Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
Official Title
Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Apr 2026
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
Dec 30, 2020Actual
Primary Completion Date
Oct 29, 2024Actual
Completion Date
Mar 30, 2026Actual
First Submitted Date
Dec 4, 2020
First Submission Date that Met QC Criteria
Dec 4, 2020
First Posted Date
Dec 10, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Oct 6, 2025
Results First Submitted that Met QC Criteria
Nov 26, 2025
Results First Posted Date
Nov 28, 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
Apr 9, 2026
Last Update Posted Date
Apr 28, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Name
Class
Eisai Inc.
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.
The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.
Detailed Description
There will be 2 parts to the study: a Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (Safety Run-in), approximately 12 participants will be treated with lenvatinib in combination with pembrolizumab and chemotherapy with either capecitabine and oxaliplatin (CAPOX), or 5-fluorouracil (5-FU), Leucovorin, and oxaliplatin (mFOLFOX6). Participants will be closely followed for dose-limiting toxicities for 21 days after the first dose of study intervention.
In Part 2, up to 878 eligible participants (not including those participating in Part 1) will be randomly assigned in a 1:1 ratio to either lenvatinib plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) or Chemotherapy alone (CAPOX or mFOLFOX6).
Participants can receive up to 18 infusions (up to 2 years) of pembrolizumab in the first course. Participants may be eligible to receive a second course of pembrolizumab (approximately 1 year) at the investigator's discretion.
As of Amendment 8 (Effective 06/10/2025), Second Course will no longer be offered. Any participant currently receiving Second Course retreatment will be able to continue treatment as planned. Imaging will be performed per local standard of care.
Participants receive lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab (400 mg Q6W) plus chemotherapy (CAPOX or mFOLFOX6) will be administered for 2 cycles (approximately 12 weeks), followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab (400 mg Q6W) for 16 cycles. A cycle is 6 weeks (42 days).
Biological: Pembrolizumab
Biological: Lenvatinib
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Leucovorin (or Levoleucovorin)
Drug: 5-FU
Chemotherapy
Experimental
Participants receive chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Leucovorin (or Levoleucovorin)
Drug: 5-FU
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
400 mg Q6W by IV infusion
Lenvatinib + Pembrolizumab + Chemotherapy
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs included Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Nonhematologic DLTs included any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥ Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event, or any Grade 3 nonhematologic laboratory value if medical intervention was required or the abnormality led to hospitalization. The number of participants in Part 1 with DLTs is reported.
Up to ~21 days
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 with AEs is reported
Up to ~44 months
Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 that discontinued study treatment due to an AE is reported.
Up to ~29 months
Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Secondary Outcomes
Measure
Description
Time Frame
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
ORR is defined as the percentage of participants in the analysis population who have 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) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
Is not expected to require tumor resection during the treatment course
Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER-2)/neu positive
Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by scan with IV contrast as determined by the local site investigator
Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment
Has adequately controlled blood pressure with or without antihypertensive medications
Has adequate organ function
Exclusion Criteria:
Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
Has had major surgery within 28 days prior to first dose of study interventions
Has had radiotherapy within 14 days of randomization
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
Has had an allogeneic tissue/solid organ transplant
Has perforation risks or significant gastrointestinal (GI) bleeding
Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
Has received prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
Has inadequate cardiac function
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has poorly controlled diarrhea
Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
Has peripheral neuropathy ≥Grade 2
Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection
Has weight loss of >20% within the last 3 months
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
Facility
Status
City
State
ZIP
Country
Contacts
UCLA Hematology/Oncology - Santa Monica ( Site 0003)
Shitara K, Lorenzen S, Li J, Bai Y, Fernandez MG, Aguilar M, Shoji H, Reyes-Cosmelli F, Pena YR, Corrales L, Wyrwicz L, Eyzaguirre DA, Pan Y, Ryu MH, Cohen DJ, Wainberg ZA, Ku G, Tabernero J, Van Cutsem E, Qin SK, Oh DY, Xu J, Liang LW, Bordia S, Bhagia P, Rha SY; LEAP-015 Investigators. Lenvatinib Plus Pembrolizumab and Chemotherapy Versus Chemotherapy in Advanced Metastatic Gastroesophageal Adenocarcinoma: The Phase III, Randomized LEAP-015 Study. J Clin Oncol. 2025 Aug;43(22):2502-2514. doi: 10.1200/JCO-25-00748. Epub 2025 May 31.
This study included 2 parts: Part 1 was an open-label, safety run-in to evaluate the safety and tolerability of treatment with pembrolizumab + lenvatinib + chemotherapy. Participants in Part 1 continued to receive study intervention and were followed in the posttreatment period as applicable. Part 2 (main study) evaluated safety and efficacy. Participants were randomized to receive either treatment with pembrolizumab + lenvatinib + chemotherapy, or chemotherapy only.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
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
Jun 10, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
MK-3475
Keytruda®
Lenvatinib
Biological
Administered PO QD, 8 mg induction/20 mg consolidation.
Lenvatinib + Pembrolizumab + Chemotherapy
MK-7902
E7080
Oxaliplatin
Drug
130 mg/m^2 administered by IV infusion on Day 1 of Weeks 1 and 4 of each Q6W cycle as part of CAPOX chemotherapy, or 85 mg/m^2 administered by IV infusion on Day 1 and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
Chemotherapy
Lenvatinib + Pembrolizumab + Chemotherapy
Capecitabine
Drug
1000 mg/m^2 administered PO twice daily (BID) on Days 1-14, 22-35 of each Q6W cycle as part of CAPOX chemotherapy.
Chemotherapy
Lenvatinib + Pembrolizumab + Chemotherapy
Leucovorin (or Levoleucovorin)
Drug
Administered by IV infusion at 400 mg/m^2 (leucovorin) or 200 mg/m^2 (levoleucovorin) on Day 1, and Week 1, 3 and 5 of each Q6W cycle as part of mFOLFOX6 chemotherapy.
Chemotherapy
Lenvatinib + Pembrolizumab + Chemotherapy
5-FU
Drug
400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous IV infusion administered on Day 1, and Week 1, 3, 5, of each Q2W cycle as part of mFOLFOX6 chemotherapy.
Chemotherapy
Lenvatinib + Pembrolizumab + Chemotherapy
Up to ~41 months
Part 2: OS in All Participants
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for all participants in Part 2.
Up to ~41 months
Part 2: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Up to ~29 months
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for all participants in Part 2.
Up to ~29 months
Up to ~29 months
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
ORR is defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for all participants in Part 2.
Up to ~29 months
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
Up to ~41 months
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR is reported by treatment arm for all participants in Part 2.
Up to ~41 months
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with AEs is reported by treatment arm.
Up to ~41 months
Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 that discontinued study treatment due to an AE is reported by treatment arm.
Up to ~41 months
Georgetown University Medical Center ( Site 0009)
Washington D.C.
District of Columbia
20007
United States
James Graham Brown Cancer Center ( Site 0017)
Louisville
Kentucky
40202
United States
Johns Hopkins University ( Site 0052)
Baltimore
Maryland
21224
United States
Dana Farber Cancer Center ( Site 0019)
Boston
Massachusetts
02215
United States
UMASS Memorial Medical Center ( Site 0020)
Worcester
Massachusetts
01655
United States
Henry Ford Health System ( Site 0023)
Detroit
Michigan
48202
United States
Cancer and Hematology Centers of Western Michigan ( Site 0025)
Grand Rapids
Michigan
49503
United States
Washington University School of Medicine ( Site 0027)
St Louis
Missouri
63110
United States
Mount Sinai Hospital ( Site 0051)
New York
New York
10029
United States
Memorial Sloan Kettering Cancer Center ( Site 0032)
New York
New York
10065
United States
AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
Pittsburgh
Pennsylvania
15224
United States
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
Caba
Buenos Aires
C1012AAR
Argentina
Instituto Medico Alexander Fleming ( Site 0208)
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1426ANZ
Argentina
Fundacion Favaloro ( Site 0201)
Buenos Aires
C1093AAS
Argentina
Hospital Aleman ( Site 0210)
Buenos Aires
C1118AAT
Argentina
Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
Buenos Aires
C1264AAA
Argentina
CEMIC ( Site 0209)
Buenos Aires
C1431FWO
Argentina
Hospital Privado de Cordoba ( Site 0204)
Córdoba
X5016KEH
Argentina
Nepean Hospital ( Site 2305)
Kingswood
New South Wales
2747
Australia
Wollongong Hospital ( Site 2307)
Wollongong
New South Wales
2500
Australia
Royal Brisbane and Women s Hospital ( Site 2304)
Herston
Queensland
4029
Australia
Hollywood Private Hospital-Medical Oncology ( Site 2308)
Nedlands
Western Australia
6009
Australia
CHU UCL Namur Site de Godinne ( Site 1005)
Yvoir
Namur
5530
Belgium
UZ Gent ( Site 1002)
Ghent
Oost-Vlaanderen
9000
Belgium
UZ Leuven ( Site 1004)
Leuven
Vlaams-Brabant
3000
Belgium
AZ Delta ( Site 1006)
Roeselare
West-Vlaanderen
8800
Belgium
Queen Elizabeth II Health Sciences Centre ( Site 0101)
Halifax
Nova Scotia
B3H 2Y9
Canada
Hamilton Health Sciences - Juravinski Site ( Site 0106)
Hamilton
Ontario
L8V 5C2
Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
Sherbrooke
Quebec
J1H 5N4
Canada
Centro Investigación del Cáncer James Lind ( Site 0414)
Temuco
Araucania
Temuco
Chile
IC La Serena Research ( Site 0410)
La Serena
Coquimbo Region
1720430
Chile
Clinica Universidad Catolica del Maule ( Site 0411)
Talca
Maule Region
3460000
Chile
Fundacion Arturo Lopez Perez FALP ( Site 0403)
Santiago
Region M. de Santiago
7500836
Chile
Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
Santiago
Region M. de Santiago
7550000
Chile
Bradfordhill ( Site 0404)
Santiago
Region M. de Santiago
8420383
Chile
Anhui Provincial Hospital ( Site 2415)
Hefei
Anhui
230001
China
Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
Beijing
Beijing Municipality
100021
China
Beijing Cancer Hospital ( Site 2453)
Beijing
Beijing Municipality
100035
China
Fujian Provincial Cancer Hospital ( Site 2408)
Fuzhou
Fujian
350014
China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
Fuzhou
Fujian
350025
China
The First Affiliated Hospital of Xiamen University ( Site 2420)
Xiamen
Fujian
361003
China
The First Affiliated Hospital of Xiamen University ( Site 2446)
Xiamen
Fujian
361003
China
Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
Xiamen
Fujian
361004
China
First Hospital of Lanzhou University ( Site 2417)
Lanzhou
Gansu
730000
China
Nanfang Hospital ( Site 2456)
Guangzhou
Guangdong
510000
China
The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
Haikou
Hainan
570102
China
Fourth Hospital Of Hebei Medical University ( Site 2441)
Shijiazhuang
Hebei
050011
China
Harbin Medical University Cancer Hospital ( Site 2410)
Harbin
Heilongjiang
150081
China
Henan Cancer Hospital ( Site 2443)
Zhengzhou
Henan
450008
China
Hubei Cancer Hospital ( Site 2429)
Wuhan
Hubei
430079
China
Hunan Cancer Hospital ( Site 2440)
Changsha
Hunan
410006
China
Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
Changzhou
Jiangsu
213000
China
Nanjing Drum Tower Hospital ( Site 2419)
Nanjing
Jiangsu
210008
China
Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
Nantong
Jiangsu
226361
China
Jilin Cancer Hospital ( Site 2438)
Changchun
Jilin
130012
China
Tang Du Hospital ( Site 2432)
Xi'an
Shaanxi
710038
China
LinYi Cancer Hospital-Gastrology department ( Site 2463)
Linyi
Shandong
276000
China
Shanghai General Hospital ( Site 2424)
Shanghai
Shanghai Municipality
200080
China
Shanghai East Hospital ( Site 2455)
Shanghai
Shanghai Municipality
200120
China
Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
Tianjin
Tianjin Municipality
300060
China
Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
Ürümqi
Xinjiang
830011
China
The First Affiliated Hospital of Zhejiang University ( Site 2414)
Hangzhou
Zhejiang
310009
China
Sir Run Run Shaw Hospital ( Site 2412)
Hangzhou
Zhejiang
310016
China
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla
Atlántico
080020
Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
Bogotá
Bogota D.C.
111321
Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
Valledupar
Cesar Department
200001
Colombia
Oncomedica S.A. ( Site 0507)
Montería
Departamento de Córdoba
230002
Colombia
Instituto Cancerologico de Narino Ltda ( Site 0504)
Pasto
Departamento de Nariño
520001
Colombia
Oncologos del Occidente S.A. ( Site 0525)
Pereira
Risaralda Department
660001
Colombia
CIMCA-Hemato-Oncology ( Site 0601)
San José
Provincia de San José
10103
Costa Rica
Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
Santa Ana
Provincia de San José
10903
Costa Rica
Hôpital Edouard Herriot ( Site 1116)
Lyon
Auvergne-Rhône-Alpes
69003
France
Centre Francois Baclesse ( Site 1107)
Caen
Calvados
14076
France
Centre Georges Francois Leclerc ( Site 1106)
Dijon
Cote-d Or
21079
France
CHU Bordeaux Haut-Leveque ( Site 1110)
Pessac
Gironde
33604
France
Centre Hospitalier Annecy Genevois ( Site 1117)
Epagny Metz-Tessy
Haute-Savoie
74370
France
CHU Hotel Dieu Nantes ( Site 1101)
Nantes
Pays de la Loire Region
44093
France
Hopital Henri Mondor ( Site 1105)
Créteil
Val-de-Marne
94010
France
Institut du Cancer Avignon-Provence ( Site 1103)
Avignon
Vaucluse
84918
France
Hopital Saint Louis ( Site 1100)
Paris
75010
France
CHU Hopital Saint Antoine ( Site 1102)
Paris
75012
France
Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
Muechen
Bavaria
81675
Germany
Universitaetsklinikum Regensburg ( Site 1203)
Regensburg
Bavaria
93053
Germany
Krankenhaus Nordwest ( Site 1205)
Frankfurt am Main
Hesse
60488
Germany
Medizinische Hochschule Hannover ( Site 1210)
Hanover
Lower Saxony
30625
Germany
Universitaetsklinikum Leipzig ( Site 1211)
Leipzig
Saxony
04103
Germany
Charite Berlin Campus Virchow-Klinikum ( Site 1202)
Berlin
13353
Germany
Facharztzentrum Eppendorf ( Site 1201)
Hamburg
20249
Germany
Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
Guatemala City
01010
Guatemala
Oncologika S.A. ( Site 0704)
Guatemala City
01010
Guatemala
Oncomedica ( Site 0701)
Guatemala City
01010
Guatemala
Soluciones Gastrointestinales S.A. ( Site 0706)
Guatemala City
01010
Guatemala
Sanatorio Nuestra Senora del Pilar ( Site 0705)
Guatemala City
01015
Guatemala
Medi-K Cayala ( Site 0700)
Guatemala City
01016
Guatemala
Prince of Wales Hospital ( Site 2503)
Hong Kong
Hong Kong
Princess Margaret Hospital. ( Site 2502)
Hong Kong
Hong Kong
Queen Mary Hospital ( Site 2501)
Hong Kong
Hong Kong
St James Hospital ( Site 1400)
Dublin
Leinster
Dublin 8
Ireland
Beaumont Hospital ( Site 1402)
Dublin
Dublin 9
Ireland
Soroka Medical Center ( Site 1507)
Beersheba
8410101
Israel
Hillel Yaffe Medical Center ( Site 1503)
Hadera
3810004
Israel
Rambam Health Care Campus-Oncology Division ( Site 1502)
Haifa
3109601
Israel
Hadassah Ein Kerem Medical Center ( Site 1501)
Jerusalem
9112001
Israel
Meir Medical Center ( Site 1504)
Kfar Saba
4428164
Israel
Rabin Medical Center ( Site 1506)
Petah Tikva
4941492
Israel
Sourasky Medical Center ( Site 1500)
Tel Aviv
6423906
Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
Meldola
Abruzzo
47014
Italy
Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
Udine
Friuli Venezia Giulia
33100
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
Milan
Lombardy
20133
Italy
Humanitas Research Hospital ( Site 1600)
Rozzano
Lombardy
20089
Italy
AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
Vicenza
Veneto
36100
Italy
Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
Catanzaro
88100
Italy
IRCCS Ospedale San Raffaele di Milano ( Site 1603)
Milan
20132
Italy
A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
Naples
80131
Italy
Aichi Cancer Center Hospital ( Site 2603)
Nagoya
Aichi-ken
464-8681
Japan
National Cancer Center Hospital East ( Site 2601)
Kashiwa
Chiba
277-8577
Japan
National Hospital Organization Shikoku Cancer Center ( Site 2610)
Matsuyama
Ehime
791-0280
Japan
Hyogo Cancer Center ( Site 2621)
Akashi
Hyōgo
673-8558
Japan
Kobe City Medical Center General Hospital ( Site 2606)
Kobe
Hyōgo
650-0047
Japan
Ibaraki Prefectural Central Hospital ( Site 2618)
Kasama
Ibaraki
309-1793
Japan
Kagawa University Hospital ( Site 2611)
Kita-gun
Kagawa-ken
761-0793
Japan
Kanagawa Cancer Center ( Site 2608)
Yokohama
Kanagawa
241-8515
Japan
Kansai Medical University Hospital ( Site 2622)
Hirakata
Osaka
573-1191
Japan
Kindai University Hospital ( Site 2600)
Sayama
Osaka
5898511
Japan
Saitama Cancer Center ( Site 2604)
Kitaadachi-gun
Saitama
362-0806
Japan
National Hospital Organization Kyushu Cancer Center ( Site 2609)
Fukuoka
811-1395
Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
Hiroshima
730-8518
Japan
Osaka International Cancer Institute ( Site 2607)
Osaka
5418567
Japan
National Cancer Center Hospital ( Site 2602)
Tokyo
104-0045
Japan
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo
135-8550
Japan
Przychodnia Lekarska KOMED ( Site 1701)
Konin
Greater Poland Voivodeship
62-500
Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
Poznan
Greater Poland Voivodeship
60-780
Poland
Dolnoslaskie Centrum Onkologii. ( Site 1712)
Wroclaw
Lower Silesian Voivodeship
53-413
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
Warsaw
Masovian Voivodeship
02-034
Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
Przemyśl
Podkarpackie Voivodeship
37-700
Poland
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
Chelyabinsk
Chelyabinsk Oblast
454087
Russia
National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
Moscow
Moscow
105203
Russia
Blokhin National Medical Oncology ( Site 1800)
Moscow
Moscow
115478
Russia
Central Clinical Hospital with Polyclinic ( Site 1801)
Moscow
Moscow
121359
Russia
Medical University REAVIZ ( Site 1814)
Samara
Samara Oblast
443011
Russia
Leningrad Regional Oncology Center ( Site 1810)
Saint Petersburg
Sankt-Peterburg
188663
Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
Saint Petersburg
Sankt-Peterburg
197758
Russia
St Petersburg City Clinical Oncology Dispensary ( Site 1808)
Saint Petersburg
Sankt-Peterburg
198255
Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
Yaroslavl
Yaroslavl Oblast
150054
Russia
Hallym University Sacred Heart Hospital ( Site 2806)
Anyang-si
Kyonggi-do
14068
South Korea
Seoul National University Bundang Hospital ( Site 2804)
Seongnam-si
Kyonggi-do
13620
South Korea
Asan Medical Center ( Site 2802)
Songpagu
Seoul
05505
South Korea
Konyang University ( Site 2807)
Daejeon
Taejon-Kwangyokshi
35365
South Korea
Seoul National University Hospital ( Site 2803)
Seoul
03080
South Korea
Severance Hospital Yonsei University Health System ( Site 2800)
Seoul
03722
South Korea
Gangnam Severance Hospital ( Site 2805)
Seoul
06273
South Korea
Samsung Medical Center ( Site 2801)
Seoul
06351
South Korea
Korea University Guro Hospital ( Site 2808)
Seoul
08308
South Korea
Hospital Universitario Marques de Valdecilla ( Site 1902)
Santander
Cantabria
39008
Spain
Hospital Universitario General de Asturias ( Site 1901)
Oviedo
Principality of Asturias
33011
Spain
Hospital General Universitari Vall d Hebron ( Site 1907)
Barcelona
08035
Spain
Hospital General Gregorio Maranon de Madrid ( Site 1904)
Madrid
28007
Spain
China Medical University Hospital ( Site 2903)
Taichung
40447
Taiwan
National Cheng Kung University Hospital ( Site 2904)
Tainan
704
Taiwan
National Taiwan University Hospital ( Site 2901)
Taipei
10048
Taiwan
Chang Gung Medical Foundation. Linkou ( Site 2902)
Taoyuan
333
Taiwan
Sakarya Universitesi Tip Fakultesi ( Site 2007)
Sakarya
Istanbul
54290
Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
Ankara
06100
Turkey (Türkiye)
Memorial Ankara Hastanesi ( Site 2004)
Ankara
06520
Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2000)
Edirne
22030
Turkey (Türkiye)
Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
Erzurum
25240
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
Istanbul
34098
Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
Izmir
35040
Turkey (Türkiye)
Addenbrooke's Hospital ( Site 2200)
Cambridge
Cambridgeshire
CB2 0QQ
United Kingdom
Ninewells Hospital and Medical School ( Site 2207)
Dundee
Dundee City
DD1 9SY
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 2204)
Glasgow
Glasgow City
G12 0YN
United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 2201)
London
London, City of
NW1 2BU
United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2202)
London
London, City of
SW3 6JJ
United Kingdom
Royal Marsden NHS Trust ( Site 2203)
Sutton
Surrey
SM2 5PT
United Kingdom
University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
Participants received lenvatinib administered orally (PO) every day (QD) in combination with pembrolizumab intravenously (IV) every 6 weeks (Q6W) plus chemotherapy with either capecitabine and oxaliplatin (CAPOX) or chemotherapy with 5-FU, leucovorin, and oxaliplatin (mFOLFOX6). Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
FG002
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX every 3 weeks (Q3W) or mFOLFOX6 every 2 weeks (Q2W).
FG00015 subjects
FG001443 subjects
FG002437 subjects
Treated
FG00015 subjects
FG001441 subjects
FG002429 subjects
Received Second Course of Pembrolizumab +/- Lenvatinib
FG0001 subjects
FG0013 subjects
FG0020 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00015 subjects
FG001443 subjects
FG002437 subjects
Type
Comment
Reasons
Death
FG00014 subjects
FG001331 subjects
FG002367 subjects
Ongoing
FG0001 subjects
FG001109 subjects
FG00256 subjects
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG00214 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Lenvatinib +Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
BG001
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
BG002
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00015
BG001443
BG002437
BG003895
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
BG00055.9± 59.7
BG00159.7± 12.5
BG00259.1± 12.0
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG001151
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG001116
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG00111
BG002
Geographic Region of Enrolling Site
Participants were classified according to the geographic region of enrolling site in the following categories: East Asia, North America + Western Europe (included United States, Canada, Belgium, France, Germany, Ireland, Italy, Spain, United Kingdom, Israel and Australia) and Rest of World.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
East Asia
BG0004
BG001
Eastern Cooperative Oncology Group (ECOG) Performance Status
Participants were assessed for ECOG performance status: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
ECOG 0
BG00011
BG001
Intended Chemotherapy
Participants were classified according to the type of chemotherapy they were intended to receive: CAPOX [capecitabine 1000 mg/m2 BID for 14 days (oral) and oxaliplatin 130 mg/m2 (IV) q3w] or mFOLFOX6 [oxaliplatin 85 mg/m2 (IV), 5-FU 400 mg/m2 (bolus IV)plus 2400 mg/m2 (continuous IV), and leucovorin 400mg/m2 (IV) or levoleucovorin 200 mg/m2 (IV) q2w]
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
CAPOX
BG0007
BG001
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
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
A DLT was defined as a specific adverse event graded for toxicity using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Hematologic DLTs included Grade 4 neutropenia lasting for ≥7 days, Grade 3 or Grade 4 febrile neutropenia, Grade 3 thrombocytopenia with bleeding, Grade 4 thrombocytopenia, or Grade 4 anemia. Nonhematologic DLTs included any other Grade 4 or Grade 5 toxicity, Grade 3 toxicities lasting >3 days (excluding nausea, vomiting, and diarrhea controlled by medical intervention within 72 hours, and Grade 3 rash in the absence of desquamation with no mucosal involvement), Grade 3 hypertension not able to be controlled by medication, ≥ Grade 3 gastrointestinal perforation, ≥Grade 3 wound dehiscence requiring medical or surgical intervention, any grade thromboembolic event, or any Grade 3 nonhematologic laboratory value if medical intervention was required or the abnormality led to hospitalization. The number of participants in Part 1 with DLTs is reported.
All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included
Posted
Count of Participants
Participants
Up to ~21 days
ID
Title
Description
OG000
Part 1 : Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG002
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG00015
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG0002
Primary
Part 1: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 with AEs is reported
All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6.
OG001
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG002
Part 2: Chemotherapy
Primary
Part 1: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 1 that discontinued study treatment due to an AE is reported.
All randomized participants who received at least 1 dose of study intervention. Per protocol, only participants in part 1 were included
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6.
OG001
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG002
Part 2: Chemotherapy
Primary
Part 2: Overall Survival (OS) in Participants With Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
All randomized participants, whether or not study intervention was administered, with PD-L1 CPS≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the OS analysis.
Posted
Median
95% Confidence Interval
Months
Up to ~41 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Primary
Part 2: OS in All Participants
OS is defined as the time from randomization to death due to any cause. OS is reported by treatment arm for all participants in Part 2.
All randomized participants, whether or not study intervention was administered and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the OS analysis.
Posted
Median
95% Confidence Interval
Months
Up to ~41 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
Primary
Part 2: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
PFS is defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
All randomized participants, whether or not study intervention was administered, with PD-L1 CPS ≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the PFS analysis
Posted
Median
95% Confidence Interval
Months
Up to ~29 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
Primary
Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death from any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. PFS is reported by treatment arm for all participants in Part 2.
All randomized participants, whether or not study intervention was administered and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the PFS analysis
Posted
Median
95% Confidence Interval
Months
Up to ~29 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Chemotherapy
Secondary
Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
ORR is defined as the percentage of participants in the analysis population who have 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) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
All randomized participants, whether or not study intervention was administered, with PD-L1 CPS ≥1 and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the ORR analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~29 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Secondary
Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
ORR is defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or a PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, and assessed by BICR. ORR is reported by treatment arm for all participants in Part 2.
All randomized participants, whether or not study intervention was administered and who had available data for the outcome measure at the time of final analysis. Per protocol, participants in part 1 of the study were not included in the ORR analysis.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to ~29 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Secondary
Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥1
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR is reported by treatment arm for PD-L1 CPS ≥1 participants in Part 2.
All randomized participants who achieved CR or PR with PD-L1 CPS > or =1 and who had available data for the outcome measure at the time of final analysis. Participants were analyzed in the treatment group to which they were randomized. Per protocol, participants in part 1 of the study were not included in the DOR analysis.
Posted
Median
95% Confidence Interval
Months
Up to ~41 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
Secondary
Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
For participants who demonstrated confirmed CR or PR, DOR is defined as the time from the first CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) to subsequent PD or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR is reported by treatment arm for all participants in Part 2.
All randomized participants who achieved CR or PR and who had available data for the outcome measure at the time of final analysis. Participants were analyzed in the treatment group to which they were randomized. Per protocol, participants in part 1 of the study were not included in the DOR analysis.
Posted
Median
95% Confidence Interval
Months
Up to ~41 months
ID
Title
Description
OG000
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
Secondary
Part 2: Number of Participants With AEs
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 with AEs is reported by treatment arm.
Not Posted
Mar 2027
Up to ~41 months
Participants
Secondary
Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants in Part 2 that discontinued study treatment due to an AE is reported by treatment arm.
Not Posted
Mar 2027
Up to ~41 months
Participants
Time Frame
Up to approximately 44 months
Description
All cause-mortality includes all randomized participants, whether or not study intervention was administered. The SAE and other adverse events population includes all randomized participants who received at least 1 dose of study intervention. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to the drug are excluded.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Lenvatinib + Pembrolizumab + Chemotherapy First Course
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
13
15
6
15
14
15
EG001
Part 2: Lenvatinib + Pembrolizumab + Chemotherapy First Course
Participants received lenvatinib administered orally QD in combination with IV pembrolizumab Q6W plus chemotherapy with either CAPOX or chemotherapy with mFOLFOX6. Induction with lenvatinib 8 mg QD plus pembrolizumab (plus chemotherapy (CAPOX or mFOLFOX6) was administered for 2 cycles, followed by consolidation with lenvatinib 20 mg QD plus pembrolizumab for up to 16 cycles. A cycle is 6 weeks (42 days).
333
443
226
441
435
441
EG002
Chemotherapy First Course
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W. A cycle is 6 weeks (42 days).
374
437
137
429
406
429
EG003
Part 1: Pembrolizumab +/-Lenvatinib Second Course
Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experienced radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion
1
1
0
1
0
1
EG004
Part 2: Pembrolizumab +/-Lenvatinib Second Course
Participants treated with pembrolizumab who completed 18 cycles of treatment with SD or better, or participants who attained an investigator-determined CR and received at least 4 cycles of pembrolizumab were eligible for retreatment with up to an additional 9 cycles of pembrolizumab if they experience radiographic disease progression confirmed by BICR after stopping treatment in the initial treatment phase. Lenvatinib was administered per investigator's discretion
0
3
1
3
1
3
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0013 events3 affected441 at risk
EG0023 events3 affected429 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected3 at risk
Autoimmune haemolytic anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events5 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Arteriospasm coronary
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Conduction disorder
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Dihydropyrimidine dehydrogenase deficiency
Congenital, familial and genetic disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Immune-mediated hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cataract
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events6 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00114 events13 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0017 events6 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events5 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0017 events7 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0028 events6 affected429 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastrointestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Ileus paralytic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Incarcerated inguinal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Intestinal ischaemia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0013 events3 affected441 at risk
EG00212 events11 affected429 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events6 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events3 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Oesophageal food impaction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pancreatic pseudocyst
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pneumoperitoneum
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0019 events9 affected441 at risk
EG0029 events9 affected429 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00112 events10 affected441 at risk
EG0027 events7 affected429 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cardiac death
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Death
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events6 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Malaise
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Medical device pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Vascular device occlusion
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cholangitis sclerosing
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Gallbladder rupture
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0023 events3 affected429 at risk
EG003
Hepatic haemorrhage
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Liver injury
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Anaphylactic shock
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Abdominal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0021 events1 affected429 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Endocarditis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Escherichia infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Fungaemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Haematological infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Lung abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Meningitis aseptic
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Neutropenic infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0015 events4 affected441 at risk
EG00211 events10 affected429 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Urinary tract infection staphylococcal
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Eschar
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Pneumonitis chemical
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG00211 events10 affected429 at risk
EG003
SARS-CoV-2 test positive
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0015 events5 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0016 events6 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pathological fracture
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Spinal osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Myelodysplastic syndrome
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Tumour perforation
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cerebral ischaemia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Vagus nerve disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Device occlusion
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0023 events3 affected429 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0023 events3 affected429 at risk
EG003
Immune-mediated nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Haemorrhagic ovarian cyst
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Dysaesthesia pharynx
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Malignant pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0017 events7 affected441 at risk
EG0029 events9 affected429 at risk
EG003
Pulmonary toxicity
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Stevens-Johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Toxic epidermal necrolysis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0023 events3 affected429 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0012 events2 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Embolism arterial
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Embolism venous
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0013 events3 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Shock
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG001249 events159 affected441 at risk
EG002241 events161 affected429 at risk
EG0030 events0 affected1 at risk
EG0040 events0 affected3 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00111 events10 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00131 events31 affected441 at risk
EG0028 events7 affected429 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected15 at risk
EG001139 events127 affected441 at risk
EG0025 events5 affected429 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00127 events25 affected441 at risk
EG00223 events18 affected429 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG001110 events90 affected441 at risk
EG00286 events71 affected429 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00139 events36 affected441 at risk
EG00230 events21 affected429 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00117 events15 affected441 at risk
EG00224 events22 affected429 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG001130 events104 affected441 at risk
EG002115 events88 affected429 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00011 events7 affected15 at risk
EG001339 events201 affected441 at risk
EG002192 events123 affected429 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00130 events29 affected441 at risk
EG0027 events7 affected429 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00125 events22 affected441 at risk
EG00222 events19 affected429 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00127 events27 affected441 at risk
EG00223 events20 affected429 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00111 events10 affected441 at risk
EG00213 events11 affected429 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00014 events8 affected15 at risk
EG001290 events196 affected441 at risk
EG002295 events193 affected429 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected15 at risk
EG00175 events69 affected441 at risk
EG00249 events40 affected429 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00014 events7 affected15 at risk
EG001166 events110 affected441 at risk
EG002147 events105 affected429 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected15 at risk
EG00192 events74 affected441 at risk
EG002100 events69 affected429 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected15 at risk
EG001162 events129 affected441 at risk
EG002104 events79 affected429 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected15 at risk
EG00162 events51 affected441 at risk
EG00230 events26 affected429 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00136 events30 affected441 at risk
EG00228 events25 affected429 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00183 events59 affected441 at risk
EG00255 events36 affected429 at risk
EG003
Temperature intolerance
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Xerosis
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00113 events12 affected441 at risk
EG00213 events11 affected429 at risk
EG003
Liver disorder
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00111 events10 affected441 at risk
EG0024 events4 affected429 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0015 events5 affected441 at risk
EG00212 events10 affected429 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00148 events45 affected441 at risk
EG00244 events43 affected429 at risk
EG003
Candida infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected15 at risk
EG0012 events2 affected441 at risk
EG0024 events2 affected429 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Impetigo
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00151 events32 affected441 at risk
EG00216 events13 affected429 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected15 at risk
EG001128 events94 affected441 at risk
EG002126 events76 affected429 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00185 events55 affected441 at risk
EG00256 events38 affected429 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected15 at risk
EG001159 events109 affected441 at risk
EG002162 events102 affected429 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00130 events19 affected441 at risk
EG00223 events15 affected429 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00141 events33 affected441 at risk
EG00250 events44 affected429 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected15 at risk
EG00186 events52 affected441 at risk
EG00277 events48 affected429 at risk
EG003
Blood calcium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0018 events7 affected441 at risk
EG00212 events7 affected429 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00139 events32 affected441 at risk
EG0028 events7 affected429 at risk
EG003
Blood folate decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0010 events0 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Blood glucose increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected15 at risk
EG00115 events7 affected441 at risk
EG00219 events11 affected429 at risk
EG003
Blood iron decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0014 events4 affected441 at risk
EG0025 events3 affected429 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events2 affected15 at risk
EG0019 events8 affected441 at risk
EG00211 events9 affected429 at risk
EG003
Blood sodium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events2 affected15 at risk
EG00122 events16 affected441 at risk
EG00218 events7 affected429 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected15 at risk
EG00164 events43 affected441 at risk
EG00214 events11 affected429 at risk
EG003
Electrocardiogram QT prolonged
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00113 events9 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0007 events4 affected15 at risk
EG00187 events62 affected441 at risk
EG00286 events57 affected429 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00139 events23 affected441 at risk
EG00232 events24 affected429 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG00011 events7 affected15 at risk
EG001398 events209 affected441 at risk
EG002466 events195 affected429 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG001236 events129 affected441 at risk
EG002353 events180 affected429 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG001174 events148 affected441 at risk
EG002108 events96 affected429 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected15 at risk
EG001233 events114 affected441 at risk
EG002256 events93 affected429 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0008 events5 affected15 at risk
EG001208 events173 affected441 at risk
EG002153 events117 affected429 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00127 events21 affected441 at risk
EG00210 events7 affected429 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00158 events36 affected441 at risk
EG00237 events26 affected429 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00180 events56 affected441 at risk
EG00274 events52 affected429 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00139 events28 affected441 at risk
EG00228 events20 affected429 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG001128 events71 affected441 at risk
EG00261 events44 affected429 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00139 events28 affected441 at risk
EG00220 events15 affected429 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00143 events34 affected441 at risk
EG00225 events25 affected429 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected15 at risk
EG00159 events48 affected441 at risk
EG00218 events18 affected429 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0019 events9 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00139 events36 affected441 at risk
EG00232 events27 affected429 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00111 events9 affected441 at risk
EG0026 events6 affected429 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00132 events27 affected441 at risk
EG0025 events5 affected429 at risk
EG003
Osteonecrosis of jaw
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0012 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0019 events9 affected441 at risk
EG0023 events3 affected429 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00122 events22 affected441 at risk
EG00229 events26 affected429 at risk
EG003
Dysaesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0017 events6 affected441 at risk
EG0029 events7 affected429 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00129 events27 affected441 at risk
EG00245 events41 affected429 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0005 events3 affected15 at risk
EG00131 events26 affected441 at risk
EG00221 events19 affected429 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected15 at risk
EG00189 events73 affected441 at risk
EG002132 events103 affected429 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected15 at risk
EG00112 events7 affected441 at risk
EG00237 events17 affected429 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00136 events27 affected441 at risk
EG00267 events36 affected429 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00161 events54 affected441 at risk
EG00289 events81 affected429 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00132 events31 affected441 at risk
EG00230 events26 affected429 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG001188 events99 affected441 at risk
EG0026 events6 affected429 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0010 events0 affected441 at risk
EG0021 events1 affected429 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00131 events28 affected441 at risk
EG00223 events22 affected429 at risk
EG003
Dysaesthesia pharynx
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0024 events3 affected429 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00125 events24 affected441 at risk
EG0027 events6 affected429 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00126 events25 affected441 at risk
EG00212 events12 affected429 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00125 events23 affected441 at risk
EG00226 events22 affected429 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00123 events16 affected441 at risk
EG00225 events19 affected429 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0013 events3 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Laryngospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0011 events1 affected441 at risk
EG0022 events1 affected429 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00113 events12 affected441 at risk
EG00215 events14 affected429 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00110 events10 affected441 at risk
EG0022 events2 affected429 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected15 at risk
EG0013 events2 affected441 at risk
EG0020 events0 affected429 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0008 events6 affected15 at risk
EG001114 events97 affected441 at risk
EG00271 events60 affected429 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG00169 events51 affected441 at risk
EG00217 events15 affected429 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected15 at risk
EG00167 events53 affected441 at risk
EG00221 events17 affected429 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected15 at risk
EG001218 events146 affected441 at risk
EG00227 events22 affected429 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG00112 events12 affected441 at risk
EG00212 events12 affected429 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected15 at risk
EG0013 events3 affected441 at risk
EG0020 events0 affected429 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
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG00015
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG00015
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG00015
OG0010
OG0020
Title
Denominators
Categories
Title
Measurements
OG0005
Counts
Participants
OG000334
OG001355
Title
Denominators
Categories
Title
Measurements
OG00012.6(10.6 to 14.2)
OG00112.9(11.6 to 14.6)
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
OG000
OG001
Log Rank
.0244
One-sided p-value based on log-rank test stratified by region, ECOG performance status, and chemotherapy type
Hazard Ratio (HR)
0.84
2-Sided
95
0.71
1.00
HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type
Superiority
OG000443
OG001437
Title
Denominators
Categories
Title
Measurements
OG00013.1(11.6 to 14.3)
OG00113.0(11.6 to 14.7)
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
OG000
OG001
Log Rank
0.0330
One-sided p-value based on log-rank test stratified by region, ECOG performance status and chemotherapy type.
Hazard Ratio (HR)
0.87
2-Sided
95
0.75
1.01
HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy
Superiority
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG000333
OG001355
Title
Denominators
Categories
Title
Measurements
OG0007.3(6.8 to 8.3)
OG0016.9(5.8 to 7.2)
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
OG000
OG001
Log Rank
.0012
One-sided p-value based on log-rank test stratified by region, performance status, and chemotherapy type
Hazard Ratio (HR)
0.75
2-Sided
95
0.62
0.90
HR Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type.
Superiority
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG000443
OG001437
Title
Denominators
Categories
Title
Measurements
OG0007.2(6.8 to 8.3)
OG0017.0(6.4 to 7.5)
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
OG000
OG001
Log Rank
0.0019
One-sided p-value based on log-rank test stratified by region, ECOG performance status, and chemotherapy type.
Hazard Ratio (HR)
0.78
2-Sided
95
0.66
0.92
HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by region, ECOG performance status, and chemotherapy type.
Superiority
Units
Counts
Participants
OG000333
OG001355
Title
Denominators
Categories
Title
Measurements
OG00059.5(54.0 to 64.8)
OG00145.4(40.1 to 50.7)
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
OG000
OG001
ORR comparison between groups is based on Miettinen & Nurminen method stratified by region, ECOG performance status, and type of chemotherapy
t-test, 1 sided
<0.0001
Difference in Percentage
14.3
2-Sided
95
6.9
21.5
Superiority
Units
Counts
Participants
OG000443
OG001437
Title
Denominators
Categories
Title
Measurements
OG00058.0(53.3 to 62.7)
OG00143.9(39.2 to 48.7)
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
OG000
OG001
ORR comparison between groups is based on Miettinen & Nurminen method stratified by region, ECOG performance status, and type of chemotherapy
t-test, 1 sided
<0.0001
Difference in Percentage
14.2
2-Sided
95
7.7
20.6
Superiority
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.
Units
Counts
Participants
OG000198
OG001161
Title
Denominators
Categories
Title
Measurements
OG0008.5(7.1 to 12.5)
OG0016.5(5.6 to 7.0)
OG001
Part 2: Chemotherapy
Participants received chemotherapy with either CAPOX Q3W or mFOLFOX6 Q2W.