Grade 1], 140-159 mmHg[Grade 2], >=160 mmHg[Grade 3]); For DBP: <80 mmHg [Grade 0], 80-89[Grade 1], 90-99[Grade 2], >=100 mmHg[Grade 3]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (NHL)
Vital signs included SBP, DBP, Temp and HR. SBP and DBP were graded using NCI CTCAE version 4.0. For SBP: Grade 0-<120 mmHg, 120-139 mmHg [Grade 1], 140-159 mmHg[Grade 2], >=160 mmHg [Grade 3]); For DBP: <80 mmHg [Grade 0], 80-89[Grade 1], 90-99[Grade 2], >=100 mmHg[Grade 3]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 1
The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to <60 beats per minute [bpm] and increase to >100 bpm) and change in temperature from Baseline (increase to >=38 or decrease to <=35 degrees celsius). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (MM)
The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to <60 bpm and increase to >100 bpm) and change in temperature from Baseline(increase to >=38 or decrease to <=35 degrees celsius). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Change From Baseline in Heart Rate and Temperature-Part 2 (NHL)
The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to <60 bpm and increase to >100 bpm) and change in temperature from Baseline(increase to >=38 or decrease to <=35 degrees celsius). Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 1
Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (T.Bil.), calcium (Ca), creatinine (Creat), creatinine kinase (CK), gamma glutamyl transferase (GGT), glucose (Gl), potassium (Pot), magnesium (Mg), sodium (Sod), phosphate (Ph) and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. 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. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (MM)
Blood samples were collected for the analysis of following clinical chemistry parameters: albumin,ALP,ALT,AST,T.Bil.,Ca, Creat,CK, GGT,Gl, Pot,Mg, Sod, Ph and urate. Values(Hyper and hypo)for Gl, Pot, Mg, Sod and Ca is presented. 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. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Grade Change From Baseline in Clinical Chemistry Data-Part 2 (NHL)
Blood samples were collected for the analysis of following clinical chemistry parameters: albumin, ALP, ALT, AST, Bilirubin, Ca, Creat, CK, GGT, Glucose, Pot, Mg, Sod, and Ph. Values(Hyper and hypo)for Glucose, Pot, Mg, Sod and Ca is presented. 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. All increases are an increase in grade from Baseline. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 1
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.
Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (MM)
Blood samples were collected for the analysis of following clinical chemistry parameters: D.Bil., chloride, CO2, LDH, T.Pro and 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 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.
Number of Participants With Change From Baseline in Clinical Chemistry Data With Respect to Normal Range-Part 2 (NHL)
Blood samples were collected for the analysis of following clinical chemistry parameters: D.Bil., chloride, CO2, LDH, and T.Pro. 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 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.
Number of Participants With Grade Change From Baseline in Hematology Data-Part 1
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.
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (MM)
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.
Number of Participants With Grade Change From Baseline in Hematology Data-Part 2 (NHL)
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.
Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 1
Blood samples were collected for the analysis of following hematology parameters: basophils (Baso), eosinophils (Eosino), hematocrit (Hct), mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes (Mono), erythrocytes (Erythro) and reticulocytes (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.
Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (MM)
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.
Number of Participants With Change From Baseline in Hematology Data With Respect to Normal Range-Part 2 (NHL)
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.
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 1
Urine samples were collected to assess urine occult blood (OB) and urine protein (Pro). The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (MM)
Urine samples were collected to assess urine OB and urine Pro. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB and no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ for urine Pro indicating proportional concentrations in the urine sample. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Number of Participants With Worst-case Urinalysis Results Post-Baseline Relative to Baseline by Dipstick Method -Part 2 (NHL)
Urine samples were collected to assess urine OB and urine Pro. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as no change/decreased, increase to small (indicated by trace and 1+), increase to moderate (indicated by 2+) and increase to large (indicated by 3+ and above) for urine OB. For Urine Pro., results were reported as no change/decreased, increase to trace, increase to 1+, increase to 2+ and increase to 3+ indicating proportional concentrations in the urine sample. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.06 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.03 mg/kg and 0.12 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.24 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.48 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 0.96 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 1.92 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 2.50 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 1: GSK2857916 3.40 mg/kg and 4.60 mg/kg
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (MM)
Urine samples were collected to assess urine Pro. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Pro. excretion (24 hour) is presented
Change From Baseline in Urine Protein Excretion (24 Hour)-Part 2 (NHL)
Urine samples were collected to assess urine Protein. Baseline was the latest pre-dose assessment with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for change from Baseline in urine Protein excretion (24 hour) is presented.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[0-infinity]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. Pharmacokinetic (PK) parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
AUC[0-infinity] of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Area Under the Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
AUC[0-tau] of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Area Under the Concentration-time Curve From Zero to Time of Last Quantifiable Concentration (AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
AUC[0-tlast]) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Clearance (CL) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
CL of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Maximum Observed Concentration (Cmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Cmax of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Trough Plasma Concentration (Ctrough) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Terminal Half-life (t1/2) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
t1/2 of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Volume of Distribution at Steady State (Vss) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Vss of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Time to Reach Maximum Observed Concentration (Tmax) of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Tmax of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM - Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Ctrough of GSK2857916 Following IV Dose in Participants With Relapsed/Refractory MM-Part 2
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
Ctrough of GSK2857916 Following IV Dose in Participants With NHL-Part 2
Blood samples were collected at designated timepoints. PK parameters of GSK2857916 were calculated using non-compartmental methods.
AUC(0-tlast) of Cys Monomethyl Auristatin F (Cys-mcMMAF) Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
AUC(0-tlast) of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that geometric coefficient of variation could not be calculated for a single participant.
Cmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods.
Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
Ctrough of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM- Part 1
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Tmax of Cys-mcMMAF Following IV Dose of GSK2857916 in Participants With Relapsed/Refractory MM-Part 1: GSK2857916 2.50 mg/kg
Blood samples were collected at designated timepoints. PK parameters of Cys-mcMMAF were calculated using non-compartmental methods. Median and full range of Tmax have been presented.
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody Result- Part 1
Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with at least one confirmed positive ADA at any time post-Baseline is presented.
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody Result- Part 2 (MM)
Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with at least one confirmed positive ADA at any time post-Baseline is presented.
Number of Participants With at Least One Confirmed Positive Post-Baseline Anti-drug Antibody Result- Part 2 (NHL)
Serum samples were collected for the determination of anti-GSK2857916 antibodies (ADA) using a validated ECLimmunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with at least one confirmed positive ADA at any time post-Baseline is presented.
Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 1
Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive (pos) samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative (neg) conclusive ADA results at Baseline and different timepoints is presented.
Number of Participants With Antibodies to GSK2857916 in Serum Over Time- Part 2 (MM)
Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.
Number of Participants With Antibodies to GSK2857916 in Serum Over Time - Part 2 (NHL)
Serum samples were collected for the determination of ADA using a validated ECL immunoassay. The assay involved screening, confirmation and titration steps. If serum samples contained ADA, they were further analyzed for the specificity of antibodies by a confirmation assay. Confirmed positive samples were titrated to obtain the titers of antibodies. The number of participants with screening, confirming and negative conclusive ADA results at Baseline and different timepoints is presented.
Overall Response Rate (ORR)- Part 1
ORR was determined by the investigator according to international myeloma working group uniform response criteria for MM (IMWG 2011). ORR was calculated as the number of participants with best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR).
ORR-Part 2 (MM)
ORR was determined by the investigator according to IMWG 2011 uniform response criteria for MM. ORR was calculated as the number of participants with best overall response of sCR, CR, VGPR and PR.
ORR-Part 2 (NHL)
Overall Response Rate in NHL population was determined by the investigator according to Revised Response Criteria for Malignant Lymphoma. ORR was calculated as the number of participants with confirmed complete remission (CR) or partial remission (PR). Complete remission was defined as disappearance of all evidence of disease and partial remission was defined as regression of measurable disease and no new sites.
Clinical Benefit Rate (CBR)- Part 1
CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and minimal response (MR).
CBR- Part 2
CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and MR.