Study of Favezelimab (MK-4280) as Monotherapy and in Comb... | NCT02720068 | Trialant
NCT02720068
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
May 30, 2025Actual
Enrollment
481Actual
Phase
Phase 1
Conditions
Neoplasms
Interventions
Favezelimab
Pembrolizumab
Oxaliplatin
Irinotecan
Leucovorin (Calcium Folinate)
Fluorouracil [5-FU]
Favezelimab/Pembrolizumab
Lenvatinib
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT02720068
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
4280-001
Secondary IDs
ID
Type
Description
Link
MK-4280-001
Other Identifier
Merck Protocol Number
183971
Other Identifier
JAPIC-CTI
2017-001464-38
EudraCT Number
Brief Title
Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001)
Official Title
A Phase 1 Trial of MK-4280 as Monotherapy and in Combination With Pembrolizumab With or Without Chemotherapy or Lenvatinib (E7080/MK-7902) in Subjects With Advanced Solid Tumors
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
May 2025
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
May 2, 2016Actual
Primary Completion Date
Mar 15, 2024Actual
Completion Date
Mar 15, 2024Actual
First Submitted Date
Mar 22, 2016
First Submission Date that Met QC Criteria
Mar 22, 2016
First Posted Date
Mar 25, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 4, 2025
Results First Submitted that Met QC Criteria
May 28, 2025
Results First Posted Date
May 30, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 28, 2025
Last Update Posted Date
May 30, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
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
This is a safety and pharmacokinetics study of favezelimab as monotherapy and in combination with pembrolizumab AND favezelimab/pembrolizumab as monotherapy in adults with metastatic solid tumors for which there is no available therapy which may convey clinical benefit. Part A of this study is a dose escalation design in which participants receive favezelimab as monotherapy or favezelimab in combination with pembrolizumab. Part B is a dose confirmation design to estimate the recommended Phase 2 dose (RP2D), as determined by dose-limiting toxicity, for favezelimab in combination with pembrolizumab or pembrolizumab and lenvatinib in participants with advanced solid tumors. Part B will also assess the efficacy of favezelimab as monotherapy; favezelimab in combination with pembrolizumab with and without chemotherapy; favezelimab in combination with pembrolizumab and lenvatinib; and favezelimab/pembrolizumab as monotherapy in expansion cohorts. Participants who have completed the initial course of treatment and have investigator-determined progressive disease may be eligible for a second course of an additional 17 cycles of study treatment.
Detailed Description
All participants who completed the first course were eligible for second course treatment after Sponsor consultation if there was investigator-determined progressive disease after initial treatment had been been completed.
Conditions Module
Conditions
Neoplasms
Keywords
Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lymphocyte-activation gene 3 (LAG3, LAG-3, CD223)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
481Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Favezelimab 7 mg Monotherapy
Experimental
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
Biological: Favezelimab
Part A: Favezelimab 21 mg Monotherapy
Experimental
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
Biological: Favezelimab
Part A: Favezelimab 70 mg Monotherapy
Experimental
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
Biological: Favezelimab
Part A: Favezelimab 210 mg Monotherapy
Experimental
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
Biological: Favezelimab
Part A: Favezelimab 700 mg Monotherapy
Experimental
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
Biological: Favezelimab
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Favezelimab
Biological
IV infusion
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Part A: Favezelimab 21 mg Monotherapy
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were assessed during the first cycle (21 days) & were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for >1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.
Up to 21 days (Cycle 1)
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
Up to approximately 31.3 months
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
Up to approximately 28.3 months
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) for Part B Participants
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Part A and Part B: Has histologically or cytologically-confirmed metastatic solid tumor.
Has measurable disease by immune-related Response Evaluation Criteria in Solid Tumors (irRECIST) 1.1 criteria.
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Demonstrates adequate organ function.
If female, is not pregnant or breastfeeding, and if of child-bearing potential, is willing to use an adequate method of contraception for the course of the study and for at least 180 days after the last dose of chemotherapy, 120 days after the last dose of pembrolizumab or favezelimab, or 30 days after the last dose of lenvatinib, whichever occurs last.
If male with a female partner(s) of child-bearing potential, both must agree to use an adequate method of contraception starting with the first dose of study drug through 95 days after the last dose of study drug.
Exclusion Criteria:
Has had chemotherapy, radiation or biological cancer therapy within 4 weeks prior to the first dose of study drug, or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 or 1 from the AEs due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related [ir]AEs).
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.
Has received previous treatment with another agent targeting the lymphocyte-activation gene 3 (LAG-3) receptor.
Has received previous treatment with an immunomodulatory therapy (e.g., anti-programmed cell death-1/anti-programmed cell death-ligand 1 [anti-PD-1/anti-PD-L1] or cytotoxic T-lymphocyte-associated protein 4 [CTLA 4] agent) and was discontinued from that therapy due to a Grade 3 or higher irAE.
Is expected to require any other form of antineoplastic therapy while on study.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy in excess of replacement doses, or on any other form of immunosuppressive medication.
Has a history of a previous, additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Time frame exceptions include successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer, or other in situ cancers.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has had a severe hypersensitivity reaction to treatment with another monoclonal antibody.
Has an active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy.
Has an active infection requiring therapy.
Has history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Has had a prior stem cell or bone marrow transplant.
Has a known history of or screens positive for Human Immunodeficiency Virus (HIV), active chronic or acute Hepatitis B or Hepatitis C.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Is a regular user as determined by investigator judgement (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol), at the time of signing informed consent.
Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
Has clinically significant heart disease that affects normal activities.
Has received a live-virus vaccine within 30 days of planned start of study drug. Seasonal flu vaccines that do not contain live virus are permitted.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Not provided
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Background
Study of Favezelimab (MK-4280) as Monotherapy and in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy or Lenvatinib (MK-7902) AND Favezelimab/Pembrolizumab (MK-4280A) as Monotherapy in Adults With Advanced Solid Tumors (MK-4280-001) - Full Text View - ClinicalTrials.gov
Garralda E, Sukari A, Lakhani NJ, Patnaik A, Lou Y, Im SA, Golan T, Geva R, Wermke M, de Miguel M, Palcza J, Jha S, Chaney M, Abraham AK, Healy J, Falchook GS. A first-in-human study of the anti-LAG-3 antibody favezelimab plus pembrolizumab in previously treated, advanced microsatellite stable colorectal cancer. ESMO Open. 2022 Dec;7(6):100639. doi: 10.1016/j.esmoop.2022.100639. Epub 2022 Dec 6.
One participant received 2 randomization numbers due to an erroneous initial randomization, but is only counted once in Participant Flow due to the rapid correction and drug administration only happening after the correction.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
FG001
Part A: Favezelimab 21 mg Monotherapy
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Dec 1, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
China
Germany
Israel
Japan
Poland
South Korea
Spain
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Participants were allocated to arms in a non-random fashion, except in the case of those with gastric cancer enrolled in Part B, who were randomized 1:1 between Arm 2A and Arm 2B (favezelimab 200 mg and 800 mg, respectively). Part B initiated after determination of a favezelimab recommended phase 2 dose (RP2D) from Part A.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Biological: Favezelimab
Biological: Pembrolizumab
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Experimental
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Biological: Favezelimab
Biological: Pembrolizumab
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Experimental
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Biological: Favezelimab
Biological: Pembrolizumab
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Experimental
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Biological: Favezelimab
Biological: Pembrolizumab
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Experimental
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Biological: Favezelimab
Biological: Pembrolizumab
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Experimental
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Biological: Favezelimab
Biological: Pembrolizumab
Drug: Irinotecan
Drug: Leucovorin (Calcium Folinate)
Drug: Fluorouracil [5-FU]
Part B: MK-4280A (Arm 5)
Experimental
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
Maximum Serum Concentration (Cmax) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
AUC0-inf of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
AUC0-21 Days of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
Cmax of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
Predose Serum Concentration of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.
Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
AUC0-inf of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
AUC0-21 Days of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
Cmax of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
FG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
FG003
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
FG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
FG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
FG014
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG01021 subjects
FG011206 subjects
FG01240 subjects
FG01341 subjects
FG01459 subjects
FG01520 subjects
FG01621 subjects
FG01740 subjects
Treated
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG01020 subjects
FG011205 subjects
FG01240 subjects
FG01341 subjects
FG01458 subjects
FG01520 subjects
FG01620 subjects
FG01740 subjects
Switched Over to Favezelimab + Pembrolizumab
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0109 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Received Second Course of Treatment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0023 subjects
FG0033 subjects
FG0043 subjects
FG0053 subjects
FG0063 subjects
FG0073 subjects
FG0083 subjects
FG0093 subjects
FG01021 subjects
FG011206 subjects
FG01240 subjects
FG01341 subjects
FG01459 subjects
FG01520 subjects
FG01621 subjects
FG01740 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Death
FG0001 subjects
FG0013 subjects
FG0022 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Progressive Disease
FG0002 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
BG001
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
BG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
BG003
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
BG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
BG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
BG014
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0023
BG0033
BG0043
BG0053
BG0063
BG0073
BG0083
BG0093
BG01021
BG011206
BG01240
BG01341
BG01459
BG01520
BG01621
BG01740
BG018481
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
BG00056.3± 15.5
BG00159.3± 10.1
BG00268.7± 15.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced a Dose-Limiting Toxicity (DLT)
DLTs were assessed during the first cycle (21 days) & were defined as: Grade (Gr) 4 nonhematologic toxicity; Gr 4 hematologic toxicity lasting ≥7 days, except Gr 4 thrombocytopenia of any duration or Gr 3 thrombocytopenia associated with bleeding; Gr 3 nonhematologic toxicity lasting ≥3 days despite optimal supportive care (with exceptions); Gr 3 or 4 nonhematologic lab abnormality (if medical intervention was required, lead to hospitalization, or persisted for >1 week); Gr 3 or 4 febrile neutropenia; any drug-related AE that caused the participant to discontinue treatment during Cycle 1; Grade 5 toxicity; Any treatment-related toxicity that causes ≥2-week delay in initiation of Cycle 2.
All participants who received ≥1 dose of study treatment prior to determination of maximum tolerated dose, and were observed for safety for 21 days after their first dose of assigned treatment or experienced a DLT prior to 21 days after their first dose of assigned treatment.
Posted
Count of Participants
Participants
Up to 21 days (Cycle 1)
ID
Title
Description
OG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Units
Counts
Participants
OG0003
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Number of Participants Who Experienced an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who experienced an AE is presented.
All participants who received ≥1 dose of study treatment
Posted
Count of Participants
Participants
Up to approximately 31.3 months
ID
Title
Description
OG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
Primary
Number of Participants Who Discontinued Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment. The number of participants who discontinued study treatment due to an AE is presented.
All participants who received ≥1 dose of study treatment
Posted
Count of Participants
Participants
Up to approximately 28.3 months
ID
Title
Description
OG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 210 mg Monotherapy
Secondary
Objective Response Rate (ORR) for Part B Participants
ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experienced a CR or PR is presented.
All participants enrolled in Part B with a baseline scan with measurable disease by investigator assessment, who received ≥1 dose of study treatment
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 92 months
ID
Title
Description
OG000
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
OG001
Colorectal Cancer Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)
Participants with colorectal cancer received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG002
HNSCC Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)
Secondary
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Favezelimab 7 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Pooled Favezelimab 21 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Secondary
Area Under the Curve From Time 0 to 21 Days (AUC0-21 Days) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Favezelimab 7 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Pooled Favezelimab 21 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Secondary
Maximum Serum Concentration (Cmax) of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the Cmax of favezelimab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Favezelimab 7 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Pooled Favezelimab 21 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG002
Secondary
AUC0-inf of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Pembrolizumab 200 mg
This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).
OG001
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Secondary
AUC0-21 Days of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Pembrolizumab 200 mg
This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).
OG001
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Secondary
Cmax of Pembrolizumab
Blood for serum samples was collected at pre-specified time points to determine the Cmax of pembrolizumab. In addition to time points listed in Time Frame, participants enrolled in mainland China also had samples drawn predose on Day 1 of Cycle 5 and postdose on Day 2 of Cycles 4 and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
μg/mL
Predose, 2 hours post start of infusion, and post infusion on Day 1 of cycles 1-4 and 8; Day 2 postdose in cycle 1; Days 8 and 15 in cycles 2, 4, and 8; and at the discontinuation and safety follow-up visit if performed prior to the end of Cycle 8
ID
Title
Description
OG000
Pooled Pembrolizumab 200 mg
This arm is a protocol-specified pooled arm of all participants who received pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with favezelimab (MK-4280A).
OG001
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Secondary
Predose Serum Concentration of Favezelimab
Blood for serum samples was collected at pre-specified time points to determine the predose serum concentration of favezelimab, which is presented.
All participants who complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Median
Full Range
μg/mL
Predose on Day 1 of cycles 1-4, 6, and 8. Per protocol, different arms had different sampling schedules and therefore were not analyzed for all cycles.
ID
Title
Description
OG000
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG002
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Secondary
AUC0-inf of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the AUC0-inf of lenvatinib.
All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ng/mL
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Units
Counts
Participants
OG000
Secondary
AUC0-21 Days of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the AUC0-21 Days of lenvatinib.
All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
Day*ng/mL
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Units
Counts
Participants
OG000
Secondary
Cmax of Lenvatinib
Blood for serum samples was collected at pre-specified time points to determine the Cmax of lenvatinib.
All participants who received ≥1 dose of lenvatinib and complied with the protocol sufficiently to ensure that generated data likely exhibiting the effects of treatment, according to the underlying scientific model
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Up to 4 hours postdose, and between 6-10 hours postdose on Cycle 1 Day 1; Predose and between 2-12 hours postdose on Cycle 1 Day 15; Predose, between 0.5-4 hours postdose, and between 6-10 hours postdose on Cycle 2 Day 1
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Units
Counts
Participants
OG000
Time Frame
Up to approximately 92 months
Description
AEs include all treated participants. Mortality includes all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless hospitalization/death resulted, so "Neoplasm progression", "Malignant neoplasm progression" & "Disease progression" without hospitalization/death are excluded.
Participants who received 2nd course/switch-over have AEs and mortality counted only in the arm corresponding to the latest treatment they received prior to the event
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 A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
3
3
1
3
3
3
EG001
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
4
6
2
6
5
6
EG002
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
3
3
0
3
3
3
EG003
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
1
3
1
3
3
3
EG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
2
3
1
3
3
3
EG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
1
3
1
3
3
3
EG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
2
3
0
3
3
3
EG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
2
3
2
3
3
3
EG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
3
3
2
3
3
3
EG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
2
3
2
3
3
3
EG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
36
41
12
41
40
41
EG014
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
28
40
23
40
40
40
EG018
Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)
Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
9
9
1
9
7
9
EG019
Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)
One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
0
1
0
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0113 events3 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diverticular perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastric stenosis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastritis haemorrhagic
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal perforation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Death
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Meningitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscle abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pseudomonas bronchitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal stoma complication
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Seroma
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Stoma prolapse
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fulminant type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cerebral artery embolism
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Generalised tonic-clonic seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Completed suicide
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ureteric stenosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Bronchial hyperreactivity
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal granuloma
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Laryngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected3 at risk
EG0041 events1 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected20 at risk
EG01149 events42 affected205 at risk
EG01213 events8 affected40 at risk
EG0134 events4 affected41 at risk
EG01412 events9 affected58 at risk
EG0152 events2 affected20 at risk
EG0164 events3 affected20 at risk
EG0173 events3 affected40 at risk
EG0182 events1 affected9 at risk
EG0190 events0 affected1 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cushingoid
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vision blurred
Eye disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oral pain
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Asthenia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Chills
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Face oedema
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 27.0
Systematic Assessment
EG0003 events3 affected3 at risk
EG0012 events2 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Temperature intolerance
General disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Mastitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Amylase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Carcinoembryonic antigen increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lipase increased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Weight decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0022 events1 affected3 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Ophthalmic migraine
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Libido decreased
Psychiatric disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oedema genital
Reproductive system and breast disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0022 events2 affected3 at risk
EG003
Diaphragmalgia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Paranasal sinus hypersecretion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Milia
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected3 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Sensitive skin
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Diastolic hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.0
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
OG016
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
3
OG0043
OG0053
OG0063
OG0073
OG0083
OG0093
OG01019
OG011198
OG01238
OG01338
OG01420
OG01520
OG01638
OG01739
0
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0111
OG0120
OG0131
OG0140
OG0151
OG0160
OG0173
OG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. One participant received a second course for up to 17 cycles; any events occurring after initiating the second course were reported in a separate arm instead of this one.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
OG016
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
OG018
Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)
Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
OG019
Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)
One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG0083
OG0093
OG01020
OG011205
OG01240
OG01341
OG01420
OG01520
OG01658
OG01740
OG0189
OG0191
Title
Denominators
Categories
Title
Measurements
OG0003
OG0015
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG0083
OG0093
OG01019
OG011196
OG01240
OG01341
OG01420
OG01520
OG01655
OG01740
OG0187
OG0191
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG004
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG007
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG010
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle. 9 participants with confirmed disease progression per irRECIST 1.1 switched over to Arm 2C and received favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles. Any events occurring after that switch-over are reported in a separate arm instead of this one.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle. One participant received a second course for up to 17 cycles; any events occurring after initiating the second course were reported in a separate arm instead of this one.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
OG016
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
OG018
Part B: Favezelimab Switch Over to Favezelimab 800 mg + Pembrolizumab 200 mg (Switch Over to Arm 2C)
Part B favezelimab monotherapy-treated participants (Arm 1) with confirmed disease progression per irRECIST 1.1 were allowed to switch over to Arm 2C and receive favezelimab 800 mg + pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
OG019
Part B: Second Course Favezelimab 200 mg + Pembrolizumab 200 mg (Second Course Arm 2A)
One participant enrolled in Arm 2A received a second course of favezelimab 200 mg + Pembrolizumab 200 mg on Day 1 of each 21-day cycle for up to 17 cycles.
Units
Counts
Participants
OG0003
OG0016
OG0023
OG0033
OG0043
OG0053
OG0063
OG0073
OG0083
OG0093
OG01020
OG011205
OG01240
OG01341
OG01420
OG01520
OG01658
OG01740
OG0189
OG0191
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0072
OG0081
OG0090
OG0100
OG01122
OG0125
OG0132
OG0146
OG0150
OG0165
OG01711
OG0181
OG0190
Participants with head and neck squamous cell cancer (HNSCC) received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG003
Gastric Cancer Participants in Part B: Favezelimab 200 mg + Pembrolizumab 200 mg (Arm 2A)
Participants with gastric cancer received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Colorectal Cancer Participants in Part B: MK-4280A (Arm 5)
Participants with colorectal cancer received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
OG007
China Enrollment in Part B: MK-4280A (Arm 5)
Participants enrolled in China received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Units
Counts
Participants
OG00020
OG001105
OG00260
OG00340
OG00440
OG00541
OG00639
OG00719
OG00820
OG00920
OG01040
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 16.8)
OG0013.8(1.0 to 9.5)
OG00215.0(7.1 to 26.6)
OG0037.5(1.6 to 20.4)
OG00415.0(5.7 to 29.8)
OG0057.3(1.5 to 19.9)
OG0065.1(0.6 to 17.3)
OG00710.5(1.3 to 33.1)
OG00825.0(8.7 to 49.1)
OG0090.0(0.0 to 16.8)
OG0107.5(1.6 to 20.4)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG003
OG004
Mean Difference (Final Values)
7.5
2-Sided
95
-7.3
22.9
Confidence interval based on Miettinen & Nurminen method
Other
Difference in Percentage
Pooled Favezelimab 70 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Pooled Favezelimab 200 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.
OG004
Pooled Favezelimab 210 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Pooled Favezelimab 700 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
OG006
Pooled Favezelimab 800 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).
OG007
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG010
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG011
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
OG012
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
OG013
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG014
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG015
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG017
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG018
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG024
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG003187
OG0046
OG00545
OG006184
OG0073
OG0086
OG0093
OG0103
OG0113
OG01218
OG0133
OG0142
OG0153
OG016188
OG0173
OG0183
OG01940
OG02040
OG02120
OG02233
OG02320
OG02454
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG0017
ParticipantsOG0026
ParticipantsOG003187
ParticipantsOG0046
ParticipantsOG00545
ParticipantsOG006184
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01218
ParticipantsOG0133
ParticipantsOG0141
ParticipantsOG0153
ParticipantsOG016188
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01940
ParticipantsOG02040
ParticipantsOG02120
ParticipantsOG02233
ParticipantsOG02320
ParticipantsOG02454
Title
Measurements
OG0007.12± 58.8
OG00134.6± 45.4
OG00298.8± 42.7
OG003
Cycle 2
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003123
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0034
Cycle 4
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00344
Cycle 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pooled Favezelimab 70 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Pooled Favezelimab 200 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.
OG004
Pooled Favezelimab 210 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Pooled Favezelimab 700 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
OG006
Pooled Favezelimab 800 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).
OG007
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG010
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG011
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
OG012
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
OG013
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG014
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG015
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG017
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG018
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG024
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0019
OG0026
OG003191
OG0046
OG00546
OG006188
OG0073
OG0086
OG0093
OG0103
OG0113
OG01218
OG0133
OG0143
OG0153
OG016191
OG0173
OG0183
OG01940
OG02040
OG02120
OG02236
OG02320
OG02458
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0026
ParticipantsOG003191
ParticipantsOG0046
ParticipantsOG00546
ParticipantsOG006188
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01218
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0153
ParticipantsOG016191
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01940
ParticipantsOG02040
ParticipantsOG02120
ParticipantsOG02236
ParticipantsOG02320
ParticipantsOG02458
Title
Measurements
OG0007.29± 58.4
OG00137.5± 41.1
OG00296.1± 39.6
OG003
Cycle 2
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG003133
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0036
Cycle 4
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00345
Cycle 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Pooled Favezelimab 70 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG003
Pooled Favezelimab 200 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle.
OG004
Pooled Favezelimab 210 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Pooled Favezelimab 700 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle.
OG006
Pooled Favezelimab 800 mg
This arm is a protocol-specified pooled arm of all participants who received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle, including participants who received it as part of a coformulation with pembrolizumab (MK-4280A).
OG007
Part A: Favezelimab 7 mg Monotherapy
Participants received favezelimab 7 mg intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 21 mg Monotherapy
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG010
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG011
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
OG012
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
OG013
Part A: Favezelimab 7 mg + Pembrolizumab 200 mg
Participants received favezelimab 7 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG014
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG015
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG017
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG018
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG024
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0019
OG0026
OG003203
OG0046
OG00546
OG006195
OG0073
OG0086
OG0093
OG0103
OG0113
OG01218
OG0133
OG0143
OG0153
OG016203
OG0173
OG0183
OG01940
OG02041
OG02120
OG02238
OG02320
OG02458
Title
Denominators
Categories
Cycle 1
ParticipantsOG0006
ParticipantsOG0019
ParticipantsOG0026
ParticipantsOG003203
ParticipantsOG0046
ParticipantsOG00546
ParticipantsOG006195
ParticipantsOG0073
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01218
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0153
ParticipantsOG016203
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01940
ParticipantsOG02041
ParticipantsOG02120
ParticipantsOG02238
ParticipantsOG02320
ParticipantsOG02458
Title
Measurements
OG0002.39± 44.4
OG0018.00± 22
OG00221.9± 34.5
OG003
Cycle 2
ParticipantsOG0005
ParticipantsOG0019
ParticipantsOG0026
ParticipantsOG003163
Cycle 3
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00315
Cycle 4
ParticipantsOG0003
ParticipantsOG0012
ParticipantsOG0023
ParticipantsOG00385
Cycle 8
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG012
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000412
OG0013
OG0022
OG0033
OG004197
OG0053
OG0063
OG00740
OG00840
OG00920
OG01036
OG01120
OG01254
Title
Denominators
Categories
Cycle 1
ParticipantsOG000412
ParticipantsOG0013
ParticipantsOG0021
ParticipantsOG0033
ParticipantsOG004197
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00740
ParticipantsOG00840
ParticipantsOG00920
ParticipantsOG01036
ParticipantsOG01120
ParticipantsOG01254
Title
Measurements
OG000586± 38.9
OG001662± 20.7
OG002332± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG003
Cycle 2
ParticipantsOG000292
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 3
ParticipantsOG0005
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 4
ParticipantsOG000136
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 8
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG012
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000424
OG0013
OG0023
OG0033
OG004197
OG0053
OG0063
OG00740
OG00840
OG00920
OG01038
OG01120
OG01254
Title
Denominators
Categories
Cycle 1
ParticipantsOG000424
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG004197
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00740
ParticipantsOG00840
ParticipantsOG00920
ParticipantsOG01038
ParticipantsOG01120
ParticipantsOG01254
Title
Measurements
OG000427± 31.5
OG001418± 13
OG002485± 49
OG003
Cycle 2
ParticipantsOG000310
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 3
ParticipantsOG00013
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 4
ParticipantsOG000143
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 8
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
OG002
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG003
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG006
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG012
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000435
OG0013
OG0023
OG0033
OG004204
OG0053
OG0063
OG00740
OG00841
OG00920
OG01038
OG01120
OG01257
Title
Denominators
Categories
Cycle 1
ParticipantsOG000435
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
ParticipantsOG004204
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00740
ParticipantsOG00841
ParticipantsOG00920
ParticipantsOG01038
ParticipantsOG01120
ParticipantsOG01257
Title
Measurements
OG00059.6± 29.6
OG00158.5± 14.9
OG00260.0± 22.1
OG003
Cycle 2
ParticipantsOG000338
ParticipantsOG0013
ParticipantsOG0023
ParticipantsOG0033
Cycle 3
ParticipantsOG00019
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Cycle 4
ParticipantsOG000186
ParticipantsOG0013
ParticipantsOG0022
ParticipantsOG0033
Cycle 8
ParticipantsOG0008
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Part A: Favezelimab 21 mg + Pembrolizumab 200 mg
Participants received favezelimab 21 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG004
Part A: Favezelimab 70 mg Monotherapy
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle.
OG005
Part A: Favezelimab 70 mg + Pembrolizumab 200 mg
Participants received favezelimab 70 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 200 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG007
Part A: Favezelimab 210 mg Monotherapy
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle.
OG008
Part A: Favezelimab 210 mg + Pembrolizumab 200 mg
Participants received favezelimab 210 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG009
Part A: Favezelimab 700 mg Monotherapy
Participants received favezelimab 710 mg IV infusion on Day 1 of each 21-day cycle.
OG010
Part A: Favezelimab 700 mg + Pembrolizumab 200 mg
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 700 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
OG012
Part B: Favezelimab 800 mg Monotherapy (Arm 1)
Participants received favezelimab 800 mg monotherapy IV infusion on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS FOLFIRI (irinotecan 180 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV and 5-FU 2400 mg/m^2 IV over 46 to 48 hours, Q2W).
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS oral lenvatinib 20 mg once daily.
Participants received favezelimab 800 mg IV infusion on Day 1 of each 21-day cycle PLUS pembrolizumab 200 mg IV infusion administered sequentially on Day 1 of each 21-day cycle PLUS mFOLFOX7 (oxaliplatin 85 mg/m^2 IV, leucovorin [calcium folinate] 400 mg/m^2 IV, and fluorouracil [5-FU] 2400 mg/m^2 IV over 46 to 48 hours, every 2 weeks [Q2W]).
OG017
Part B: MK-4280A (Arm 5)
Participants received MK-4280A, a coformulation of favezelimab 800 mg + pembrolizumab 200 mg IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0003
OG0013
OG0026
OG0033
OG0043
OG0053
OG006195
OG0073
OG0083
OG0093
OG0103
OG01139
OG01218
OG01341
OG01420
OG01536
OG01620
OG01757
Title
Denominators
Categories
Cycle 1
ParticipantsOG0003
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0053
ParticipantsOG006195
ParticipantsOG0073
ParticipantsOG0083
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG01139
ParticipantsOG01218
ParticipantsOG01341
ParticipantsOG01420
ParticipantsOG01536
ParticipantsOG01620
ParticipantsOG01757
Title
Measurements
OG0000.00(0.00 to 0.00)
OG0010.00(0.00 to 0.00)
OG0020.00(0.00 to 0.00)
OG003
Cycle 2
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0026
ParticipantsOG0033
Cycle 3
ParticipantsOG0001
ParticipantsOG0013
ParticipantsOG0025
ParticipantsOG0033
Cycle 4
ParticipantsOG0000
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0032
Cycle 6
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Cycle 8
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG0031
35
Title
Denominators
Categories
Cycle 1
ParticipantsOG00035
Title
Measurements
OG000NA± NANA= AUC0-inf could not be calculated due to sparse data collection across participants
Cycle 2
ParticipantsOG00024
Title
Measurements
OG000NA± NANA= AUC0-inf could not be calculated due to sparse data collection across participants
35
Title
Denominators
Categories
Cycle 1
ParticipantsOG00035
Title
Measurements
OG000NA± NANA= AUC0-21 Days could not be calculated due to sparse data collection across participants
Cycle 2
ParticipantsOG00024
Title
Measurements
OG000NA± NANA= AUC0-21 Days could not be calculated due to sparse data collection across participants
35
Title
Denominators
Categories
Cycle 1
ParticipantsOG00035
Title
Measurements
OG000NA± NANA= Cmax Days could not be calculated due to sparse data collection across participants
Cycle 2
ParticipantsOG00024
Title
Measurements
OG000NA± NANA= Cmax Days could not be calculated due to sparse data collection across participants
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0131 events1 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0171 events1 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0171 events1 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0151 events1 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0151 events1 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0114 events4 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0114 events4 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0112 events2 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0151 events1 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0171 events1 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0171 events1 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0142 events2 affected58 at risk
EG0150 events0 affected20 at risk
EG0161 events1 affected20 at risk
EG0175 events4 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0081 events1 affected3 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected20 at risk
EG0113 events2 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0172 events2 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0131 events1 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0115 events4 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0151 events1 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0132 events2 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0141 events1 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
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EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0110 events0 affected205 at risk
EG0120 events0 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0160 events0 affected20 at risk
EG0170 events0 affected40 at risk
EG0180 events0 affected9 at risk
EG0191 events1 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected20 at risk
EG0111 events1 affected205 at risk
EG0120 events0 affected40 at risk
EG0132 events2 affected41 at risk
EG0144 events4 affected58 at risk
EG0151 events1 affected20 at risk
EG0160 events0 affected20 at risk
EG01734 events27 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected3 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected3 at risk
EG0092 events1 affected3 at risk
EG0100 events0 affected20 at risk
EG01110 events8 affected205 at risk
EG0121 events1 affected40 at risk
EG0130 events0 affected41 at risk
EG0140 events0 affected58 at risk
EG0150 events0 affected20 at risk
EG0163 events1 affected20 at risk
EG0171 events1 affected40 at risk
EG0180 events0 affected9 at risk
EG0190 events0 affected1 at risk
305
± 48.4
OG004365± 39.8
OG0051480± 39.6
OG0061620± 54.7
OG00710.5± 49
OG00837.4± 43.3
OG00999.3± 28.6
OG010341± 51
OG0111590± 21.5
OG0121820± 46.6
OG0134.81± 25.7
OG01421.5± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG01598.3± 63.7
OG016305± 48.3
OG017391± 36.1
OG0181610± 36.5
OG0191440± 41.6
OG0201430± 46.4
OG0211670± 40.3
OG0221870± 75.1
OG0232010± 54.5
OG0241430± 49.6
Participants
OG004
6
ParticipantsOG00536
ParticipantsOG006113
ParticipantsOG0071
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01210
ParticipantsOG0133
ParticipantsOG0140
ParticipantsOG0153
ParticipantsOG016127
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01930
ParticipantsOG02025
ParticipantsOG02117
ParticipantsOG0220
ParticipantsOG02319
ParticipantsOG02444
Title
Measurements
OG0008.28± 45.8
OG00133.1± 41.3
OG00256.0± 179.4
OG003330± 58.1
OG004335± 48.5
OG0051730± 53.1
OG0061850± 59.2
OG00714.6± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG00833.1± 41.3
OG00960.0± 92.4
OG010298± 51.6
OG0111640± 20.5
OG0122200± 42.8
OG0136.86± 27.3
OG01552.2± 429.4
OG016324± 58.7
OG017378± 53.1
OG0182330± 18.4
OG0191690± 57.4
OG0201450± 49.9
OG0212300± 46.6
OG0232690± 55
OG0241580± 61.9
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0064
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0124
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0164
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0191
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0240
Title
Measurements
OG003248± 33.6
OG0052000± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0063880± 16.9
OG0123880± 16.8
OG016248± 33.6
OG0192000± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
Participants
OG004
3
ParticipantsOG00513
ParticipantsOG00637
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG01645
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG01912
ParticipantsOG0206
ParticipantsOG0215
ParticipantsOG0220
ParticipantsOG0233
ParticipantsOG02419
Title
Measurements
OG0009.38± 22.3
OG00113.7± 79.5
OG00288.2± 80.4
OG003329± 71.5
OG004166± 114.5
OG0051870± 56.5
OG0061860± 58.6
OG00946.1± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG010113± 109.9
OG0122880± 55.2
OG0139.38± 22.3
OG01413.7± 79.5
OG015122± 66.4
OG016330± 70.6
OG017357± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0181240± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0191940± 57.5
OG0201570± 40.7
OG0212370± 44.6
OG0232070± 73.8
OG0241640± 62.4
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0246
Title
Measurements
OG0062030± 67.6
OG0242030± 67.6
285
± 42.8
OG004353± 38.4
OG0051300± 34.1
OG0061430± 48.1
OG00711.0± 38.6
OG00836.5± 42.4
OG00997.2± 28.5
OG010333± 49.6
OG0111440± 23.2
OG0121550± 35.8
OG0134.82± 28.5
OG01439.6± 47.7
OG01595.0± 57.5
OG016285± 42.8
OG017374± 34.9
OG0181370± 30.0
OG0191290± 35.5
OG0201330± 40.5
OG0211420± 34.8
OG0221640± 71.9
OG0231630± 41.6
OG0241290± 43.7
Participants
OG004
6
ParticipantsOG00536
ParticipantsOG006120
ParticipantsOG0072
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01212
ParticipantsOG0133
ParticipantsOG0140
ParticipantsOG0153
ParticipantsOG016133
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01930
ParticipantsOG02027
ParticipantsOG02117
ParticipantsOG0220
ParticipantsOG02320
ParticipantsOG02444
Title
Measurements
OG0007.83± 73.1
OG00132.7± 40.1
OG00256.4± 154.4
OG003300± 51.4
OG004321± 44.9
OG0051480± 43
OG0061570± 54.9
OG0079.32± 184.6
OG00832.7± 40.1
OG00959.3± 88.6
OG010292± 48.3
OG0111470± 15.7
OG0122140± 40.9
OG0136.97± 25.7
OG01553.7± 327.1
OG016300± 51.4
OG017353± 49.8
OG0181640± 38.7
OG0191460± 46
OG0201260± 65.1
OG0211820± 37.2
OG0232050± 43.6
OG0241400± 51.9
Participants
OG004
0
ParticipantsOG0051
ParticipantsOG0065
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0125
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0166
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0191
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0240
Title
Measurements
OG003241± 26.4
OG0051770± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0062330± 51.5
OG0122330± 51.5
OG016241± 26.4
OG0191770± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
Participants
OG004
3
ParticipantsOG00513
ParticipantsOG00637
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0124
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG01645
ParticipantsOG0171
ParticipantsOG0181
ParticipantsOG01912
ParticipantsOG0206
ParticipantsOG0215
ParticipantsOG0220
ParticipantsOG0234
ParticipantsOG02419
Title
Measurements
OG0009.57± 21.9
OG00113.8± 81
OG00289.6± 65
OG003306± 63.4
OG004174± 91
OG0051620± 44.2
OG0061710± 53.6
OG00953.1± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG010124± 83.4
OG0122320± 34.6
OG0139.57± 21.9
OG01413.8± 81
OG015116± 58.6
OG016306± 63.4
OG017341± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0181120± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG0191670± 44.6
OG0201500± 37.7
OG0212070± 40.4
OG0232330± 90.1
OG0241490± 53.7
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0066
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0246
Title
Measurements
OG0061730± 51.8
OG0241730± 51.8
56.7
± 32.2
OG00477.4± 29.9
OG005224± 27
OG006248± 27.8
OG0073.16± 44.9
OG0088.62± 17.6
OG00923.7± 21.9
OG01074.9± 28.8
OG011216± 19.9
OG012271± 20.7
OG0131.80± 17.9
OG0146.88± 25.2
OG01520.2± 48.9
OG01656.7± 32.2
OG01780.0± 37.5
OG018252± 46.6
OG019223± 26.5
OG020248± 20.5
OG021219± 23.6
OG022281± 35.7
OG023244± 33.9
OG024234± 24.5
Participants
OG004
6
ParticipantsOG00540
ParticipantsOG006138
ParticipantsOG0072
ParticipantsOG0086
ParticipantsOG0093
ParticipantsOG0103
ParticipantsOG0113
ParticipantsOG01215
ParticipantsOG0133
ParticipantsOG0143
ParticipantsOG0153
ParticipantsOG016163
ParticipantsOG0173
ParticipantsOG0183
ParticipantsOG01934
ParticipantsOG02035
ParticipantsOG02118
ParticipantsOG0220
ParticipantsOG02320
ParticipantsOG02450
Title
Measurements
OG0002.44± 46.5
OG0018.62± 29.2
OG00219.3± 47.1
OG00356.8± 34.9
OG00476.7± 21.1
OG005247± 32
OG006247± 36.6
OG0072.67± 97.4
OG0089.65± 19.6
OG00920.8± 21.8
OG01070.6± 23.3
OG011222± 15.8
OG012301± 18
OG0132.30± 21.4
OG0146.88± 35.3
OG01517.9± 74
OG01656.8± 34.9
OG01783.3± 19.2
OG018238± 58.9
OG019250± 31.5
OG020228± 53.8
OG021245± 25.5
OG023266± 35.4
OG024240± 28.6
Participants
OG004
0
ParticipantsOG0053
ParticipantsOG00610
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG01210
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG01615
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0193
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0240
Title
Measurements
OG00319.2± 138.4
OG005150± 54
OG006272± 45.6
OG012272± 45.6
OG01619.2± 138.4
OG019150± 54
Participants
OG004
3
ParticipantsOG00521
ParticipantsOG00679
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0091
ParticipantsOG0102
ParticipantsOG0110
ParticipantsOG0129
ParticipantsOG0133
ParticipantsOG0142
ParticipantsOG0152
ParticipantsOG01685
ParticipantsOG0171
ParticipantsOG0182
ParticipantsOG01919
ParticipantsOG02019
ParticipantsOG02112
ParticipantsOG0220
ParticipantsOG02315
ParticipantsOG02424
Title
Measurements
OG0003.02± 6.2
OG0016.11± 39.4
OG00227.0± 30.6
OG00358.6± 34.6
OG00454.0± 9.3
OG005253± 35
OG006265± 32.2
OG00924.5± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG01055.3± 11.8
OG012332± 19.4
OG0133.02± 6.3
OG0146.11± 39.4
OG01528.3± 42.5
OG01658.6± 34.6
OG01751.4± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG018145± 37.5
OG019269± 29.4
OG020252± 26.1
OG021267± 35.7
OG023262± 34.5
OG024254± 35.9
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0068
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
ParticipantsOG0130
ParticipantsOG0140
ParticipantsOG0150
ParticipantsOG0160
ParticipantsOG0170
ParticipantsOG0180
ParticipantsOG0190
ParticipantsOG0200
ParticipantsOG0210
ParticipantsOG0220
ParticipantsOG0230
ParticipantsOG0248
Title
Measurements
OG006292± 26.6
OG024292± 26.6
612
± 40.8
OG004564± 40.8
OG005821± 18.2
OG006543± 27.4
OG007586± 39.1
OG008589± 34.4
OG009626± 26.7
OG010623± 44.6
OG011661± 32.9
OG012619± 41.3
Participants
OG004
150
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00732
ParticipantsOG00830
ParticipantsOG00918
ParticipantsOG0100
ParticipantsOG01119
ParticipantsOG01245
Title
Measurements
OG000843± 52.1
OG0011060± 22.4
OG002613± 100.5
OG003940± 46.3
OG004807± 50.6
OG005727± 67.2
OG006847± 23.2
OG007877± 53.7
OG008812± 41.4
OG0091150± 59.8
OG0111100± 48.8
OG012861± 75.4
Participants
OG004
7
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0071
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000846± 98
OG004878± 72.1
OG0071990± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
Participants
OG004
71
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG00716
ParticipantsOG00810
ParticipantsOG0097
ParticipantsOG0100
ParticipantsOG01110
ParticipantsOG01217
Title
Measurements
OG000903± 49.2
OG0011190± 17
OG002503± 101.3
OG0033650± 181.2
OG004894± 47.9
OG005962± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG006528± 43.0
OG007997± 56.6
OG008848± 37.8
OG0091000± 21.6
OG011929± 35.7
OG0121040± 73
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0126
Title
Measurements
OG0001980± 54.8
OG0121970± 55
382
± 36.7
OG004412± 31.1
OG005556± 15.2
OG006410± 30.0
OG007422± 28.5
OG008427± 25.2
OG009431± 24
OG010489± 39.3
OG011447± 32.8
OG012427± 34.2
Participants
OG004
150
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00732
ParticipantsOG00831
ParticipantsOG00918
ParticipantsOG0100
ParticipantsOG01120
ParticipantsOG01245
Title
Measurements
OG000561± 38
OG001615± 16.8
OG002504± 88.8
OG003597± 38.3
OG004545± 36.6
OG005662± 57.6
OG006487± 27.9
OG007588± 35.4
OG008553± 25.1
OG009618± 22.9
OG011621± 32.4
OG012547± 56.9
Participants
OG004
11
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0072
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG000543± 38.7
OG004537± 40.1
OG007577± 43.9
Participants
OG004
71
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG00716
ParticipantsOG00810
ParticipantsOG0097
ParticipantsOG0100
ParticipantsOG01110
ParticipantsOG01217
Title
Measurements
OG000692± 39.3
OG001805± 5
OG002403± 74.6
OG0031050± 79.9
OG004670± 36.4
OG005701± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant
OG006416± 15.7
OG007754± 45.4
OG008664± 31.9
OG009769± 21.3
OG011727± 36.7
OG012705± 45.7
Participants
OG004
0
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0126
Title
Measurements
OG0001040± 37.5
OG0121040± 37.5
52.8
± 51.5
OG00458.7± 32.3
OG00574.2± 39.1
OG00657.4± 32.8
OG00763.9± 26.2
OG00861.3± 19.2
OG00955.5± 20.5
OG01065.0± 34
OG01159.6± 30.9
OG01256.6± 25.6
Participants
OG004
165
ParticipantsOG0053
ParticipantsOG0063
ParticipantsOG00734
ParticipantsOG00835
ParticipantsOG00918
ParticipantsOG0100
ParticipantsOG01120
ParticipantsOG01251
Title
Measurements
OG00067.5± 34.3
OG00165.6± 21.2
OG00278.7± 48.1
OG00369.9± 37.1
OG00466.7± 29.7
OG00591.9± 14.1
OG00667.6± 9.36
OG00777.4± 33.7
OG00867.0± 22.2
OG00969.0± 22.6
OG01169.9± 32.9
OG01261.1± 55.1
Participants
OG004
16
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0073
ParticipantsOG0080
ParticipantsOG0090
ParticipantsOG0100
ParticipantsOG0110
ParticipantsOG0120
Title
Measurements
OG00036.4± 41.9
OG00436.7± 44.2
OG00735.1± 35.3
Participants
OG004
86
ParticipantsOG0051
ParticipantsOG0062
ParticipantsOG00719
ParticipantsOG00819
ParticipantsOG00912
ParticipantsOG0100
ParticipantsOG01115
ParticipantsOG01224
Title
Measurements
OG00076.1± 30.2
OG00179.6± 7.8
OG00259.3± 50.1
OG00383.7± 83
OG00475.3± 26.6
OG00561.2± NANA= The Geometric Coefficient of Variation cannot be calculated for a single participant