A Study of an Anti-KIR Antibody Lirilumab in Combination... | NCT01714739 | Trialant
NCT01714739
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Feb 2, 2023Actual
Enrollment
337Actual
Phase
Phase 1Phase 2
Conditions
CANCER,NOS
Interventions
Lirilumab
Nivolumab
Ipilimumab
Countries
United States
Canada
France
Italy
Spain
Switzerland
Protocol Section
Identification Module
NCT ID
NCT01714739
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA223-001
Secondary IDs
Not provided
Brief Title
A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors
Official Title
A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jan 2023
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
Oct 7, 2012Actual
Primary Completion Date
Dec 13, 2019Actual
Completion Date
Dec 13, 2019Actual
First Submitted Date
Oct 24, 2012
First Submission Date that Met QC Criteria
Oct 24, 2012
First Posted Date
Oct 26, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2022
Results First Submitted that Met QC Criteria
Jan 17, 2023
Results First Posted Date
Feb 2, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Dec 10, 2020
Certification/Extension First Submitted that Passed QC Review
Dec 10, 2020
Certification/Extension First Posted Date
Dec 14, 2020Actual
Last Update Submitted Date
Jan 17, 2023
Last Update Posted Date
Feb 2, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
CANCER,NOS
Keywords
Not provided
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
337Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1
Experimental
Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
Drug: Lirilumab
Drug: Nivolumab
Part 2 and 3: Cohort Expansion
Experimental
In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
Drug: Lirilumab
Drug: Nivolumab
Part 4: Cohort Expansion
Experimental
Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
Drug: Lirilumab
Drug: Nivolumab
Part 5 and 6
Experimental
Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)
Drug: Lirilumab
Drug: Nivolumab
Drug: Ipilimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Lirilumab
Drug
Specified dose on specified days.
Part 1
Part 2 and 3: Cohort Expansion
Part 4: Cohort Expansion
Part 5 and 6
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5
Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
The Number of Participant Deaths in the Study - Parts 1, 2 and 5
The number of participants who died.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5
Secondary Outcomes
Measure
Description
Time Frame
Disease Control Rate (DCR) - Part 3
Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen
During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
Subjects must have measurable disease
Subject must consent to provide previously collected tumor tissue
Women and men ≥18 years of age with performance status of 0 or 1
At least 4 weeks since any previous treatment for cancer
Exclusion Criteria:
Active or chronic autoimmune diseases
Uncontrolled or significant cardiovascular disease
Chronic hepatitis (except for subjects with hepatocellular carcinoma)
Active infection
Active Central nervous system (CNS) metastases
Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)
Other protocol defined inclusion/exclusion criteria could apply
Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose up to approximately 2.5 years
From first dose up to approximately 2.5 years
Median Duration of Response (mDOR) - Parts 3 and 5
DOR is defined as the time from the date of first response (CR or PR) to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
Median Time to Response (mTTR) - Part 3
TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)
The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5
Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with >= 50% and >= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.
From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)
Overall Survival (OS) - Part 3
Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.
From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)
Progression Free Survival (PFS) - Part 3
PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
Progression Free Survival Rate (PFSR) at 6 Months - Part 3
Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
At 6 months after first dose
Number of Participants With Adverse Events (AEs) - Part 3
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Serious Adverse Events (SAEs) - Part 3
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3
Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
The Number of Participant Deaths in the Study - Part 3
The number of participants who died.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3
Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5
Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.
ADA Positive Participant: Participant with >=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer >= 9-fold for Lirilumab and >= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.
From first dose to 100 days after last dose (up to approximately 126 weeks)
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5
The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show >=1% or >= 5% PD-L1 expression in the tumor cell membrane and negative if they show < 1% or < 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.
PDL1= programmed cell death ligand 1
Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)
Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Half-life (T-HALF) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Clearance Per Time (CLT) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
Ctrough - Parts 1, 2 and 5 (Liri)
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)
Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
Ctrough - Parts 1, 2 and 5 (Nivo)
Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.
Ocala
Florida
34471
United States
University Of Chicago Medical Center
Chicago
Illinois
60637
United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
FG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
FG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
FG004
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
FG005
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
FG006
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
FG0004 subjects
FG00116 subjects
FG00215 subjects
FG003287 subjects
FG0042 subjects
FG0053 subjects
FG00610 subjects
COMPLETED
FG0000 subjects
FG0016 subjects
FG0025 subjects
FG00323 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0004 subjects
FG00110 subjects
FG00210 subjects
FG003264 subjects
FG0042 subjects
FG0053 subjects
FG00610 subjects
Type
Comment
Reasons
Disease progression
FG0003 subjects
FG0015 subjects
FG0025 subjects
FG003204 subjects
FG0041 subjects
FG0053 subjects
FG0065 subjects
Study drug toxicity
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG00315 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Adverse Event unrelated to drug
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG00321 subjects
FG004
Participant request to stop therapy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0036 subjects
FG004
Participant withdrew consent
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0038 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Maximum clinical benefit
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0033 subjects
FG004
Poor/non-comliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
No longer meets study criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
BG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
BG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
BG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
BG004
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
BG005
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
BG006
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG00116
BG00215
BG003287
BG0042
BG0053
BG00610
BG007337
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
BG00053.3± 12.09
BG00158.1± 13.11
BG00258.7± 16.85
BG003
Age, Customized
Age categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
< 65 years old
BG0004
BG00110
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0015
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race/Ethnicity, Customized
Race
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0004
BG00116
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 Adverse Events (AEs) - Parts 1, 2 and 5
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003
Title
Denominators
Categories
Title
Measurements
OG0004
OG00116
OG00215
OG003
Primary
Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Primary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5
Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Primary
The Number of Participant Deaths in the Study - Parts 1, 2 and 5
The number of participants who died.
All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Primary
Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5
Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Parts 1, 2 and 5.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Primary
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose up to approximately 2.5 years
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Disease Control Rate (DCR) - Part 3
Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Number
95% Confidence Interval
Percentage of participants
From first dose up to approximately 2.5 years
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Secondary
Median Duration of Response (mDOR) - Parts 3 and 5
DOR is defined as the time from the date of first response (CR or PR) to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Parts 3 and 5.
Posted
Median
Full Range
weeks
From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Secondary
Median Time to Response (mTTR) - Part 3
TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Part 3.
Posted
Median
Full Range
Weeks
From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Secondary
The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5
Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with >= 50% and >= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.
All treated participants. Pre-specified for data to be collected only in Parts 3 and 5.
Posted
Count of Participants
Participants
From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG002
Part 5: Liri 3 + Nivo 3 + Ipi 1
Secondary
Overall Survival (OS) - Part 3
Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Median
Full Range
Years
From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
Secondary
Progression Free Survival (PFS) - Part 3
PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Median
Full Range
Months
From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Secondary
Progression Free Survival Rate (PFSR) at 6 Months - Part 3
Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
All treated participants in Part 3
Posted
Number
95% Confidence Interval
Percentage of participants
At 6 months after first dose
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Secondary
Number of Participants With Adverse Events (AEs) - Part 3
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
Secondary
Number of Participants With Serious Adverse Events (SAEs) - Part 3
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
Secondary
Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3
Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
Secondary
The Number of Participant Deaths in the Study - Part 3
The number of participants who died.
All treated participants. Pre-specified for data to be collected only in Part 3.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Clinical Laboratory Test Abnormalities - Part 3
Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Part 3.
Posted
Count of Participants
Participants
From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
ID
Title
Description
OG000
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG001
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Secondary
Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5
Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.
ADA Positive Participant: Participant with >=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer >= 9-fold for Lirilumab and >= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.
All participants who receive at least 1 dose of drug and have at least 1 ADA sample available. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Count of Participants
Participants
From first dose to 100 days after last dose (up to approximately 126 weeks)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5
The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show >=1% or >= 5% PD-L1 expression in the tumor cell membrane and negative if they show < 1% or < 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.
PDL1= programmed cell death ligand 1
All treated participants with available archival tumor sample and with pre- and on-treatment biopsies. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Number
Number of participants
Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Secondary
Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
hour*ng/mL
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Median
Full Range
hour
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Secondary
Half-life (T-HALF) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Mean
Standard Deviation
hour
Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Secondary
Clearance Per Time (CLT) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
liter per hour
Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Secondary
Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Ctrough - Parts 1, 2 and 5 (Liri)
Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Secondary
End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)
Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Secondary
Ctrough - Parts 1, 2 and 5 (Nivo)
Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.
ID
Title
Description
OG000
Part 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
Time Frame
Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).
Description
Not provided
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 1/2 Liri 0.1 + Nivo 3
Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
2
4
1
4
4
4
EG001
Part 1/2: Liri 0.3 + Nivo 3
Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
7
16
8
16
16
16
EG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
5
15
9
15
15
15
EG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
219
287
205
287
271
287
EG004
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
1
2
2
2
2
2
EG005
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
3
3
3
3
3
3
EG006
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
5
10
7
10
10
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG00313 affected287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
Bone marrow failure
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lymph node haemorrhage
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Splenic haemorrhage
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Autoimmune pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Salivary gland fistula
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tongue haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Complication associated with device
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Face oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hyperthermia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Localised oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Secretion discharge
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Sudden death
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Ulcer
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hepatic haematoma
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Actinomycosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cellulitis orbital
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Device related infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Infective thrombosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Psoas abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Skin infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tracheitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Device placement issue
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Osteoradionecrosis
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Radiation skin injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Vascular procedure complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
General physical condition abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Platelet count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Feeding disorder
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0021 affected15 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Metastases to spine
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Brain oedema
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Carotid artery aneurysm
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Central nervous system haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Coma
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Device dislocation
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Device occlusion
Product Issues
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Uterine polyp
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0020 affected15 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypercapnia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Immune-mediated pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Laryngeal dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Upper airway obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Arterial rupture
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Embolism
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Shock
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Agranulocytosis
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG0030 affected287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected16 at risk
EG0020 affected15 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0022 affected15 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
External ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0022 affected15 at risk
EG003
Cataract
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Cataract nuclear
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Chorioretinal atrophy
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Chorioretinal disorder
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Diplopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Dry eye
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Eye movement disorder
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Eye pain
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Lagophthalmos
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Meibomian gland dysfunction
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Myopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Ocular discomfort
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Retinal deposits
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Strabismus
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Swelling of eyelid
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Uveitis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Visual impairment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Vitreous detachment
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0023 affected15 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected16 at risk
EG0025 affected15 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Anal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0015 affected16 at risk
EG0024 affected15 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0027 affected15 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0021 affected15 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0013 affected16 at risk
EG0027 affected15 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0012 affected16 at risk
EG0025 affected15 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Catheter site haemorrhage
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0015 affected16 at risk
EG0021 affected15 at risk
EG003
Device related thrombosis
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Early satiety
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Face oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Facial pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG0003 affected4 at risk
EG0016 affected16 at risk
EG0027 affected15 at risk
EG003
Influenza like illness
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0023 affected15 at risk
EG003
Injection site swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Localised oedema
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Mass
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0020 affected15 at risk
EG003
Nodule
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0023 affected15 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0015 affected16 at risk
EG0022 affected15 at risk
EG003
Swelling face
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected16 at risk
EG0021 affected15 at risk
EG003
Xerosis
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Type IV hypersensitivity reaction
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Bacterial vaginosis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Fungal disease carrier
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Ophthalmic herpes zoster
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Pneumonia influenzal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected16 at risk
EG0022 affected15 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0013 affected16 at risk
EG0022 affected15 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Incision site pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0027 affected15 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Post procedural complication
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Amylase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0021 affected15 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0013 affected16 at risk
EG0020 affected15 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0020 affected15 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Blood magnesium increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Blood phosphorus decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Blood pressure increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
CD4 lymphocytes decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Electrocardiogram T wave amplitude decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Heart sounds abnormal
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Intraocular pressure increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Lipase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Prothrombin time ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Troponin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 affected4 at risk
EG0012 affected16 at risk
EG0024 affected15 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0022 affected15 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0015 affected16 at risk
EG0028 affected15 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0023 affected15 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0026 affected15 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 affected4 at risk
EG0011 affected16 at risk
EG0022 affected15 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0022 affected15 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0020 affected15 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0024 affected15 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0023 affected15 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0012 affected16 at risk
EG0024 affected15 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0022 affected15 at risk
EG003
Acrochordon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0020 affected15 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Haemangioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0021 affected15 at risk
EG003
Seborrhoeic keratosis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0011 affected16 at risk
EG0021 affected15 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 affected4 at risk
EG0010 affected16 at risk
EG0020 affected15 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003287
OG00410
Title
Denominators
Categories
Title
Measurements
OG0001
OG0018
OG0029
OG003205
OG0047
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003287
OG00410
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
OG0024
OG00349
OG0045
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003287
OG00410
Title
Denominators
Categories
Title
Measurements
OG0002
OG0017
OG0025
OG003219
OG0045
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003287
OG00410
Title
Denominators
Categories
Absolute Neutrophil Count - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003286
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG003
Absolute Neutrophil Count - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003286
Alanine Amino Transferase (ALT) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Alanine Amino Transferase (ALT) - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Albumin - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003256
Albumin - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003256
Alkaline Phosphatase (ALP) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Alkaline Phosphatase (ALP) - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Amylase, Total - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003274
Amylase, Total - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003274
APTT - Grade 3
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG00325
APTT - Grade 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG00325
Aspartate Aminotransferase (AST) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Aspartate Aminotransferase (AST) - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Bilirubin, Total - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003277
Bilirubin, Total - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003287
Calcium, Corrected - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00361
Calcium, Corrected - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00361
Calcium, Ionized - Grade 3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
Calcium, Ionized - Grade 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0032
Calcium, Total - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003279
Calcium, Total - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003279
Creatine Kinase (CK) - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatine Kinase (CK) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Creatinine - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
Creatinine - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
Fibrinogen - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00347
Fibrinogen - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00347
G-Glutamyl Transferase (GGT) - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
G-Glutamyl Transferase (GGT) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Glucose, Fasting Serum - Grade 3
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00371
Glucose, Fasting Serum - Grade 4
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00371
Glucose, Serum - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Glucose, Serum - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0021
ParticipantsOG0032
Hemoglobin - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Hemoglobin - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Leukocytes - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Leukocytes - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Lipase, Total (Colorimetric Assay) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003286
Lipase, Total (Colorimetric Assay) - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003275
Lipase, Total (Turbidimetric Assay) - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Lipase, Total (Turbidimetric Assay) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0035
Lymphocytes (Absolute) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Lymphocytes (Absolute) - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Magnesium, Serum - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003276
Magnesium, Serum - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003276
Neutrophils (Absolute) - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Neutrophils (Absolute) - Grade 4
ParticipantsOG0000
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
pH, Arterial Blood - Grade 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003285
pH, Arterial Blood - Grade 4
ParticipantsOG0004
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003285
Phosphorus, Inorganic - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003269
Phosphorus, Inorganic - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003269
Platelet Count - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Platelet Count - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003281
Potassium, Serum - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
Potassium, Serum - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
Sodium Serum - Grade 3
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
Sodium Serum - Grade 4
ParticipantsOG0004
ParticipantsOG00116
ParticipantsOG00215
ParticipantsOG003278
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 3: PBO + Nivo 240
Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG005
Part 3: Liri 240 + Nivo 240
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG006
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00116
OG00215
OG003287
OG0042
OG0053
OG00610
Title
Denominators
Categories
Title
Measurements
OG00025.0(0.6 to 80.6)
OG00137.5(15.2 to 64.6)
OG00240.0(16.3 to 67.7)
OG00314.6(10.8 to 19.3)
OG00450.0(1.3 to 98.7)
OG0050(0.0 to 70.8)
OG0060(0.0 to 30.8)
Units
Counts
Participants
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG00050.0(1.3 to 98.7)
OG00133.3(0.8 to 90.6)
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
OG002
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0001
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG000NA(40.0 to 40.0)Insufficient number of participants with events
Participants
OG0001
OG0010
Title
Denominators
Categories
Title
Measurements
OG0008.10(8.1 to 8.1)
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0002
OG0013
OG00210
Title
Denominators
Categories
WITH >=50% TUMOR REDUCTION
Title
Measurements
OG0001
OG0012
OG0020
WITH >=80% TUMOR REDUCTION
Title
Measurements
OG0000
OG0011
OG0020
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG000NA(0.2 to 1.2)Time point at which % of survivors drops below 50% has not been reached due to insufficient number of events and/or follow up
OG0010.3(0.1 to 0.8)
Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.
Units
Counts
Participants
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG000NA(1.1 to 11.0)Insufficient number of events
OG0011.6(1.1 to 7.4)
Participants
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG00050.0(0.6 to 91.0)
OG00133.3(0.9 to 77.4)
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG0002
OG0013
OG0002
OG0013
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
2
OG0013
Title
Denominators
Categories
Title
Measurements
OG0001
OG0013
Units
Counts
Participants
OG0002
OG0013
Title
Denominators
Categories
Absolute Neutrophil Count - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG0010
Absolute Neutrophil Count - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Alanine Amino Transferase (ALT) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Alanine Amino Transferase (ALT) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Albumin - Grade 3
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000
OG001
Albumin - Grade 4
ParticipantsOG0001
ParticipantsOG0011
Title
Measurements
OG0000
OG001
Alkaline Phosphatase (ALP) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Alkaline Phosphatase (ALP) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Amylase, Total - Grade 3
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG0001
OG001
Amylase, Total - Grade 4
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG0000
OG001
APTT - Grade 3
ParticipantsOG0000
ParticipantsOG0010
APTT - Grade 4
ParticipantsOG0000
ParticipantsOG0010
Aspartate Aminotransferase (AST) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Aspartate Aminotransferase (AST) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Bilirubin, Total - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Bilirubin, Total - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Calcium, Corrected - Grade 3
ParticipantsOG0000
ParticipantsOG0012
Title
Measurements
OG0010
Calcium, Corrected - Grade 4
ParticipantsOG0000
ParticipantsOG0012
Title
Measurements
OG0010
Calcium, Ionized - Grade 3
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG0000
Calcium, Ionized - Grade 4
ParticipantsOG0001
ParticipantsOG0010
Title
Measurements
OG0000
Calcium, Total - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Calcium, Total - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Creatine Kinase (CK) - Grade 3
ParticipantsOG0000
ParticipantsOG0010
Creatine Kinase (CK) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
Creatinine - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Creatinine - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Fibrinogen - Grade 3
ParticipantsOG0000
ParticipantsOG0010
Fibrinogen - Grade 4
ParticipantsOG0000
ParticipantsOG0010
G-Glutamyl Transferase (GGT) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
G-Glutamyl Transferase (GGT) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
Glucose, Fasting Serum - Grade 3
ParticipantsOG0000
ParticipantsOG0010
Glucose, Fasting Serum - Grade 4
ParticipantsOG0002
ParticipantsOG0012
Title
Measurements
OG0000
OG001
Glucose, Serum - Grade 3
ParticipantsOG0001
ParticipantsOG0012
Title
Measurements
OG0000
OG001
Glucose, Serum - Grade 4
ParticipantsOG0001
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Hemoglobin - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Hemoglobin - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Leukocytes - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Leukocytes - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Lipase, Total (Colorimetric Assay) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Lipase, Total (Colorimetric Assay) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0001
OG001
Lipase, Total (Turbidimetric Assay) - Grade 3
ParticipantsOG0000
ParticipantsOG0010
Lipase, Total (Turbidimetric Assay) - Grade 4
ParticipantsOG0000
ParticipantsOG0010
Lymphocytes (Absolute) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Lymphocytes (Absolute) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0001
OG001
Magnesium, Serum - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Magnesium, Serum - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Neutrophils (Absolute) - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Neutrophils (Absolute) - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
pH, Arterial Blood - Grade 3
ParticipantsOG0000
ParticipantsOG0010
pH, Arterial Blood - Grade 4
ParticipantsOG0000
ParticipantsOG0010
Phosphorus, Inorganic - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Phosphorus, Inorganic - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Platelet Count - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Platelet Count - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Potassium, Serum - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Potassium, Serum - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Sodium Serum - Grade 3
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
Sodium Serum - Grade 4
ParticipantsOG0002
ParticipantsOG0013
Title
Measurements
OG0000
OG001
OG002
Part 1/2: Liri 1 + Nivo 3
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00115
OG00213
OG003255
OG0044
Title
Denominators
Categories
Baseline ADA Positive - Liri
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG003254
ParticipantsOG0044
Title
Measurements
OG0000
OG0012
OG0020
OG003
ADA Positive - Liri
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG003254
ADA Negative - Liri
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG00210
ParticipantsOG003254
Baseline ADA Positive - Nivo
ParticipantsOG0004
ParticipantsOG00115
ParticipantsOG00213
ParticipantsOG003255
ADA Positive - Nivo
ParticipantsOG0004
ParticipantsOG00115
ParticipantsOG00213
ParticipantsOG003255
ADA Negative - Nivo
ParticipantsOG0004
ParticipantsOG00115
ParticipantsOG00213
ParticipantsOG003255
Baseline ADA Positive - Ipi
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ADA Positive - Ipi
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ADA Negative - Ipi
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0003
OG00111
OG00213
OG003231
OG0041
Title
Denominators
Categories
PD-L1 1 percent - positive
Title
Measurements
OG0002
OG0015
OG0029
OG003127
OG0041
PD-L1 1 percent - negative
Title
Measurements
OG0001
OG0016
OG0024
OG003
PD-L1 5 percent - positive
Title
Measurements
OG0002
OG0014
OG0024
OG003
PD-L1 5 percent - negative
Title
Measurements
OG0001
OG0017
OG0029
OG003
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00113
OG00211
OG003249
OG0042
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003249
ParticipantsOG0042
Title
Measurements
OG0002223.10± NANA = Geometric CV not applicable; %CV = 27
OG0016509.35± NANA = Geometric CV not applicable; %CV = 27
OG00222250.96± NANA = Geometric CV not applicable; %CV = 29
OG003
Cycle 2
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG003111
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00113
OG00211
OG003249
OG0042
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003249
ParticipantsOG0042
Title
Measurements
OG000360903.09± NANA = Geometric CV not applicable; %CV = 23
OG001734836.53± NANA = Geometric CV not applicable; %CV = 45
OG0024462883.03± NANA = Geometric CV not applicable; %CV = 35
OG003
Cycle 2
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG003111
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00112
OG00211
OG003209
OG0041
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003209
ParticipantsOG0041
Title
Measurements
OG000366418.73± NANA = Geometric CV not applicable; %CV = 21
OG0011155363.50± NANA = Geometric CV not applicable; %CV = 33
OG0024462883.03± NANA = Geometric CV not applicable; %CV = 35
OG003
Cycle 2
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG00210
ParticipantsOG00374
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00113
OG00211
OG003249
OG0042
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003249
ParticipantsOG0042
Title
Measurements
OG0001.13(1.0 to 1.3)
OG0011.05(0.8 to 21.7)
OG0021.07(1.0 to 1.6)
OG003
Cycle 2
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG003111
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0003
OG0017
OG0027
OG00394
OG0040
Title
Denominators
Categories
Title
Measurements
OG000383.96± 235.421
OG001273.89± 234.588
OG002515.07± 361.525
OG003281.31± 237.236
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0003
OG0016
OG00210
OG00375
OG0040
Title
Denominators
Categories
Title
Measurements
OG0000.01± NANA = Geometric CV not applicable; %CV = 22
OG0010.01± NANA = Geometric CV not applicable; %CV = 38
OG0020.01± NANA = Geometric CV not applicable; %CV = 35
OG0030.01± NANA = Geometric CV not applicable; %CV = 30
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00112
OG00211
OG003209
OG0041
Title
Denominators
Categories
Cycle 1
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003209
ParticipantsOG0041
Title
Measurements
OG00087.62± NANA = Geometric CV not applicable; %CV = 77
OG001521.28± NANA = Geometric CV not applicable; %CV = 60
OG0022572.90± NANA = Geometric CV not applicable; %CV = 47
OG003
Cycle 2
ParticipantsOG0003
ParticipantsOG0016
ParticipantsOG00210
ParticipantsOG00374
Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Title
Denominators
Categories
Cycle 1
Cycle 2
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
Title
Denominators
Categories
Cycle 1
Cycle 2
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00113
OG00211
OG003249
OG0042
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG00113
ParticipantsOG00211
ParticipantsOG003249
ParticipantsOG0042
Title
Measurements
OG0002223.10± NANA = Geometric CV not applicable; %CV = 27
OG0016434.65± NANA = Geometric CV not applicable; %CV = 28
OG00222250.96± NANA = Geometric CV not applicable; %CV = 29
OG003
Cycle 2 Day 29
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG003110
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0003
OG00112
OG00211
OG003200
OG0041
Title
Denominators
Categories
Cycle 1 Day 29
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003200
ParticipantsOG0041
Title
Measurements
OG000192.29± NANA = Geometric CV not applicable; %CV = 42
OG001521.28± NANA = Geometric CV not applicable; %CV = 60
OG0022572.90± NANA = Geometric CV not applicable; %CV = 47
OG003
Cycle 2 Day 29
ParticipantsOG0002
ParticipantsOG0019
ParticipantsOG00211
ParticipantsOG003110
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00115
OG00212
OG003253
OG0046
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG00115
ParticipantsOG00211
ParticipantsOG003253
ParticipantsOG0046
Title
Measurements
OG00063.16± NANA = Geometric CV not applicable; %CV = 31
OG00166.33± NANA = Geometric CV not applicable; %CV = 16
OG00266.16± NANA = Geometric CV not applicable; %CV = 24
OG003
Cycle 2 Day 29
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00212
ParticipantsOG003111
OG003
Part 1/2: Liri 3 + Nivo 3
Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.
OG004
Part 5: Liri 3 + Nivo 3 + Ipi 1
Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease
Units
Counts
Participants
OG0004
OG00114
OG00215
OG003244
OG0044
Title
Denominators
Categories
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG00114
ParticipantsOG00215
ParticipantsOG003244
ParticipantsOG0044
Title
Measurements
OG00019.15± NANA = Geometric CV not applicable; %CV = 16
OG00120.14± NANA = Geometric CV not applicable; %CV = 24
OG00221.36± NANA = Geometric CV not applicable; %CV = 24
OG003
Cycle 2 Day 29
ParticipantsOG0003
ParticipantsOG0019
ParticipantsOG00213
ParticipantsOG003123
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
7 affected
287 at risk
EG0040 affected2 at risk
EG0051 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
9 affected
287 at risk
EG0040 affected2 at risk
EG0051 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
14 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0041 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
13 affected
287 at risk
EG0040 affected2 at risk
EG0051 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
13 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
13 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
8 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
109 affected
287 at risk
EG0041 affected2 at risk
EG0052 affected3 at risk
EG0062 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0041 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
24 affected
287 at risk
EG0041 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0062 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
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287 at risk
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EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
11 affected
287 at risk
EG0040 affected2 at risk
EG0051 affected3 at risk
EG0060 affected10 at risk
10 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
7 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
12 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
17 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
6 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
48 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0063 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
42 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0062 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
13 affected
287 at risk
EG0041 affected2 at risk
EG0050 affected3 at risk
EG0062 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
5 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0061 affected10 at risk
1 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
4 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
3 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
14 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
19 affected
287 at risk
EG0040 affected2 at risk
EG0051 affected3 at risk
EG0061 affected10 at risk
2 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
0 affected
287 at risk
EG0040 affected2 at risk
EG0050 affected3 at risk
EG0060 affected10 at risk
2
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0042
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG0042
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0020
OG0036
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0048
Title
Measurements
OG0000
OG0010
OG0020
OG0038
OG0040
ParticipantsOG0048
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
Participants
OG004
1
Title
Measurements
OG0010
OG0020
OG0030
OG0040
Participants
OG004
1
Title
Measurements
OG0010
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0020
OG0034
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0042
Title
Measurements
OG0030
OG0040
ParticipantsOG0042
Title
Measurements
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0010
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0010
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0036
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0034
OG0040
ParticipantsOG0040
Title
Measurements
OG0030
OG0040
ParticipantsOG0040
Title
Measurements
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0041
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0030
OG0040
ParticipantsOG0041
Title
Measurements
OG0030
OG0040
ParticipantsOG0040
Title
Measurements
OG0030
ParticipantsOG0040
Title
Measurements
OG0030
ParticipantsOG0042
Title
Measurements
OG0010
OG0031
OG0040
ParticipantsOG0042
Title
Measurements
OG0010
OG0030
OG0040
ParticipantsOG0040
Title
Measurements
OG0020
OG0030
ParticipantsOG0040
Title
Measurements
OG0020
OG0030
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0021
OG00324
OG0041
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0020
OG0033
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0033
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0012
OG0022
OG00318
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0037
OG0040
ParticipantsOG0040
Title
Measurements
OG0030
ParticipantsOG0040
Title
Measurements
OG0030
ParticipantsOG00410
Title
Measurements
OG0000
OG0013
OG0024
OG00364
OG0044
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0039
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0032
OG0040
ParticipantsOG00410
Title
Measurements
OG0011
OG0020
OG0030
OG0040
ParticipantsOG0040
Title
Measurements
OG0030
ParticipantsOG0040
Title
Measurements
OG0000
OG0030
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0023
OG00310
OG0041
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0036
OG0040
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0033
OG0041
ParticipantsOG00410
Title
Measurements
OG0000
OG0011
OG0021
OG00326
OG0041
ParticipantsOG00410
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
21
OG0041
ParticipantsOG0044
Title
Measurements
OG0001
OG0011
OG0020
OG00320
OG0040
ParticipantsOG0044
Title
Measurements
OG0003
OG00110
OG00210
OG003234
OG0044
ParticipantsOG0043
Title
Measurements
OG0000
OG0011
OG0023
OG00314
OG0041
ParticipantsOG0043
Title
Measurements
OG0000
OG0011
OG0020
OG00343
OG0040
ParticipantsOG0043
Title
Measurements
OG0004
OG00114
OG00213
OG003212
OG0043
ParticipantsOG0043
Title
Measurements
OG0041
ParticipantsOG0043
Title
Measurements
OG0040
ParticipantsOG0043
Title
Measurements
OG0043
104
OG0040
77
OG0040
154
OG0041
52034.18
± NA
NA = Geometric CV not applicable; %CV = 33
OG00465333.91± NANA = Geometric CV not applicable; %CV = 3
Participants
OG004
1
Title
Measurements
OG0002277.39± NANA = Geometric CV not applicable; %CV = 6
OG0017286.95± NANA = Geometric CV not applicable; %CV = 24
OG00225623.89± NANA = Geometric CV not applicable; %CV = 20
OG00369224.70± NANA = Geometric CV not applicable; %CV = 26
OG00481600.00± NANA = only 1 participant
9647500.52
± NA
NA = Geometric CV not applicable; %CV = 37
OG0048819119.61± NANA = Geometric CV not applicable; %CV = 29
Participants
OG004
1
Title
Measurements
OG000569516.79± NANA = Geometric CV not applicable; %CV = 26
OG0011367259.80± NANA = Geometric CV not applicable; %CV = 67
OG0026547184.03± NANA = Geometric CV not applicable; %CV = 37
OG00311731186.91± NANA = Geometric CV not applicable; %CV = 51
OG0049958714.89± NANA = not applicable, only 1 participant
11418017.10
± NA
NA = Geometric CV not applicable; %CV = 28
OG00410843715.48± NANA = not applicable, only 1 participant
Participants
OG004
0
Title
Measurements
OG000569516.79± NANA = Geometric CV not applicable; %CV = 26
OG0011726615.52± NANA = Geometric CV not applicable; %CV = 44
OG0026712959.58± NANA = Geometric CV not applicable; %CV = 31
OG00318504162.18± NANA = Geometric CV not applicable; %CV = 28
1.22
(0.1 to 161.3)
OG0041.03(1.0 to 1.1)
Participants
OG004
1
Title
Measurements
OG0001.08(1.0 to 1.5)
OG0011.02(1.0 to 1.6)
OG0021.13(0.9 to 25.5)
OG0031.18(0.8 to 168.1)
OG0041.33(1.33 to 1.33)
6195.04
± NA
NA = Geometric CV not applicable; %CV = 45
OG0045190.00± NANA = not applicable, only 1 participant
Participants
OG004
0
Title
Measurements
OG000358.55± NANA = Geometric CV not applicable; %CV = 68
OG0011180.39± NANA = Geometric CV not applicable; %CV = 65
OG0024827.27± NANA = Geometric CV not applicable; %CV = 32
OG00311392.89± NANA = Geometric CV not applicable; %CV = 45
45163.87
± NA
NA = Geometric CV not applicable; %CV = 38
OG00465333.91± NANA = Geometric CV not applicable; %CV = 3
ParticipantsOG0041
Title
Measurements
OG0002277.39± NANA = Geometric CV not applicable; %CV = 6
OG0017286.95± NANA = Geometric CV not applicable; %CV = 24
OG00225185.06± NANA = Geometric CV not applicable; %CV = 20
OG00365874.20± NANA = Geometric CV not applicable; %CV = 30
OG00481600.00± NANA = not applicable, only 1 participant
6195.08
± NA
NA = Geometric CV not applicable; %CV = 45
OG0045190.00± NANA = not applicable, only 1 participant
ParticipantsOG0041
Title
Measurements
OG000327.50± NANA = Geometric CV not applicable; %CV = 85
OG0011069.84± NANA = Geometric CV not applicable; %CV = 63
OG0024592.95± NANA = Geometric CV not applicable; %CV = 32
OG00310865.91± NANA = Geometric CV not applicable; %CV = 45
OG00419100.00± NANA = not applicable, only 1 participant
52.48
± NA
NA = Geometric CV not applicable; %CV = 25
OG00444.75± NANA = Geometric CV not applicable; %CV = 15
ParticipantsOG0042
Title
Measurements
OG000104.47± NANA = Geometric CV not applicable; %CV = 16
OG001114.89± NANA = Geometric CV not applicable; %CV = 28
OG002116.08± NANA = Geometric CV not applicable; %CV = 17
OG00399.75± NANA = Geometric CV not applicable; %CV = 25
OG004115.37± NANA = Geometric CV not applicable; %CV = 7
15.81
± NA
NA = Geometric CV not applicable; %CV = 32
OG00417.30± NANA = Geometric CV not applicable; %CV = 19
ParticipantsOG0042
Title
Measurements
OG00055.67± NANA = Geometric CV not applicable; %CV = 42
OG00162.18± NANA = Geometric CV not applicable; %CV = 38
OG00271.31± NANA = Geometric CV not applicable; %CV = 21
OG00350.07± NANA = Geometric CV not applicable; %CV = 32
OG00462.62± NANA = Geometric CV not applicable; %CV = 17