Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenva... | NCT03797326 | Trialant
NCT03797326
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
May 4, 2026Actual
Enrollment
611Actual
Phase
Phase 2
Conditions
Advanced Solid Tumors
Triple Negative Breast Cancer
Ovarian Cancer
Gastric Cancer
Colorectal Cancer
Glioblastoma
Biliary Tract Cancers
Pancreatic Cancer
Interventions
Pembrolizumab
Lenvatinib
Countries
United States
Argentina
Australia
Canada
Chile
Colombia
France
Germany
Israel
Italy
Russia
South Korea
Spain
Switzerland
Taiwan
Thailand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03797326
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7902-005
Secondary IDs
ID
Type
Description
Link
MK-7902-005
Other Identifier
MSD Protocol Number
E7080-G000-224
Other Identifier
Eisai Protocol Number
LEAP-005
Other Identifier
MSD
2018-003747-37
EudraCT Number
Brief Title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005)
Official Title
A Multicenter, Open-label Phase 2 Study of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) in Previously Treated Subjects With Selected Solid Tumors (LEAP-005)
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
Feb 12, 2019Actual
Primary Completion Date
Oct 28, 2024Actual
Completion Date
Oct 28, 2024Actual
First Submitted Date
Jan 7, 2019
First Submission Date that Met QC Criteria
Jan 7, 2019
First Posted Date
Jan 9, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Oct 8, 2025
Results First Submitted that Met QC Criteria
Oct 31, 2025
Results First Posted Date
Nov 17, 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 13, 2026
Last Update Posted Date
May 4, 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)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) plus lenvatinib 20 mg via oral capsule once a day (QD). Pembrolizumab will be administered for up to 35 cycles (up to 2 years). Lenvatinib will be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Biological: Pembrolizumab
Drug: Lenvatinib
Lenvatinib Monotherapy (Arm 2)
Experimental
Participants receive lenvatinib 24 mg via oral capsule QD, to be administered until progressive disease or unacceptable toxicity (up to at least 2 years).
Drug: Lenvatinib
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Pembrolizumab
Biological
Administered as an IV infusion on Day 1 Q3W.
Pembrolizumab + Lenvatinib (Arm 1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Up to approximately 66 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Up to approximately 66 months
Number of Participants With One or More Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.
Secondary Outcomes
Measure
Description
Time Frame
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment
DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Has a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard systemic therapy has failed in one of the following cohorts: TNBC, Ovarian Cancer, Gastric Cancer, Colorectal Cancer, GBM, BTC (intrahepatic, extrahepatic cholangiocarcinoma and gall bladder cancer; excludes Ampulla of Vater), Pancreatic Cancer
Must have progressed on or since the last treatment
Has measurable disease per RECIST 1.1 (RANO for the GBM cohort) as assessed by the local site investigator/radiology and confirmed by BICR
Has provided a PD-L1 evaluable archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib, or refrain from heterosexual intercourse during this period
Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of study treatment initiation
Has adequate organ function
For Triple Negative Breast Cancer Participants:
Has received one or 2 prior lines of therapy
Has Lactate Dehydrogenase (LDH) <2.0 x Upper Limit of Normal (ULN)
Has locally determined results for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 tumor analyses
For Ovarian Cancer Participants:
- Has primary ovarian cancer and has received 3 prior lines of therapy.
For Gastric Cancer Participants:
- Has received 2 prior lines of therapy. Note: Gastric cancer will include participants with both gastric and gastroesophageal junction (GEJ) adenocarcinoma. Participants with squamous cell carcinoma histology are not eligible
For Colorectal Cancer Participants:
- Has received 2 prior lines of therapy
For GBM Participants:
Has failed initial systemic therapy for newly diagnosed GBM
Have the following time periods elapsed before the projected start of scheduled study treatment: 1) at least 3 weeks from prior surgical resection, 2) at least 1 week from stereotactic biopsy, 3) at least 6 months from completion of prior radiotherapy, 4) at least 4 weeks (or 5 half-lives, whichever is shorter) from any investigational agent, 5) at least 4 weeks from cytotoxic therapy, 6) at least 6 weeks from antibodies, 7) at least 4 weeks (or 5 half-lives, whichever is shorter) from other antitumor therapies and 1 week for cancer vaccines
Be neurologically stable (e.g. without a progression of neurologic symptoms or requiring escalating doses of systemic steroid therapy within last 2 weeks) and clinically stable
Has histologically confirmed World Health Organization (WHO) Grade IV GBM
Has locally determined result for O^6-methylguanine-DNA methyltransferase (MGMT) analysis
For Biliary Tract Cancer Participants:
Has received 1 prior line of therapy
Child-Pugh Score, Class A: well-compensated disease. Child-Pugh Score of 5-6
For Pancreatic Cancer Participants:
Has pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma that is metastatic at enrollment
Has received one or 2 prior lines of therapy
Has received prior therapy with at least 1 (platinum-containing regimen or gemcitabine-containing regimen) but no more than 2 prior systemic therapies for unresectable or metastatic pancreatic cancer
Exclusion Criteria:
Has gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment (applies to all cohorts except the ovarian cancer cohort)
Has radiographic evidence of encasement or invasion of a major blood vessel or of intratumoral cavitation. Participants with portal vein invasion (Vp4), inferior vena cava, or cardiac involvement based on imaging in the BTC cohort are not eligible for enrollment
Has clinical significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study treatment
Has significant cardiovascular impairment within 12 months of the first dose of study treatment, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA), or cardiac arrhythmia associated with hemodynamic instability
Has a history of arterial thromboembolism within 12 months of start of study treatment
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Has a serious nonhealing wound, ulcer or bone fracture
Has had major surgery within 3 weeks prior to first dose of study interventions
Has biologic response modifiers therapy (e.g. granulocyte colony-stimulating factor) within 4 weeks before study entry
Has preexisting ≥Grade 3 gastrointestinal (GI) or non-gastrointestinal fistula
Has received prior therapy with lenvatinib, an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], Tumor necrosis factor receptor superfamily, member 4 [OX 40], tumor necrosis factor receptor superfamily member 9 [CD137])
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study treatment start
If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment
Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live vaccine within 30 days prior to the first dose of study treatment
Has known intolerance to lenvatinib (and/or any of the excipients)
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment
Has known active CNS metastases and/or carcinomatous meningitis
Has tumors involving the brain stem
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has a known history of hepatitis B or known active hepatitis C virus infection
Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant (large organ transplants, stem-cell transplant requiring chronic immunosuppressant therapy necessary to prevent graft rejection)
For GBM Participants:
Has carcinomatous meningitis
Has recurrent tumor greater than 6 cm in maximum diameter
Has tumor primarily localized to the brainstem or spinal cord
Has presence of multifocal tumor, diffuse leptomeningeal or extracranial disease
Has evidence of intratumoral or peritumoral hemorrhage on baseline magnetic resonance imaging (MRI) scan other than those that are grade ≤ 1 and either post-operative or stable on at least 2 consecutive MRI scans
Has received Optune® TTFields within 2 weeks of study intervention
Gonzalez-Martin A, Chung HC, Saada-Bouzid E, Yanez E, Senellart H, Cassier PA, Basu B, Corr BR, Girda E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Lwin Z. Lenvatinib plus pembrolizumab for patients with previously treated advanced ovarian cancer: Results from the phase 2 multicohort LEAP-005 study. Gynecol Oncol. 2024 Jul;186:182-190. doi: 10.1016/j.ygyno.2024.04.011. Epub 2024 May 7.
This study was conducted at 85 centers in 17 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
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
Jan 18, 2024
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
Non-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
Drug
Administered orally once a day during each 21-day cycle.
Lenvatinib Monotherapy (Arm 2)
Pembrolizumab + Lenvatinib (Arm 1)
MK-7902
E7080
LENVIMAâ„¢
Up to approximately 66 months
Number of Participants Who Discontinued From Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.
Up to approximately 62 months
Up to approximately 66 months
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm]). The appearance of one or more new lesions is also considered PD.]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.
Up to approximately 66 months
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, 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. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Up to approximately 66 months
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, 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. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.
Up to approximately 66 months
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
Up to approximately 66 months
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Up to approximately 66 months
Overall Survival (OS)
OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.
Up to approximately 66 months
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib
Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.
Los Angeles
California
90048
United States
University of California Davis Comprehensive Cancer Center ( Site 0005)
Sacramento
California
95817
United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0007)
Aurora
Colorado
80045
United States
University of Florida-Health Cancer Center-Orlando ( Site 0015)
Orlando
Florida
32806
United States
Rutgers Cancer Institute of New Jersey ( Site 0009)
New Brunswick
New Jersey
08901
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0023)
New York
New York
10016
United States
Sanford Fargo Medical Center ( Site 0059)
Fargo
North Dakota
58102
United States
Lehigh Valley Hospital- Cedar Crest ( Site 0047)
Allentown
Pennsylvania
18103
United States
Sanford Cancer Center ( Site 0058)
Sioux Falls
South Dakota
57104
United States
West Cancer Center - East Campus ( Site 0018)
Germantown
Tennessee
38138
United States
Mary Crowley Cancer Research Centers - Medical City Hospital ( Site 0049)
Dallas
Texas
75230
United States
Swedish Medical Center ( Site 0021)
Seattle
Washington
98104
United States
University of Wisconsin Carbone Cancer Center ( Site 0017)
Madison
Wisconsin
53792-0001
United States
Fundacion Favaloro para la Docencia e Investigacion Medica ( Site 2106)
Ciudad Autonoma de Buenos Aires
Buenos Aires
C1078AAI
Argentina
Hospital Aleman ( Site 2100)
Buenos Aires
Buenos Aires F.D.
1118
Argentina
Hospital Britanico de Buenos Aires ( Site 2109)
Ciudad de Buenos Aires
Buenos Aires F.D.
C1280AEB
Argentina
Instituto de Oncologia de Rosario ( Site 2105)
Rosario
Santa Fe Province
S2000KZE
Argentina
CEMIC ( Site 2104)
Buenos Aires
C1431FWO
Argentina
IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2101)
Caba
C1012AAR
Argentina
Royal Brisbane and Women s Hospital ( Site 0901)
Herston
Queensland
4029
Australia
Alfred Health ( Site 0902)
Melbourne
Victoria
3004
Australia
Sir Charles Gairdner Hospital ( Site 0903)
Nedlands
Western Australia
6009
Australia
BC Cancer - Abbotsford ( Site 0200)
Abbotsford British Columbia
British Columbia
V2S 0C2
Canada
CancerCare Manitoba ( Site 0201)
Winnipeg
Manitoba
R3E 0V9
Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0208)
Hamilton
Ontario
L8V 4X2
Canada
Sunnybrook Research Institute ( Site 0207)
Toronto
Ontario
M4N 3M5
Canada
Princess Margaret Cancer Centre ( Site 0202)
Toronto
Ontario
M5G 2M9
Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0210)
Centro Investigación del Cáncer James Lind ( Site 1203)
Temuco
Araucania
4780000
Chile
Fundacion Arturo Lopez Perez ( Site 1201)
Santiago
Region M. de Santiago
7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 1202)
Santiago
Region M. de Santiago
8330024
Chile
Hospital Clinico Universidad de Chile ( Site 1200)
Santiago
Region M. de Santiago
8380456
Chile
Fundacion Colombiana de Cancerologia Clinica Vida ( Site 1105)
MedellÃn
Antioquia
050030
Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 1102)
Bogotá
Bogota D.C.
110321
Colombia
Oncologos del Occidente S.A. ( Site 1106)
Pereira
Risaralda Department
660001
Colombia
Fundacion Valle del Lili ( Site 1101)
Cali
Valle del Cauca Department
760032
Colombia
Centre Antoine Lacassagne ( Site 0404)
Nice
Alpes-Maritimes
06189
France
Centre Leon Berard ( Site 0405)
Lyon
Auvergne
69373
France
Institut Claudius Regaud IUCT Oncopole ( Site 0403)
Toulouse
Haute-Garonne
31059
France
Centre Oscar Lambret ( Site 0401)
Lille
Nord
59000
France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 0402)
Saint-Herblain
Val-de-Marne
44805
France
Institut Gustave Roussy ( Site 0400)
Villejuif
Val-de-Marne
94800
France
Robert Bosch GmbH ( Site 0307)
Stuttgart
Baden-Wurttemberg
70376
Germany
Universitaetsklinikum Regensburg ( Site 0304)
Regensburg
Bavaria
93053
Germany
Universitaetsklinikum Frankfurt ( Site 0306)
Frankfurt am Main
Hesse
60528
Germany
HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0301)
Wiesbaden
Hesse
65199
Germany
SRH Wald-Klinikum Gera GmbH ( Site 0309)
Gera
Thuringia
07548
Germany
Universitaetsklinikum Jena ( Site 0302)
Jena
Thuringia
07740
Germany
Soroka Medical Center ( Site 0601)
Beersheba
8457108
Israel
Rambam Medical Center ( Site 0602)
Haifa
3109601
Israel
Hadassah Ein Kerem Medical Center ( Site 0604)
Jerusalem
9112001
Israel
Chaim Sheba Medical Center ( Site 0600)
Ramat Gan
5262000
Israel
Sourasky Medical Center ( Site 0603)
Tel Aviv
6423906
Israel
Istituto Clinico Humanitas Research Hospital ( Site 1402)
Rozzano
Milano
Italy
Policlinico Le Scotte - A.O. Senese ( Site 1401)
Siena
Tuscany
53100
Italy
Istituto Nazionale Tumori Fondazione Pascale ( Site 1400)
Naples
80131
Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 1403)
Roma
00168
Italy
Arkhangelsk Clinical Oncological Dispensary ( Site 1600)
Arkhangelsk
Arkhangelskaya oblast
163045
Russia
Russian Oncological Research Center n.a. N.N. Blokhin ( Site 1604)
Moscow
Moscow
115478
Russia
Leningrad Regional Oncology Center ( Site 1609)
Saint Petersburg
Sankt-Peterburg
188663
Russia
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1610)
Saint Petersburg
Sankt-Peterburg
197758
Russia
City Clinical Oncology Center ( Site 1608)
Saint Petersburg
Sankt-Peterburg
198255
Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1603)
Kazan'
Tatarstan, Respublika
420029
Russia
Asan Medical Center ( Site 1002)
Songpagu
Seoul
05505
South Korea
Seoul National University Hospital ( Site 1000)
Seoul
03080
South Korea
Severance Hospital Yonsei University Health System ( Site 1001)
Seoul
03722
South Korea
Hospital Clinic i Provincial ( Site 0703)
Barcelona
08036
Spain
Hospital Universitario Gregorio Maranon ( Site 0701)
Madrid
28009
Spain
Clinica Universitaria de Navarra ( Site 0704)
Madrid
28027
Spain
Hospital Ramon y Cajal ( Site 0702)
Madrid
28034
Spain
Inselspital Universitaetsspital Bern ( Site 1705)
Bern
Canton of Bern
3010
Switzerland
Kantonsspital St. Gallen ( Site 1702)
Sankt Gallen
Canton of St. Gallen
9007
Switzerland
Ospedale Regionale di Bellinzona e Valli ( Site 1703)
Bellinzona
Canton Ticino
6500
Switzerland
Kantonsspital Graubuenden ( Site 1704)
Chur
Kanton Graubünden
7000
Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1701)
Geneva
1211
Switzerland
Universitaetsspital Zurich ( Site 1700)
Zurich
8091
Switzerland
National Cheng Kung University Hospital ( Site 3003)
Tainan
704
Taiwan
National Taiwan University Hospital ( Site 3000)
Taipei
10002
Taiwan
Chulalongkorn University ( Site 5001)
Bangkok
Bangkok
10330
Thailand
Ramathibodi Hospital. ( Site 5002)
Bangkok
Bangkok
10400
Thailand
Siriraj Hospital ( Site 5003)
Bangkok
Bangkok
10700
Thailand
Cambridge University Hospitals NHS Trust ( Site 0803)
Cambridge
Cambridgeshire
CB2 0QQ
United Kingdom
Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 0804)
Leicester
Leicestershire
LE1 5WW
United Kingdom
Guy's Hospital ( Site 0806)
London
London, City of
SE1 9RT
United Kingdom
Royal Marsden Hospital (Sutton) ( Site 0800)
London
Surrey
SM3 5PT
United Kingdom
Christie NHS Foundation Trust ( Site 0805)
Manchester
M20 4BX
United Kingdom
Result
Chung HC, Saada-Bouzid E, Longo F, Yanez E, Im SA, Castanon E, Desautels DN, Graham DM, Garcia-Corbacho J, Lopez J, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Korakis I. Lenvatinib plus pembrolizumab for patients with previously treated, advanced, triple-negative breast cancer: Results from the triple-negative breast cancer cohort of the phase 2 LEAP-005 Study. Cancer. 2024 Oct 1;130(19):3278-3288. doi: 10.1002/cncr.35387. Epub 2024 Jun 21.
Ponz-Sarvise M, Rha SY, Gomez-Roca CA, Ortega Moran L, Gill S, Tortora G, Geva R, Saada-Bouzid E, Santoro A, Kim TW, Heudobler D, Dutcus CE, Okpara CE, Ghori R, Zhang Y, Vajdi A, Dettman EJ, Jin F, Groisberg R, Shapira-Frommer R. Lenvatinib plus Pembrolizumab for Patients with Previously Treated Advanced Gastric, Biliary Tract, or Pancreatic Cancer: Results from the Phase II LEAP-005 Study. Cancer Res Commun. 2026 Mar 1;6(3):673-686. doi: 10.1158/2767-9764.CRC-26-0018.
Victoria Ruiz I, Uboha NV, Jamal R, Mejia FC, Ahumada M, Im SA, Gomez-Roca C, Shapira-Frommer R, Perets R, Yanez E, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Castanon E. Lenvatinib Plus Pembrolizumab for Patients With Previously Treated Advanced Colorectal Cancer: Results From the Phase II LEAP-005 Study. Clin Colorectal Cancer. 2026 Jun;25(2):225-238.e2. doi: 10.1016/j.clcc.2026.01.003. Epub 2026 Jan 22.
Rha SY, Castanon E, Gill S, Senellart H, Lopez J, Marquez-Rodas I, Victoria I, Kim TM, Lwin Z, Burger MC, Simonelli M, Cassier PA, Hendifar AE, Ascierto PA, Dutcus C, Okpara CE, Ghori R, Jin F, Groisberg R, Villanueva L. Lenvatinib plus pembrolizumab for patients with previously treated select solid tumors: Results from the phase 2 LEAP-005 study recurrent glioblastoma cohort. Cancer. 2025 Aug 15;131(16):e70015. doi: 10.1002/cncr.70015.
FG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
FG00031 subjects
FG00131 subjects
FG002102 subjects
FG003107 subjects
FG00432 subjects
FG005102 subjects
FG006103 subjects
FG007103 subjects
Treated
FG00031 subjects
FG00131 subjects
FG00299 subjects
FG003105 subjects
FG00430 subjects
FG005101 subjects
FG006102 subjects
FG007103 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00031 subjects
FG00131 subjects
FG002102 subjects
FG003107 subjects
FG00432 subjects
FG005102 subjects
FG006103 subjects
FG007103 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG004
Sponsor Decision
FG0003 subjects
FG0013 subjects
FG0023 subjects
FG0036 subjects
FG004
Death
FG00027 subjects
FG00128 subjects
FG00295 subjects
FG00395 subjects
FG004
Enrolled in error
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00131
BG002102
BG003107
BG00432
BG005102
BG006103
BG007103
BG008611
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00031
BG00131
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0012
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Secondary
Disease Control Rate (DCR) Per RECIST 1.1 by Investigator Assessment
DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]). Disease Control rate per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00031
OG00131
Title
Denominators
Categories
Title
Measurements
OG00051.6(33.1 to 69.8)
OG00177.4(58.9 to 90.4)
Secondary
Disease Control Rate (DCR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
DCR was defined per RECIST 1.1 as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm]). The appearance of one or more new lesions is also considered PD.]). For participants with GBM, response was assessed according to RANO criteria whereby overall response was based on both radiographic response (CR: disappearance of all target lesions, PR: sum of products of diameters [SPD] decreased by ≥ 50% from baseline value and SD: SPD <50% decreased from baseline, but <25% increased from nadir) and clinical performance status with steroid dose information. The DCR as assessed by BICR is presented.
All allocated participants who received at least 1 dose of study intervention. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 66 months
ID
Title
Description
OG000
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Secondary
Duration of Response (DOR) Per RECIST 1.1 by Investigator Assessment
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, 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. Duration of response per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response.
Posted
Median
95% Confidence Interval
Months
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Secondary
Duration of Response (DOR) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, 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. For participants with GBM, response will be assessed according to RANO criteria whereby overall RANO response is based on both radiographic response (CR: disappearance of all target lesions, PR: SPD decreased by ≥ 50% from baseline value) and clinical performance status with steroid dose information. DOR assessments were based on blinded central imaging review with confirmation.
All allocated participants who received at least 1 dose of study intervention and had confirmed complete response or partial response. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
Posted
Median
95% Confidence Interval
Months
Up to approximately 66 months
ID
Title
Description
OG000
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Secondary
Progression-Free Survival (PFS) Per RECIST 1.1 by Investigator Assessment
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The percentage of participants who experienced PFS per RECIST 1.1 by investigator assessment is presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention.
Posted
Median
95% Confidence Interval
Months
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Secondary
Progression-Free Survival (PFS) Per RECIST 1.1 or RANO Criteria (GBM Only) by BICR
PFS was defined as the time from date of study treatment to the first documented progressive disease (PD) based on RECIST 1.1 (or RANO for GBM participants), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. For participants with GBM, either radiological progression or clinical deterioration (not attributable to a nontumor-related cause) qualifies as PD. The percentage of participants who experienced PFS per RECIST 1.1 or RANO by BICR is presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention.
Posted
Median
95% Confidence Interval
Months
Up to approximately 66 months
ID
Title
Description
OG000
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Secondary
Overall Survival (OS)
OS was defined as the time from the date of study treatment to the date of death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The OS for all participants is presented.
All allocated participants who received at least 1 dose of study intervention.
Posted
Median
95% Confidence Interval
Months
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Secondary
Area Under the Concentration Curve at Steady State (AUCss) of Lenvatinib
Blood samples were collected at pre-specified timepoints to determine the AUCss in participants receiving Lenvatinib (Lenva) co-administered with Pembrolizumab (Pembro). AUCss was defined as a measure of drug exposure that was calculated as the product of plasma drug concentration and time after drug administration at steady state. AUCss determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Noncompartmental analysis was used to calculate AUC0ss for each participant. Mean and standard deviation of AUCss were calculated for each cohort. As specified in the protocol, pharmacokinetic analysis was not planned or conducted in Cohorts D2 and G.
All allocated participants who received at least 1 dose of study intervention and had data available for this endpoint.
Posted
Mean
Standard Deviation
ng*hr/mL
Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose and 2-12 hours post-dose; Cycle 2 Day 1: pre-dose, 0.5-4 hours, and 6-10 hours post-dose (up to approximately 23 days). Each cycle is 21 days.
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Primary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Investigator Assessment
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 by investigator assessment was presented. Per protocol, only data for Cohorts A and B were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Primary
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or Response Assessment in Neuro-Oncology (RANO) Criteria (for Glioblastoma Multiforma [GBM] Only), by Blinded Independent Central Review (BICR)
ORR was defined as the percentage of participants who had a best overall response of either Complete Response (CR): Disappearance of all target lesions or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions as assessed by RECIST 1.1. For participants with GBM, response was assessed according to RANO criteria whereby ORR was defined as the percentage of participants who had a best overall response of either Complete response (CR): Disappearance of all target lesions or Partial response (PR): sum of products of diameters decreased by ≥50% from baseline value. The percentage of participants who experienced a CR or PR as assessed by RECIST 1.1 or RANO by BICR was presented. Per protocol, only data for Cohorts C, D1, D2, E, F, and G were presented for this endpoint.
All allocated participants who received at least 1 dose of study intervention.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 66 months
ID
Title
Description
OG000
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Primary
Number of Participants With One or More Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with at least one or more AE is presented.
All allocated participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 66 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Primary
Number of Participants Who Discontinued From Study Treatment Due to an AE
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued from study treatment due to an AE is presented.
All allocated participants who received at least 1 dose of study intervention.
Posted
Count of Participants
Participants
Up to approximately 62 months
ID
Title
Description
OG000
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Time Frame
Up to approximately 66 months
Description
All-Cause Mortality included all randomized participants. Serious and Other adverse events (AEs) included all randomized participants who received at least one dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study intervention. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study intervention were 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
Cohort A: Triple Negative Breast Cancer (Lenva + Pembro)
Participants received Pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenvatinib (lenva) 20 mg via oral capsule once a day (QD) up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
27
31
16
31
30
31
EG001
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
28
31
19
31
31
31
EG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
97
102
57
99
95
99
EG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
97
107
55
105
103
105
EG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
99
102
30
101
98
101
EG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
98
103
62
102
100
102
EG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
101
103
49
103
101
103
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG0031 events1 affected105 at risk
EG0040 events0 affected30 at risk
EG0050 events0 affected101 at risk
EG0060 events0 affected102 at risk
EG0070 events0 affected103 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cardiomyopathy
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypersensitivity myocarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Left ventricular dysfunction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypophysitis
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Abdominal wall haematoma
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events1 affected99 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Duodenal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Duodenal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Gastric perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Gastrointestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0023 events2 affected99 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Immune-mediated pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Intestinal dilatation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Intestinal pseudo-obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Jejunal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Oesophageal perforation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Oesophageal stenosis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Death
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
General physical health deterioration
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Biliary tract disorder
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cholangitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Immune-mediated hepatitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Jaundice
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Jaundice cholestatic
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Bacteroides infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Biliary sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Biliary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Infective aneurysm
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Periorbital cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0023 events2 affected99 at risk
EG003
Pneumonia aspiration
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Scrotal infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Septic shock
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Intestinal anastomosis complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Stoma site haemorrhage
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Stomal hernia
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Urinary tract stoma complication
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Transaminases increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Leukoencephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myasthenic syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Paraneoplastic neurological syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Spinal cord compression
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Spinal cord haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Status epilepticus
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Syncope
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vascular encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vasogenic cerebral oedema
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Wernicke's encephalopathy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Device dislocation
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Stent malfunction
Product Issues
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Nephrotic syndrome
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Lung consolidation
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Loss of personal independence in daily activities
Social circumstances
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Assisted suicide
Surgical and medical procedures
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Haemorrhage
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hypertensive urgency
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hypovolaemic shock
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Iliac artery occlusion
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vasculitis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Venous haemorrhage
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 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
EG0009 events5 affected31 at risk
EG0015 events4 affected31 at risk
EG00220 events17 affected99 at risk
EG00319 events12 affected105 at risk
EG0048 events6 affected30 at risk
EG0058 events3 affected101 at risk
EG00613 events11 affected102 at risk
EG00717 events15 affected103 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events2 affected31 at risk
EG0027 events6 affected99 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0013 events2 affected31 at risk
EG00214 events10 affected99 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0012 events2 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG00015 events14 affected31 at risk
EG00114 events14 affected31 at risk
EG00225 events25 affected99 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0016 events5 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events5 affected31 at risk
EG00111 events10 affected31 at risk
EG00219 events17 affected99 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG00110 events8 affected31 at risk
EG0027 events7 affected99 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0015 events4 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected31 at risk
EG00111 events11 affected31 at risk
EG00218 events17 affected99 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00034 events14 affected31 at risk
EG00138 events19 affected31 at risk
EG00240 events30 affected99 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0019 events8 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected31 at risk
EG0013 events2 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events3 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected31 at risk
EG0014 events3 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00017 events13 affected31 at risk
EG00121 events15 affected31 at risk
EG00232 events31 affected99 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0016 events6 affected31 at risk
EG0029 events9 affected99 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events3 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00018 events10 affected31 at risk
EG00122 events13 affected31 at risk
EG00217 events15 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0008 events7 affected31 at risk
EG0018 events6 affected31 at risk
EG00234 events30 affected99 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG0011 events1 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected31 at risk
EG00116 events14 affected31 at risk
EG00222 events21 affected99 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 27.1
Systematic Assessment
EG00010 events7 affected31 at risk
EG00110 events10 affected31 at risk
EG00210 events9 affected99 at risk
EG003
Oedema peripheral
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected31 at risk
EG0015 events5 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Peripheral swelling
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0013 events3 affected31 at risk
EG0029 events8 affected99 at risk
EG003
Cystitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events2 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected31 at risk
EG00110 events5 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG00012 events5 affected31 at risk
EG00117 events7 affected31 at risk
EG00218 events12 affected99 at risk
EG003
Amylase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0029 events7 affected99 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG00011 events6 affected31 at risk
EG00117 events8 affected31 at risk
EG00225 events18 affected99 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0017 events6 affected31 at risk
EG00214 events14 affected99 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0028 events7 affected99 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected31 at risk
EG0027 events5 affected99 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Blood magnesium decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0011 events1 affected31 at risk
EG0024 events2 affected99 at risk
EG003
Blood sodium increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0006 events1 affected31 at risk
EG0013 events3 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Blood urea increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0012 events2 affected31 at risk
EG0027 events7 affected99 at risk
EG003
Lipase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0014 events3 affected31 at risk
EG0029 events8 affected99 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG00010 events5 affected31 at risk
EG0011 events1 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0007 events5 affected31 at risk
EG0013 events3 affected31 at risk
EG00210 events9 affected99 at risk
EG003
Platelet count increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Protein total decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0024 events3 affected99 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0009 events8 affected31 at risk
EG0018 events7 affected31 at risk
EG00215 events15 affected99 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG00012 events9 affected31 at risk
EG00120 events15 affected31 at risk
EG00231 events30 affected99 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0015 events4 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0006 events3 affected31 at risk
EG0013 events1 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0025 events4 affected99 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0004 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0015 events4 affected31 at risk
EG0029 events9 affected99 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0016 events3 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0005 events4 affected31 at risk
EG00117 events5 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0028 events8 affected99 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG00018 events11 affected31 at risk
EG00117 events11 affected31 at risk
EG00213 events10 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected31 at risk
EG0014 events4 affected31 at risk
EG00214 events13 affected99 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events3 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG0014 events2 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0010 events0 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected31 at risk
EG0017 events7 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0012 events2 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0012 events2 affected31 at risk
EG0026 events4 affected99 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Aphasia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0015 events5 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0015 events4 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG00016 events10 affected31 at risk
EG00116 events10 affected31 at risk
EG0028 events7 affected99 at risk
EG003
Tremor
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events3 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0016 events5 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG0011 events1 affected31 at risk
EG0025 events5 affected99 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0013 events3 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0008 events6 affected31 at risk
EG00118 events13 affected31 at risk
EG00213 events12 affected99 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0006 events6 affected31 at risk
EG0015 events4 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected31 at risk
EG0013 events3 affected31 at risk
EG00220 events20 affected99 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected31 at risk
EG0015 events4 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG0012 events2 affected31 at risk
EG0028 events8 affected99 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0023 events3 affected99 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected31 at risk
EG0013 events3 affected31 at risk
EG0026 events6 affected99 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected31 at risk
EG0010 events0 affected31 at risk
EG0021 events1 affected99 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected31 at risk
EG0016 events6 affected31 at risk
EG00210 events10 affected99 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected31 at risk
EG0017 events6 affected31 at risk
EG00213 events13 affected99 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected31 at risk
EG0015 events5 affected31 at risk
EG0024 events4 affected99 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0012 events2 affected31 at risk
EG0020 events0 affected99 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG00025 events16 affected31 at risk
EG00128 events21 affected31 at risk
EG00242 events37 affected99 at risk
EG003
Hypotension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected31 at risk
EG0011 events1 affected31 at risk
EG0022 events2 affected99 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with ICMJE authorship requirements.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D005833
Genital Neoplasms, Female
D014565
Urogenital Neoplasms
D000091662
Genital Diseases
D004700
Endocrine System Diseases
D006058
Gonadal Disorders
D005770
Gastrointestinal Neoplasms
D004067
Digestive System Neoplasms
D004066
Digestive System Diseases
D005767
Gastrointestinal Diseases
D013272
Stomach Diseases
D007414
Intestinal Neoplasms
D003108
Colonic Diseases
D007410
Intestinal Diseases
D012002
Rectal Diseases
D001254
Astrocytoma
D005910
Glioma
D018302
Neoplasms, Neuroepithelial
D017599
Neuroectodermal Tumors
D009373
Neoplasms, Germ Cell and Embryonal
D009370
Neoplasms by Histologic Type
D009375
Neoplasms, Glandular and Epithelial
D009380
Neoplasms, Nerve Tissue
D001660
Biliary Tract Diseases
D010182
Pancreatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C582435
pembrolizumab
C531958
lenvatinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0062 subjects
FG0073 subjects
0 subjects
FG0053 subjects
FG0063 subjects
FG0072 subjects
30 subjects
FG00596 subjects
FG00697 subjects
FG00798 subjects
2 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
Between 18 and 65 years
BG00025
BG00118
BG00268
BG00371
BG00425
BG00583
BG00652
BG00756
BG008398
>=65 years
BG0006
BG00113
BG00234
BG00336
BG0047
BG00519
BG00651
BG00747
BG008213
30
BG00332
BG00414
BG00538
BG00653
BG00742
BG008271
Male
BG0000
BG0010
BG00272
BG00375
BG00418
BG00564
BG00650
BG00761
BG008340
17
BG00319
BG0049
BG00513
BG0069
BG00716
BG00891
Not Hispanic or Latino
BG00019
BG00123
BG00264
BG00377
BG00423
BG00573
BG00676
BG00786
BG008441
Unknown or Not Reported
BG0006
BG0016
BG00221
BG00311
BG0040
BG00516
BG00618
BG0071
BG00879
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0005
BG0014
BG00211
BG00317
BG0042
BG00517
BG00618
BG0078
BG00882
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0081
Black or African American
BG0000
BG0010
BG0022
BG0034
BG0042
BG0050
BG0061
BG0072
BG00811
White
BG00022
BG00123
BG00270
BG00371
BG00425
BG00572
BG00671
BG00790
BG008444
More than one race
BG0000
BG0010
BG0022
BG0034
BG0043
BG0051
BG0060
BG0073
BG00813
Unknown or Not Reported
BG0004
BG0014
BG00217
BG00311
BG0040
BG00511
BG00613
BG0070
BG00860
OG001
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG005
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00099
OG001105
OG00230
OG003101
OG004102
OG005103
Title
Denominators
Categories
Title
Measurements
OG00053.5(43.2 to 63.6)
OG00152.4(42.4 to 62.2)
OG00256.7(37.4 to 74.5)
OG00357.4(47.2 to 67.2)
OG00464.7(54.6 to 73.9)
OG00537.9(28.5 to 48.0)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG0007
OG0018
Title
Denominators
Categories
Title
Measurements
OG00022.9(4.2 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG00115.3(6.4 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG001
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG005
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00015
OG00115
OG0022
OG00322
OG00418
OG0058
Title
Denominators
Categories
Title
Measurements
OG0008.3(4.2 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG0018.3(4.2 to 18.5)
OG002NA(NA to NA)NA = Median, Lower and Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG0034.6(3.2 to 15.6)
OG0046.2(4.2 to 7.1)
OG0055.8(2.7 to NA)NA = Upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Units
Counts
Participants
OG00031
OG00131
Title
Denominators
Categories
Title
Measurements
OG0004.2(1.7 to 6.3)
OG0016.1(4.1 to 9.4)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG005
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00099
OG001105
OG00230
OG003101
OG004102
OG005103
Title
Denominators
Categories
Title
Measurements
OG0003.5(2.3 to 4.1)
OG0013.4(2.1 to 4.1)
OG0023.4(2.1 to 4.8)
OG0033.0(2.8 to 4.1)
OG0044.1(3.6 to 5.9)
OG0052.1(2.1 to 3.1)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00031
OG00131
OG00299
OG003105
OG00430
OG005101
OG006102
OG007103
Title
Denominators
Categories
Title
Measurements
OG00011.4(4.1 to 21.7)
OG00121.3(11.7 to 32.3)
OG0024.7(3.8 to 6.1)
OG0038.7(7.0 to 10.0)
OG0047.9(5.6 to 14.9)
OG0058.6(7.4 to 10.8)
OG0067.9(5.6 to 9.5)
OG0074.3(3.8 to 5.4)
Cohort B: Ovarian Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG005
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00030
OG00131
OG00293
OG003104
OG004100
OG005100
Title
Denominators
Categories
Title
Measurements
OG0003253± 1029
OG0013145± 984
OG0022392± 803
OG0032994± 1143
OG0042617± 804
OG0052886± 838
Units
Counts
Participants
OG00031
OG00131
Title
Denominators
Categories
Title
Measurements
OG00022.6(9.6 to 41.1)
OG00125.8(11.9 to 44.6)
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG002
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG005
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00099
OG001105
OG00230
OG003101
OG004102
OG005103
Title
Denominators
Categories
Title
Measurements
OG00015.2(8.7 to 23.8)
OG00114.3(8.2 to 22.5)
OG0026.7(0.8 to 22.1)
OG00321.8(14.2 to 31.1)
OG00417.6(10.8 to 26.4)
OG0057.8(3.4 to 14.7)
OG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Units
Counts
Participants
OG00031
OG00131
OG00299
OG003105
OG00430
OG005101
OG006102
OG007103
Title
Denominators
Categories
Title
Measurements
OG00031
OG00131
OG00297
OG003104
OG00430
OG005101
OG006102
OG007103
OG002
Cohort C: Gastric Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG003
Cohort D1: Colorectal Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG004
Cohort D2: Colorectal Cancer (Lenva)
Participants received Lenva 24 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG006
Cohort F: Biliary Tract Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.
OG007
Cohort G: Pancreatic Cancer (Lenva + Pembro)
Participants received Pembro 200 mg via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (up to 2 years) PLUS Lenva 20 mg via oral capsule QD up to at least 2 years. Participants continued study intervention until progressive disease or unacceptable toxicity.