Dose Escalation Study to Investigate the Safety, Pharmaco... | NCT02064387 | Trialant
NCT02064387
Sponsor
GlaxoSmithKline
Status
Completed
Last Update Posted
Aug 11, 2020Actual
Enrollment
79Actual
Phase
Phase 1
Conditions
Multiple Myeloma
Interventions
GSK2857916
Countries
United States
Canada
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02064387
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
117159
Secondary IDs
ID
Type
Description
Link
2013-004549-18
EudraCT Number
Brief Title
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
Official Title
A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of the Antibody Drug Conjugate GSK2857916 in Subjects With Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Jul 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 29, 2014Actual
Primary Completion Date
Aug 31, 2018Actual
Completion Date
Aug 1, 2019Actual
First Submitted Date
Feb 13, 2014
First Submission Date that Met QC Criteria
Feb 13, 2014
First Posted Date
Feb 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2019
Results First Submitted that Met QC Criteria
Aug 28, 2019
Results First Posted Date
Sep 26, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 29, 2020
Last Update Posted Date
Aug 11, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA). The hypothesis is that GSK2857916 can be safely administered to subjects with MM and with BCMA positive malignancies at doses where target engagement can be demonstrated. This study will determine if adequate target engagement of BCMA receptors translates into clinical benefit for subjects with MM and BCMA positive lymphomas. The study will consists of two parts: a Part 1 dose escalation phase and a Part 2 expansion phase for safety, tolerability, PK, PD, and clinical activity testing. The study will enroll a total of approximately 80-95 subjects with relapsed/refractory MM or BCMA-expressing hematologic malignancies. The maximum dose to be administered in this trial will not exceed 5 milligram/kilogram(mg/kg).
Detailed Description
Not provided
Conditions Module
Conditions
Multiple Myeloma
Keywords
Multiple Myeloma
BCMA expressing Lymphomas
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
79Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Schedule 1 Part 1
Experimental
Participants will receive GSK2857916 intravenously over 60 minutes (one dose) every 3 weeks (21 day cycle) for a maximum of 16 cycles.
Drug: GSK2857916
Schedule 2 Part 1
Experimental
Participants may receive GSK2857916 intravenously over 60 minutes (one dose) once weekly for three consecutive weeks followed by 1 week of rest (28 day cycle) for a maximum of 16 cycles.
Drug: GSK2857916
Schedule 1 Part 2
Experimental
Participants will receive the dose and schedule of GSK2857916 evaluated in Part 1 that is selected for further evaluation in Part 2 for up to 16 cycles.
Drug: GSK2857916
Schedule 2 Part 2
Experimental
Participants may receive the dose and schedule of GSK2857916 evaluated in Part 1 that is selected for further evaluation in Part 2 for a maximum of 16 cycles.
Drug: GSK2857916
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK2857916
Drug
A clear or opalescent solution for IV infusion with unit dose strength of 20 mg/mililiter (mL) for multiple dose levels.
Schedule 1 Part 1
Schedule 1 Part 2
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Up to 23.5 months (maximum duration of follow-up from first dose to last contact or death)
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.
Up to 35 months (maximum duration of follow-up from first dose to last contact or death)
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.
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Male or female, 18 years or older (at the time consent is obtained)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Part 1/dose escalation; Histologically or cytologically confirmed diagnosis of Multiple Myeloma in a subject who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, has been pretreated with at least the 3 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within 60 days of completion of the last therapy.
Part 2 /MM cohort; Histologically or cytologically confirmed diagnosis of: Multiple Myeloma in a subject who fulfills all of the following: has undergone stem cell transplant, or is considered transplant ineligible, has been pretreated with at least the 3 following classes of anti-myeloma drugs: alkylators, proteasome inhibitors and immunomodulators, has demonstrated progression on, or within 60 days of completion of the last therapy, and has measurable disease with at least one of the following: serum M-protein >=0.5 gram (g)/decilitre (dL) (>=5 g/Litre (L)), urine M-protein >=200 milligram (mg)/24hour (h).
Serum free light chain (FLC) assay: Involved FLC level >=5 mg/dL (>=50 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65) and biopsy proven plasmacytoma (should be measured within 28 days of Screening Visit).
Part 2/Other BCMA positive Hematologic Malignancies cohort: Subject with one of the following lymphomas: Diffuse Large B-cell Lymphoma (DLBCL) or follicular lymphoma (FL) that exhibits positive BCMA expression on tumor cells as determined by a central laboratory using a validated Immunohistochemistry (IHC) assay. Eligible subjects with BCMA positive malignancies must also fulfill the prior treatment requirements as follows: DLBCL: at least 2 prior lines of systemic therapy containing at least one line of chemo-immunotherapy with anti-CD20 antibody, and either has undergone stem cell transplant or is considered transplant ineligible. FL: at least 2 prior lines of systemic therapy.
Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: transplant was > 100 days prior to study enrolment, no active infection; subject meets the remainder of the eligibility criteria outlined in the study protocol.
Adequate organ system functions as defined below Absolute neutrophil count>=1.0x10^9/L, hemoglobin>=8.0 g/dL, platelet>=50x10^9/L, international normalized ration (INR) <=1.5, Partial thromboplastin time <=1.5xupper limit of normal (ULN), total bilirubin <=1.25xULN, alanine aminotransferase and aspartate aminotransferase<=1.5 X ULN, serum creatinine or calculated creatinine clearance<1.2XULN >=60 mL/min for Part 1;>=50 mL/minute (min) for Part 2 if data supports loosening criteria, Albuminuria<=500 mg/24h, left ventricular ejection fraction >=50%, Troponin<=1xULN, Calcium<=1.1xULN
A female subject is eligible to participate if she is of: Non-childbearing potential or women of childbearing potential must have a negative serum pregnancy test within 72 hours of first dose of study treatment and agree to use effective contraception during the study and for 60 days following the last dose of study treatment.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the time of first dose of study until 60 days after the last dose of study treatment to allow for clearance of any altered sperm
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events, version 4) must be <=Grade 1 at the time of enrollment except for alopecia, and grade 2 neuropathy.
Exclusion Criteria:
Systemic anti-tumor therapy within 14 days, or plasmapheresis within 7 days prior to the first dose of study drug
Use of an investigational drug within 14 days or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drug.
History of an allogeneic stem cell transplant. Subjects with a history of an autologous stem cell transplant are NOT excluded if they meet inclusion criteria related to history of autologous stem cell transplant.
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil the inclusion criteria related to organ system function.
Evidence of active mucosal or internal bleeding
Any major surgery within the last four weeks.
Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures.
Known active infection requiring antibiotic treatment
Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease
Subjects with previous or concurrent malignancies are allowed only if the second tumor is not contributing to the subject's illness. The subject must not be receiving active therapy, other than hormonal therapy for this disease and the disease must be considered medically stable for at least 2 years.
Evidence of cardiovascular risk including any of the following: QT interval corrected>=470 millisecond, evidence of current clinically significant uncontrolled arrhythmias, history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening, Class III or IV heart failure as defined by the New York Heart Association functional classification system, uncontrolled hypertension, subjects with intra-cardiac defibrillators or permanent pacemakers, abnormal cardiac valve morphology (>=grade 2) documented by echocardiogram (subjects with grade 1 abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or any of the components of the study treatment.
Pregnant or lactating female.
Known human immuno virus infection.
Subjects with positive test for Hepatitis B surface (HBS-Ag) or Hepatitis B core (HBc)antigen
Subjects with positive test for hepatitis C (HCV) infection are excluded regardless of viral load. If hepatitis C antibody test is positive, a confirmatory polymerase chain reaction (PCR) or Recombinant immunoblot assay (RIBA) test should be performed. If the PCR or RIBA test is negative, subject is eligible for this trial
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases or otherwise stable chronic liver disease per investigator's assessment).
Current corneal disease or a history of corneal disease.
Trudel S, Lendvai N, Popat R, Voorhees PM, Reeves B, Libby EN, Richardson PG, Hoos A, Gupta I, Bragulat V, He Z, Opalinska JB, Cohen AD. Antibody-drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer J. 2019 Mar 20;9(4):37. doi: 10.1038/s41408-019-0196-6.
IPD for this study will be made available via the Clinical Study Data Request site.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 79 participants were enrolled (38 participants in Part-1 and 41 participants in Part-2).
Recruitment Details
This is a Phase1 study of antibody drug conjugate GSK2857916 in participants with relapsed/refractory multiple myeloma(MM) or non-hodgkin's lymphoma (NHL).The study was conducted in 2 parts-Part1(dose escalation) and Part2(dose expansion).The starting dose in Part1 was 0.03mg/kg GSK2857916 given once every three weeks; 1cycle=21 days for 16cycles.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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).
FG001
Part 1: GSK2857916 0.06 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Part 1 Max 23.5 Months Followup Duration
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 2, 2017
Jul 10, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Schedule 2 Part 1
Schedule 2 Part 2
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Up to Day 21 (from first dose)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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
Baseline and Day 1 (Cycle 2 and 3)
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
Baseline and Day 1 (Cycle 2)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13,14, 15)
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
Baseline and Day 1 (Cycle 2, 3, 5, 6, 7, 8)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14, 16)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, 14, 15, 16)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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.
Baseline and Day 1 (Cycle 2)
Pre-dose, 30 minutes post start of infusion (SOI), at end of infusion (EOI), 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
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.
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
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.
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 3)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
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.
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
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.
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
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.
Pre-dose and EOI of Day 1 (Cycle 1)
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.
Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
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.
Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
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.
Baseline, Day 1 (Cycle 2, 3, 4, 6, 9, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
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.
Baseline, Day 1 (Cycle 2, 3, 6, 7, 9, 11, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
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.
Baseline, Day 1 (Cycle 2, 3), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
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).
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)
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.
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)
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.
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 7.2 months)
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).
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)
CBR- Part 2
CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and MR.
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)
New York
New York
10065
United States
GSK Investigational Site
Chapel Hill
North Carolina
27599-7600
United States
GSK Investigational Site
Philadelphia
Pennsylvania
19104
United States
GSK Investigational Site
Dallas
Texas
75390-8565
United States
GSK Investigational Site
Seattle
Washington
98109
United States
GSK Investigational Site
Vancouver
British Columbia
V5Z 1M9
Canada
GSK Investigational Site
Toronto
Ontario
M5G 2M9
Canada
GSK Investigational Site
London
NW1 2BU
United Kingdom
Derived
Collins J, van Noort M, Rathi C, Post TM, Struemper H, Jewell RC, Ferron-Brady G. Longitudinal efficacy and safety modeling and simulation framework to aid dose selection of belantamab mafodotin for patients with multiple myeloma. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1411-1424. doi: 10.1002/psp4.13016. Epub 2023 Aug 2.
Tai YT, Anderson KC. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy. 2015;7(11):1187-99. doi: 10.2217/imt.15.77. Epub 2015 Sep 15.
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).
FG002
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).
FG003
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).
FG004
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).
FG005
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).
FG006
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).
FG007
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).
FG008
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).
FG009
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).
FG010
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).
FG011
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)
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG0078 subjects
FG0083 subjects
FG0096 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0034 subjects
FG0044 subjects
FG0053 subjects
FG0064 subjects
FG0076 subjects
FG0082 subjects
FG0095 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2 Max 35 Months Followup Duration
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG01035 subjects
FG0116 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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).
BG001
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).
BG002
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).
BG003
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).
BG004
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).
BG005
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).
BG006
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).
BG007
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).
BG008
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).
BG009
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).
BG010
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).
BG011
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)
BG012
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0001
BG0011
BG0024
BG0034
BG0044
BG0053
BG0064
BG0078
BG0083
BG0096
BG01035
BG0116
BG01279
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00049.0± NANA indicates that standard deviation could not be calculated for a single participant.
BG00171.0± NANA indicates that standard deviation could not be calculated for a single participant.
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race
Title
Measurements
Black or African American
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Part 1 Population
Posted
Count of Participants
Participants
Up to 23.5 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG003
Title
Denominators
Categories
Common non-SAE
Title
Measurements
OG0001
OG0011
OG0024
OG003
Primary
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.
Part 2 MM Population
Posted
Count of Participants
Participants
Up to 35 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Primary
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.
Part 2 NHL Population
Posted
Count of Participants
Participants
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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)
Units
Counts
Participants
Primary
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.
DLT Evaluable Population(pop) in Part 1 comprised of All Treated Pop (participants who received at least 1 dose of study treatment) and who received a complete infusion in cycle 1 (once every 3 weeks dosing). Any Part 1 participant in the"All Treated" pop who experiences a DLT, will also be included in the DLT evaluable pop regardless of exposure.
Posted
Count of Participants
Participants
Up to Day 21 (from first dose)
ID
Title
Description
OG000
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).
Primary
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.
Part 1 Population
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
Primary
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.
Part 2 MM Population
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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.
Part 2 NHL Population
Posted
Count of Participants
Participants
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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)
Units
Counts
Participants
OG000
Primary
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.
Part 1 Population
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Primary
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.
Part 2 MM Population
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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.
Part 2 NHL Population
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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)
Units
Counts
Participants
OG000
Primary
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.
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
Part 1: GSK2857916 0.06 mg/kg
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Primary
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.
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Primary
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.
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
Part 1: GSK2857916 0.06 mg/kg
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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)
Units
Counts
Primary
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.
Part 1 Population
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
OG002
Primary
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.
Part 2 MM Population
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Primary
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.
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Primary
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.
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Primary
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.
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).
Posted
Count of Participants
Participants
Baseline and Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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)
Units
Counts
Participants
Primary
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
Part 1 Population. NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2 and 3)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2)
ID
Title
Description
OG000
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).
OG001
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).
Units
Counts
Participants
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed. NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 13,14, 15)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 5, 6, 7, 8)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 11, 12, 13, 14, 16)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 10, 12, 13, 14, 15, 16)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). NA indicates that standard deviation could not be calculated for a single participant.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
ID
Title
Description
OG000
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).
OG001
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).
Units
Primary
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
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).
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Primary
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.
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed.
Posted
Mean
Standard Deviation
Grams per day
Baseline and Day 1 (Cycle 2)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population comprised of Part 1 participants of All Treated Population who had atleast 1 non-missing (non-quantifiable, NQ values were considered non-missing) PK assessment. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 30 minutes post start of infusion (SOI), at end of infusion (EOI), 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*nanogram per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Milliliter per hour
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
ID
Title
Description
OG000
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).
OG001
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).
OG002
Secondary
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.
PK Part 1 Population.Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hours
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 2 MM Population comprised of Part 2 MM participants of All Treated Population who had atleast 1 non-missing (NQ) PK assessment. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Nanograms per milliliter
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
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).
Posted
Mean
Standard Deviation
Nanograms per milliliter
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 3)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*picogram per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1), Pre-dose and EOI of Day 1 (Cycle 2 and Cycle 4)
ID
Title
Description
OG000
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).
OG001
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).
OG002
Part 1: GSK2857916 0.12 mg/kg
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Geometric Mean
Geometric Coefficient of Variation
Picograms per milliliter
Pre-dose and EOI of Day 1 (Cycle 1, Cycle 2 and Cycle 4)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Median
Full Range
Hours
Pre-dose, 30 minutes post-SOI, at EOI, 1, 3, 8 and 24 hours post-EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
PK Part 1 Population. Only those participants with data available at the specified data points were analyzed.
Posted
Pre-dose and EOI of Day 1 (Cycle 1)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
Part 1 Population
Posted
Count of Participants
Participants
Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
OG001
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).
OG002
Part 1: GSK2857916 0.12 mg/kg
Secondary
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.
Part 2 MM Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Up to 24.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
Part 2 NHL Population. Only those participants with data available at the specified data points were analyzed.
Posted
Count of Participants
Participants
Up to 7.2 months (maximum duration of follow-up from first dose to last contact or death)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
Part 1 Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Posted
Count of Participants
Participants
Baseline, Day 1 (Cycle 2, 3, 4, 6, 9, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
ID
Title
Description
OG000
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).
OG001
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).
Secondary
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.
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).
Posted
Count of Participants
Participants
Baseline, Day 1 (Cycle 2, 3, 6, 7, 9, 11, 12, 16), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Secondary
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.
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).
Posted
Count of Participants
Participants
Baseline, Day 1 (Cycle 2, 3), End of study (within 30 days [+ 7 days of last treatment or prior to the start of new anti-cancer treatment], whichever is earlier) (1 cycle=21 days)
ID
Title
Description
OG000
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).
Units
Counts
Participants
Secondary
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).
Part 1 Population
Posted
Count of Participants
Participants
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Secondary
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.
Part 2 MM Population
Posted
Count of Participants
Participants
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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.
Part 2 NHL Population
Posted
Count of Participants
Participants
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 7.2 months)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Secondary
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).
Part 1 Population
Posted
Count of Participants
Participants
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 21.6 months)
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
OG003
Part 1: GSK2857916 0.24 mg/kg
Secondary
CBR- Part 2
CBR was calculated as the number of participants with best overall response of sCR, CR, VGPR, PR and MR.
Part 2 MM Population. Data is presented only for Part 2 MM Population; since this analysis was not planned for Part 2 NHL Population.
Posted
Count of Participants
Participants
From the Start of Treatment (at First Dose) up to the earlier of disease progression or the start of new anti-cancer therapy (maximum duration of follow-up is 24.2 months)
ID
Title
Description
OG000
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).
Units
Counts
Participants
OG000
Time Frame
SAEs & common (>=5%) non-SAEs were collected from start of study treatment until 23.5 months for Part 1, 35 months for Part 2 (MM) and 7.2 months for Part 2 (NHL)
Description
SAEs and common (>=5%) non-SAEs were reported by treatment for the Part 1 Population which comprised of all Part 1 participants (exclusively MM) who received at least one dose of GSK2857916; Part 2 MM and NHL Population which comprised of all Part 2 MM and NHL participants who received at least one dose of GSK2857916.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
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).
0
1
0
1
1
1
EG001
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).
0
1
0
1
1
1
EG002
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).
0
4
1
4
4
4
EG003
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).
0
4
1
4
4
4
EG004
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).
0
4
1
4
3
4
EG005
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).
0
3
0
3
3
3
EG006
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).
0
4
2
4
4
4
EG007
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).
1
8
4
8
8
8
EG008
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).
0
3
1
3
3
3
EG009
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).
1
6
3
6
6
6
EG010
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).
5
35
17
35
35
35
EG011
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).
3
6
3
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Adenovirus infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
Appendicitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Babesiosis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hyperviscosity syndrome
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Limbal stem cell deficiency
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Retinal detachment
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Salmonellosis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0102 events2 affected35 at risk
EG0110 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Albuminuria
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Alpha haemolytic streptococcal infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Angina bullosa haemorrhagica
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Asthenia
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Babesiosis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Borderline glaucoma
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Bundle branch block right
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Catheter site discharge
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Conjunctivitis viral
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Corneal deposits
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Corneal disorder
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Corneal irritation
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Corneal oedema
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Corneal opacity
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected4 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Decubitus ulcer
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Diplopia
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Disturbance in attention
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Eye pruritus
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Facial nerve disorder
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Facial pain
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Fatigue
General disorders
MedDRA22.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Flushing
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Foreign body sensation in eyes
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Gait disturbance
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events1 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected4 at risk
EG003
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hypophagia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Influenza
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Keratitis
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Keratopathy
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Lip pain
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Malaise
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Migraine
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0022 events2 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Ocular hypertension
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Ocular toxicity
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Optic disc haemorrhage
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Photophobia
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Photopsia
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Platelet count decreased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0023 events1 affected4 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Punctate keratitis
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Sinusitis
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Skin hypopigmentation
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Spinal cord injury thoracic
Injury, poisoning and procedural complications
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Telangiectasia
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA22.1
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Tooth infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract pain
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected1 at risk
EG0020 events0 affected4 at risk
EG003
White blood cell count decreased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0021 events1 affected4 at risk
EG003
Blood immunoglobulin G decreased
Investigations
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Periorbital swelling
Eye disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA22.1
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Lymph,Lymph count decreased,increase to Grade3,n=6
ParticipantsOG0006
Title
Measurements
OG0003
Lymph,Lymph count decreased,increase to Grade4,n=6
ParticipantsOG0006
Title
Measurements
OG0002
Neutro, any grade increase, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Neutro, increase to Grade 3, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Neutro, increase to Grade 4, n=6
ParticipantsOG0006
Title
Measurements
OG0000
PC, any grade increase, n=5
ParticipantsOG0005
Title
Measurements
OG0003
PC, increase to Grade 3, n=5
ParticipantsOG0005
Title
Measurements
OG0000
PC, increase to Grade 4, n=5
ParticipantsOG0005
Title
Measurements
OG0001
Leuko, Leukocytosis, any grade increase, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Leuko, Leukocytosis, increase to Grade 3, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Leuko, Leukocytosis, increase to Grade 4, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Leuko, Leuko decreased, any grade increase, n=6
ParticipantsOG0006
Title
Measurements
OG0004
Leuko, Leuko decreased, increase to Grade 3, n=6
ParticipantsOG0006
Title
Measurements
OG0000
Leuko, Leuko decreased, increase to Grade 4, n=6
ParticipantsOG0006
Title
Measurements
OG0000
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).
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
Baso,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baso, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Baso,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Eosino,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Eosino,to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Eosino,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Hct,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Hct, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Hct,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCH,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCH, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCH,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCHC,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCHC, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCHC,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCV,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCV, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
MCV,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Mono,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Mono, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Mono,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Erythro,decrease to low,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Erythro, to normal or NC,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Erythro,increase to high,n=1,1,4,4,4,3,4,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Reticu,decrease to low,n=1,1,3,3,2,1,4,8,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
Reticu,to normal or NC,n=1,1,3,3,2,1,4,8,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
Reticu,increase to high,n=1,1,3,3,2,1,4,8,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0023
ParticipantsOG0033
Participants
OG00035
Title
Denominators
Categories
Baso,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0000
Baso, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00033
Baso,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0002
Eosino,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0007
Eosino,to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00026
Eosino,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0002
Hct,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0004
Hct, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00031
Hct,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0000
MCH,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0007
MCH, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00028
MCH,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0001
MCHC,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0005
MCHC, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00028
MCHC,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0002
MCV,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0006
MCV, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00028
MCV,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0001
Mono,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0004
Mono, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00018
Mono,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG00014
Erythro,decrease to low,n=35
ParticipantsOG00035
Title
Measurements
OG0002
Erythro, to normal or NC,n=35
ParticipantsOG00035
Title
Measurements
OG00031
Erythro,increase to high,n=35
ParticipantsOG00035
Title
Measurements
OG0002
Reticu,decrease to low,n=28
ParticipantsOG00028
Title
Measurements
OG00010
Reticu, to normal or NC,n=28
ParticipantsOG00028
Title
Measurements
OG00014
Reticu,increase to high,n=28
ParticipantsOG00028
Title
Measurements
OG0008
Participants
OG0006
Title
Denominators
Categories
Baso,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Baso, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0006
Baso,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Eosino,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Eosino,to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0006
Eosino,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Hct,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0001
Hct, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0005
Hct,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
MCH,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0001
MCH, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0005
MCH,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
MCHC,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0001
MCHC, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0005
MCHC,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
MCV,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0002
MCV, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0004
MCV,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Mono,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Mono, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0004
Mono,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0002
Erythro,decrease to low,n=6
ParticipantsOG0006
Title
Measurements
OG0002
Erythro, to normal or NC,n=6
ParticipantsOG0006
Title
Measurements
OG0004
Erythro,increase to high,n=6
ParticipantsOG0006
Title
Measurements
OG0000
Reticu,decrease to low,n=5
ParticipantsOG0005
Title
Measurements
OG0000
Reticu, to normal or NC,n=5
ParticipantsOG0005
Title
Measurements
OG0004
Reticu,increase to high,n=5
ParticipantsOG0005
Title
Measurements
OG0001
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
OB,No change/decreased, n=1,1,4,4,2,3,3,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0023
OG003
OB,Increase to small, n=1,1,4,4,2,3,3,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
OB,Increase to moderate, n=1,1,4,4,2,3,3,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
OB,Increase to large, n=1,1,4,4,2,3,3,8,3,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Pro,No change/decreased, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
Pro,Increase to trace, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
Pro,Increase to 1+, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
Pro,Increase to 2+, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
Pro,Increase to 3+, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
Pro,Unknown, n=1,1,4,3,2,3,4,5,3,5
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0033
OG00035
Title
Denominators
Categories
OB,No change/decreased, n=33
ParticipantsOG00033
Title
Measurements
OG00018
OB,Increase to small, n=33
ParticipantsOG00033
Title
Measurements
OG00014
OB,Increase to moderate, n=33
ParticipantsOG00033
Title
Measurements
OG0001
OB,Increase to large, n=33
ParticipantsOG00033
Title
Measurements
OG0000
Pro,No change/decreased, n=31
ParticipantsOG00031
Title
Measurements
OG00015
Pro,Increase to trace, n=31
ParticipantsOG00031
Title
Measurements
OG00011
Pro,Increase to 1+, n=31
ParticipantsOG00031
Title
Measurements
OG0001
Pro,Increase to 2+, n=31
ParticipantsOG00031
Title
Measurements
OG0000
Pro,Increase to 3+, n=31
ParticipantsOG00031
Title
Measurements
OG0000
Pro,Unknown, n=31
ParticipantsOG00031
Title
Measurements
OG0004
OG0005
Title
Denominators
Categories
OB,No change/decreased, n=5
ParticipantsOG0005
Title
Measurements
OG0004
OB,Increase to small, n=5
ParticipantsOG0005
Title
Measurements
OG0000
OB,Increase to moderate, n=5
ParticipantsOG0005
Title
Measurements
OG0000
OB,Increase to large, n=5
ParticipantsOG0005
Title
Measurements
OG0001
Pro,No change/decreased, n=4
ParticipantsOG0004
Title
Measurements
OG0003
Pro,Increase to trace, n=4
ParticipantsOG0004
Title
Measurements
OG0001
Pro,Increase to 1+, n=4
ParticipantsOG0004
Title
Measurements
OG0000
Pro,Increase to 2+, n=4
ParticipantsOG0004
Title
Measurements
OG0000
Pro,Increase to 3+, n=4
ParticipantsOG0004
Title
Measurements
OG0000
1
Title
Denominators
Categories
Day 1 (Cycle 2)
Title
Measurements
OG000-0.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 3)
Title
Measurements
OG0000.3± NANA indicates that standard deviation could not be calculated for a single participant.
OG0003
OG0010
Title
Denominators
Categories
Title
Measurements
OG0000.4± 0.72
1
Title
Denominators
Categories
Day 1 (Cycle 2)
Title
Measurements
OG000-0.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 3)
Title
Measurements
OG000-0.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 4)
Title
Measurements
OG00088.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 5)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 6)
Title
Measurements
OG000-0.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 7)
Title
Measurements
OG000-0.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 8)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 9)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 10)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 12)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 13)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 14)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 15)
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant.
4
Title
Denominators
Categories
Day 1 (Cycle 2), n=2
ParticipantsOG0002
Title
Measurements
OG0000.0± 0.04
Day 1 (Cycle 3), n=1
ParticipantsOG0001
Title
Measurements
OG0000.8± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 5), n=1
ParticipantsOG0001
Title
Measurements
OG0000.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 6), n=1
ParticipantsOG0001
Title
Measurements
OG0000.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 7), n=1
ParticipantsOG0001
Title
Measurements
OG0000.1± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 8), n=1
ParticipantsOG0001
Title
Measurements
OG0000.1± NANA indicates that standard deviation could not be calculated for a single participant.
3
Title
Denominators
Categories
Day 1 (Cycle 2), n=2
ParticipantsOG0002
Title
Measurements
OG0000.2± 0.35
Day 1 (Cycle 3), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.1± 0.07
Day 1 (Cycle 4), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.1± NANA indicates that standard deviation could not be calculated for a single participant
Day 1 (Cycle 5), n=1
ParticipantsOG0001
Title
Measurements
OG0000.0± NANA indicates that standard deviation could not be calculated for a single participant
Day 1 (Cycle 6), n=1
ParticipantsOG0001
Title
Measurements
OG0000.2± NANA indicates that standard deviation could not be calculated for a single participant
4
Title
Denominators
Categories
Day 1 (Cycle 2), n=3
ParticipantsOG0003
Title
Measurements
OG000-0.1± 0.48
Day 1 (Cycle 3), n=3
ParticipantsOG0003
Title
Measurements
OG000-30.3± 51.72
Day 1 (Cycle 4), n=4
ParticipantsOG0004
Title
Measurements
OG000-22.4± 45.06
Day 1 (Cycle 5), n=3
ParticipantsOG0003
Title
Measurements
OG0000.2± 1.42
Day 1 (Cycle 6), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.6± 0.99
Day 1 (Cycle 7), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.6± 1.16
Day 1 (Cycle 8), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.6± 1.06
Day 1 (Cycle 11), n=1
ParticipantsOG0001
Title
Measurements
OG000-1.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 12), n=1
ParticipantsOG0001
Title
Measurements
OG000-1.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 13), n=1
ParticipantsOG0001
Title
Measurements
OG000-1.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 14), n=1
ParticipantsOG0001
Title
Measurements
OG000-1.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 16), n=1
ParticipantsOG0001
Title
Measurements
OG000-1.3± NANA indicates that standard deviation could not be calculated for a single participant.
8
Title
Denominators
Categories
Day 1 (Cycle 2), n=4
ParticipantsOG0004
Title
Measurements
OG0000.8± 1.54
Day 1 (Cycle 3), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.2± 0.31
Day 1 (Cycle 4), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.2± 0.38
Day 1 (Cycle 5), n=1
ParticipantsOG0001
Title
Measurements
OG0000.0± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 6), n=2
ParticipantsOG0002
Title
Measurements
OG000-0.2± 0.33
Day 1 (Cycle 7), n=1
ParticipantsOG0001
Title
Measurements
OG0000.2± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 8), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.5± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 10), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 12), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.5± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 13), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.5± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 14), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.4± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 15), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.5± NANA indicates that standard deviation could not be calculated for a single participant.
Day 1 (Cycle 16), n=1
ParticipantsOG0001
Title
Measurements
OG000-0.5± NANA indicates that standard deviation could not be calculated for a single participant.
Counts
Participants
OG0003
OG0016
Title
Denominators
Categories
Day 1 (Cycle 2), n=2,5
ParticipantsOG0002
ParticipantsOG0015
Title
Measurements
OG000-0.6± 0.83
OG0010.0± 0.45
Day 1 (Cycle 3), n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG000-0.6± 0.81
OG001
Day 1 (Cycle 4), n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG000-0.7± 0.79
OG001
Day 1 (Cycle 5), n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG000-0.6± 0.78
OG001
Day 1 (Cycle 6), n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG000-0.6± 0.80
OG001
Day 1 (Cycle 7), n=2,4
ParticipantsOG0002
ParticipantsOG0014
Title
Measurements
OG000-0.6± 0.79
OG001
Day 1 (Cycle 8), n=2,2
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG000-0.6± 0.80
OG001
Day 1 (Cycle 9), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.1± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 10), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.1± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 11), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.2± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 12), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.2± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 13), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.1± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 14), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.0± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 15), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.1± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
Day 1 (Cycle 16), n=1,2
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG000-1.2± NANA indicates that standard deviation could not be calculated for a single participant.
OG001
35
Title
Denominators
Categories
Day 1 (Cycle 2), n=24
ParticipantsOG00024
Title
Measurements
OG000-0.5± 1.21
Day 1 (Cycle 3), n=18
ParticipantsOG00018
Title
Measurements
OG000-0.7± 1.29
Day 1 (Cycle 4), n=13
ParticipantsOG00013
Title
Measurements
OG000-0.7± 1.65
Day 1 (Cycle 5), n=15
ParticipantsOG00015
Title
Measurements
OG000-0.7± 1.66
Day 1 (Cycle 6), n=14
ParticipantsOG00014
Title
Measurements
OG000-0.8± 1.69
Day 1 (Cycle 7), n=14
ParticipantsOG00014
Title
Measurements
OG000-0.9± 1.56
Day 1 (Cycle 8), n=16
ParticipantsOG00016
Title
Measurements
OG000-0.7± 1.53
Day 1 (Cycle 9), n=13
ParticipantsOG00013
Title
Measurements
OG000-0.5± 1.01
Day 1 (Cycle 10), n=12
ParticipantsOG00012
Title
Measurements
OG000-0.4± 1.06
Day 1 (Cycle 11), n=10
ParticipantsOG00010
Title
Measurements
OG000-0.4± 1.01
Day 1 (Cycle 12), n=10
ParticipantsOG00010
Title
Measurements
OG000-0.4± 1.11
Day 1 (Cycle 13), n=9
ParticipantsOG0009
Title
Measurements
OG000-0.4± 1.27
Day 1 (Cycle 14), n=9
ParticipantsOG0009
Title
Measurements
OG000-0.4± 1.25
Day 1 (Cycle 15), n=9
ParticipantsOG0009
Title
Measurements
OG000-0.4± 1.30
Day 1 (Cycle 16), n=9
ParticipantsOG0009
Title
Measurements
OG000-0.3± 1.35
2
Title
Denominators
Categories
Title
Measurements
OG0000.0± 0.18
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0033
OG0043
OG0052
OG0061
OG0070
OG0084
Title
Denominators
Categories
Title
Measurements
OG001215803.06± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG002767285.51± 49.51
OG003632339.28± 101.14
OG0042991509.97± 72.12
OG0059235256.20± 46.65
OG00618469186.92± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0088355209.26± 25.29
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0034
OG0043
OG0053
OG0063
OG0072
OG0086
Title
Denominators
Categories
Title
Measurements
OG001200467.82± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG002633446.78± 35.42
OG003729443.84± 91.22
OG0042389114.19± 51.12
OG0054448319.69± 79.51
OG0069892863.42± 51.81
OG00723121531.16± 6.59
OG0089738914.76± 38.82
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG00044260.79± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG001178485.20± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG002637783.48± 35.67
OG003694825.13± 107.50
OG0042170746.96± 59.81
OG0054492292.65± 82.00
OG00610093784.72± 54.20
OG00719239850.61± 53.15
OG00810131666.86± 47.32
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0033
OG0043
OG0052
OG0061
OG0070
OG0084
Title
Denominators
Categories
Title
Measurements
OG00128.27± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG00210.53± 58.94
OG00325.01± 88.61
OG00415.10± 75.16
OG0058.46± 27.46
OG00611.68± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG00838.84± 37.53
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG000429.00± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0011323.00± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0022956.77± 18.45
OG0034548.10± 20.27
OG00411876.46± 24.08
OG00523050.05± 23.05
OG00643774.18± 45.18
OG00768128.02± 20.84
OG008117385.57± 24.14
0
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0073
OG0086
Title
Denominators
Categories
Day 1, Cycle 1,n=0,1,4,2,1,3,3,2,6
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0086
Title
Measurements
OG001NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG002381.95± 105.55
OG0031331.11± 44.43
OG004
Day 1, Cycle 2,n=0,1,0,2,1,2,2,2,5
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
Day 1, Cycle 4,n=0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
8
Title
Denominators
Categories
Day 1, Cycle 1,n=8
ParticipantsOG0008
Title
Measurements
OG0003726.78± 49.92
Day 1, Cycle 2,n=4
ParticipantsOG0004
Title
Measurements
OG00011352.94± 268.64
Day 1, Cycle 4,n=3
ParticipantsOG0003
Title
Measurements
OG00011121.73± 59.75
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0033
OG0043
OG0052
OG0061
OG0070
OG0084
Title
Denominators
Categories
Title
Measurements
OG001126.18± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG002188.20± 37.41
OG003117.82± 76.00
OG004198.48± 50.42
OG005264.93± 46.73
OG006308.39± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG008103.74± 17.29
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0011
OG0024
OG0033
OG0043
OG0052
OG0061
OG0070
OG0084
Title
Denominators
Categories
Title
Measurements
OG0015239± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0022900± 29.04
OG0034286± 31.29
OG0044388± 21.99
OG0053224± 22.37
OG0065156± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0085215± 19.41
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG0002.080(2.08 to 2.08)
OG0014.080(4.08 to 4.08)
OG0021.185(1.00 to 2.00)
OG0033.085(2.00 to 8.78)
OG0041.000(1.00 to 4.00)
OG0052.050(2.00 to 2.08)
OG0061.000(0.50 to 24.00)
OG0076.920(2.02 to 8.78)
OG0081.560(0.95 to 2.07)
0
35
Title
Denominators
Categories
Day 1, Cycle 1,n=28
ParticipantsOG00028
Title
Measurements
OG0003486.49± 85.71
Day 1, Cycle 2,n=18
ParticipantsOG00018
Title
Measurements
OG0005799.89± 66.52
Day 1, Cycle 4,n=12
ParticipantsOG00012
Title
Measurements
OG0006184.46± 103.79
5
Title
Denominators
Categories
Cycle 1 Day 1, n=5
ParticipantsOG0005
Title
Measurements
OG0000.0± 0.00
Cycle 2 Day 1, n=4
ParticipantsOG0004
Title
Measurements
OG0003761.8± 2225.57
Cycle 3 Day 1, n=1
ParticipantsOG0001
Title
Measurements
OG0008401.0± NANA indicates that standard deviation could not be calculated for a single participant.
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG0021157.46± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0031623.87± 41.43
OG00414681.62± 91.88
OG00520787.48± 209.27
OG00672608.00± 17.60
OG007119177.30± 35.77
OG008181147.61± 94.32
0
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG00251.50± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG00391.49± 31.76
OG004260.62± 15.70
OG005488.29± 38.51
OG0061054.02± 18.96
OG0071199.86± 35.11
OG0082544.02± 87.04
0
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0073
OG0086
Title
Denominators
Categories
Day 1, Cycle 1,n=0,1,4,2,1,3,3,2,6
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0032
ParticipantsOG0041
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0072
ParticipantsOG0086
Title
Measurements
OG001NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG002NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG003NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG004
Day 1, Cycle 2,n=0,1,0,2,1,2,2,2,5
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
Day 1, Cycle 4,n=0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
8
Title
Denominators
Categories
Day 1, Cycle 1,n=8
ParticipantsOG0008
Title
Measurements
OG000NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
Day 1, Cycle 2,n=4
ParticipantsOG0004
Title
Measurements
OG000NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
Day 1, Cycle 4,n=3
ParticipantsOG0003
Title
Measurements
OG000NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0034
OG0043
OG0053
OG0063
OG0073
OG0086
Title
Denominators
Categories
Title
Measurements
OG00249.130(49.13 to 49.13)
OG00323.875(9.00 to 24.63)
OG00424.730(24.00 to 25.83)
OG0059.050(8.78 to 22.83)
OG0068.750(7.75 to 24.00)
OG00723.700(23.17 to 24.97)
OG00824.040(7.83 to 25.00)
0
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
33
Title
Denominators
Categories
Title
Measurements
OG0000
5
Title
Denominators
Categories
Title
Measurements
OG0000
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
Baseline,screening,pos, n=1,1,4,4,4,3,4,7,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0077
ParticipantsOG0082
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG003
Baseline,screening,neg, n=1,1,4,4,4,3,4,7,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Baseline,confirming,pos,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Baseline,confirming,neg,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Baseline,neg,conclusive,n=1,1,4,4,4,3,4,7,2,6
ParticipantsOG0001
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG0034
Cycle 2 Day 1,screening,pos, n=0,1,4,2,2,3,3,8,3,5
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Cycle 2 Day 1,screening,neg, n=0,1,4,2,2,3,3,8,3,5
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Cycle 2 Day 1,confirming,pos,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 2 Day 1,confirming,neg,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 2 Day 1,neg,conclusive,n=0,1,4,2,2,3,3,8,3,5
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0024
ParticipantsOG003
Cycle 3 Day 1,screening,pos, n=0,1,0,2,2,1,2,4,3,6
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Cycle 3 Day 1,screening,neg, n=0,1,0,2,2,1,2,4,3,6
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Cycle 3 Day 1,confirming,pos,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 3 Day 1,confirming,neg,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 3 Day 1,neg,conclusive,n=0,1,0,2,2,1,2,4,3,6
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG003
Cycle 4 Day 1,screening,pos, n=0,0,0,0,0,0,0,0,0,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 4 Day 1,screening,neg, n=0,0,0,0,0,0,0,0,0,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 4 Day 1,confirming,pos,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 4 Day 1,confirming,neg,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 4 Day 1,neg,conclusive,n=0,0,0,0,0,0,0,0,0,1
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 6 Day 1,screening,pos, n=0,0,0,1,1,1,2,3,3,3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 6 Day 1,screening,neg, n=0,0,0,1,1,1,2,3,3,3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 6 Day 1,confirming,pos,n=0,0,0,0,0,0,0,0,1,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 6 Day 1,confirming,neg,n=0,0,0,0,0,0,0,0,1,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 6 Day 1,neg,conclusive,n=0,0,0,1,1,1,2,3,3,3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 9 Day 1,screening,pos, n=0,0,0,1,0,0,1,1,2,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 9 Day 1,screening,neg, n=0,0,0,1,0,0,1,1,2,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 9 Day 1,confirming,pos,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 9 Day 1,confirming,neg,n=0,0,0,0,0,0,0,0,0,0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 9 Day 1,neg,conclusive,n=0,0,0,1,0,0,1,1,2,2
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 12 Day 1,screening,pos,n=0,0,0,1,0,0,1,1,1,3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Cycle 12 Day 1,screening,neg,n=0,0,0,1,0,0,1,1,1,3
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0061
OG0071
OG0083
OG0093
35
Title
Denominators
Categories
Title
Measurements
OG00021
6
Title
Denominators
Categories
Title
Measurements
OG0000
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
Units
Counts
Participants
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0064
OG0078
OG0083
OG0096
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0051
OG0062
OG0072
OG0083
OG0095
35
Title
Denominators
Categories
Title
Measurements
OG00021
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0102 events2 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected6 at risk
EG0105 events5 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0102 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0101 events1 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0102 events2 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0081 events1 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected6 at risk
EG0108 events7 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0054 events2 affected3 at risk
EG0061 events1 affected4 at risk
EG0073 events3 affected8 at risk
EG0080 events0 affected3 at risk
EG0094 events3 affected6 at risk
EG01012 events10 affected35 at risk
EG0111 events1 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
1 events
1 affected
4 at risk
EG0042 events2 affected4 at risk
EG0050 events0 affected3 at risk
EG0064 events1 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0105 events4 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0071 events1 affected8 at risk
EG0083 events2 affected3 at risk
EG0095 events4 affected6 at risk
EG01017 events13 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0061 events1 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0100 events0 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0041 events1 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0073 events2 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0107 events7 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected8 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected6 at risk
EG0107 events5 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0072 events2 affected8 at risk
EG0081 events1 affected3 at risk
EG0092 events2 affected6 at risk
EG0103 events3 affected35 at risk
EG0111 events1 affected6 at risk
1 events
1 affected
4 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected8 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected6 at risk
EG0104 events2 affected35 at risk
EG0110 events0 affected6 at risk
0 events
0 affected
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2
OG0043
OG0051
OG0063
OG0077
OG0082
OG0095
2
OG0041
OG0050
OG0061
OG0073
OG0081
OG0091
1
OG0043
OG0053
OG0062
OG0071
OG0081
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
OG0044
OG0052
OG0064
OG0078
OG0082
OG0096
0
OG0040
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OG0090
1
OG0044
OG0050
OG0064
OG0076
OG0080
OG0094
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
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Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
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Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
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OG0090
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ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
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Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0071
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
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OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
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Title
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OG0030
OG0040
OG0050
OG0060
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OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
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Title
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Title
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Title
Measurements
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ParticipantsOG0044
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Title
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Title
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OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0032
OG0041
OG0050
OG0061
OG0075
OG0081
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0022
OG0032
OG0041
OG0051
OG0063
OG0076
OG0083
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0082
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0073
OG0083
OG0093
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0022
OG0030
OG0041
OG0051
OG0061
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0041
OG0050
OG0063
OG0073
OG0083
OG0094
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0041
OG0052
OG0060
OG0071
OG0081
OG0092
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0073
OG0080
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0021
OG0032
OG0042
OG0051
OG0063
OG0072
OG0080
OG0093
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0063
OG0072
OG0080
OG0091
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0090
4
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0082
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0071
OG0080
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0001
OG0011
OG0023
OG0032
OG0041
OG0053
OG0064
OG0073
OG0083
OG0093
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0074
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0050
OG0060
OG0070
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0051
OG0061
OG0073
OG0080
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0023
OG0034
OG0042
OG0052
OG0063
OG0074
OG0082
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0081
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0021
OG0033
OG0041
OG0051
OG0063
OG0072
OG0082
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0023
OG0031
OG0043
OG0052
OG0060
OG0075
OG0081
OG0094
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0071
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0022
OG0032
OG0041
OG0052
OG0061
OG0075
OG0081
OG0091
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0022
OG0031
OG0041
OG0051
OG0063
OG0073
OG0082
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0072
OG0082
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0024
OG0033
OG0042
OG0052
OG0063
OG0076
OG0081
OG0094
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0042
OG0051
OG0061
OG0070
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0042
OG0050
OG0060
OG0071
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0022
OG0033
OG0042
OG0053
OG0063
OG0075
OG0082
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0031
OG0040
OG0050
OG0061
OG0072
OG0081
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
2
OG0042
OG0052
OG0061
OG0073
OG0082
OG0094
1
OG0041
OG0051
OG0060
OG0070
OG0080
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0042
OG0051
OG0062
OG0074
OG0082
OG0093
0
OG0040
OG0050
OG0060
OG0074
OG0080
OG0091
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0092
1
OG0040
OG0052
OG0061
OG0074
OG0082
OG0093
1
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
3
OG0041
OG0051
OG0062
OG0076
OG0083
OG0096
2
OG0040
OG0051
OG0060
OG0070
OG0082
OG0094
0
OG0041
OG0050
OG0060
OG0070
OG0080
OG0091
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
1
OG0041
OG0051
OG0063
OG0071
OG0082
OG0093
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0063
OG0078
OG0083
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0093
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0023
OG0034
OG0044
OG0052
OG0064
OG0078
OG0083
OG0094
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0092
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0051
OG0060
OG0071
OG0081
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0024
OG0033
OG0044
OG0052
OG0064
OG0077
OG0081
OG0096
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0081
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0063
OG0073
OG0081
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0024
OG0034
OG0043
OG0053
OG0061
OG0075
OG0082
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
OG0050
OG0060
OG0071
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0051
OG0061
OG0073
OG0081
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0010
OG0024
OG0033
OG0044
OG0052
OG0063
OG0075
OG0082
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0062
OG0070
OG0081
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0010
OG0024
OG0034
OG0044
OG0053
OG0062
OG0078
OG0082
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0071
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0011
OG0023
OG0033
OG0044
OG0053
OG0062
OG0075
OG0080
OG0091
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0010
OG0021
OG0031
OG0040
OG0050
OG0062
OG0073
OG0083
OG0095
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0080
OG0090
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0024
OG0034
OG0044
OG0053
OG0063
OG0076
OG0082
OG0096
ParticipantsOG0044
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0081
OG0090
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0082
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0050
OG0060
OG0073
OG0081
OG0091
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0082
ParticipantsOG0096
Title
Measurements
OG0001
OG0011
OG0021
OG0033
OG0041
OG0050
OG0061
OG0074
OG0081
OG0094
ParticipantsOG0042
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0078
ParticipantsOG0082
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0063
OG0071
OG0080
OG0091
3
OG0041
OG0052
OG0061
OG0075
OG0082
OG0095
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0041
OG0051
OG0062
OG0073
OG0081
OG0090
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG0078
ParticipantsOG0083
ParticipantsOG0096
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0001
OG0010
OG0023
OG0033
OG0042
OG0051
OG0063
OG0071
OG0081
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG0051
OG0060
OG0074
OG0082
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0061
OG0070
OG0080
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
OG0060
OG0070
OG0080
OG0091
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
ParticipantsOG0042
ParticipantsOG0053
ParticipantsOG0064
ParticipantsOG0075
ParticipantsOG0083
ParticipantsOG0095
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0091
-0.0
± 0.23
-0.1
± 0.25
-0.1
± 0.46
-0.0
± 0.33
-0.1
± 0.48
0.1
± 0.15
0.2
± 0.33
-0.0
± 0.03
-0.1
± 0.06
0.0
± 0.13
0.0
± 0.09
0.3
± 0.11
0.1
± 0.10
0.4
± 0.11
4307.00
± NA
NA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0053720.27± 113.71
OG00611420.61± 35.70
OG00728134.46± 35.97
OG0082301.18± 75.69
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0085
Title
Measurements
OG001NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG0031672.18± 28.76
OG0047259.00± NANA indicates that geometric coefficient of variation could not be calculated for a single participant.
OG0059510.04± 104.56
OG00612791.83± 46.82
OG00712719.77± 6.21
OG0082643.94± 123.56
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
NA
± NA
NA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG005NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG006NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG007NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG008NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
ParticipantsOG0041
ParticipantsOG0052
ParticipantsOG0062
ParticipantsOG0072
ParticipantsOG0085
Title
Measurements
OG001NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG003NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG004NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG005NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG006NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG007NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.
OG008NA± NANA indicates that the geometric mean and geometric coefficient of variation could not be calculated since the concentration was not quantifiable.