Platform Trial Evaluating Safety and Efficacy of Ezabenli... | NCT03697304 | Trialant
NCT03697304
Sponsor
Boehringer Ingelheim
Status
Completed
Last Update Posted
Jan 27, 2026Actual
Enrollment
211Actual
Phase
Phase 2
Conditions
Neoplasm Metastasis
Advanced Tumors
Metastatic Solid Tumors
Interventions
Ezabenlimab
BI 754111
BI 836880
Countries
United States
Canada
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03697304
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
1381-0009
Secondary IDs
ID
Type
Description
Link
2018-002344-81
EudraCT Number
Brief Title
Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
Official Title
An Open-label, Phase II, Platform Trial Evaluating Safety and Efficacy of Multiple BI 754091 (Ezabenlimab) Anti-PD-1 Based Combination Regimens in PD-(L)1 naïve and PD-(L)1 Pretreated Patient Populations With Advanced and/or Metastatic Solid Tumours Who Have Had at Least One Line of Systemic Therapy
Acronym
Not provided
Organization
Boehringer IngelheimINDUSTRY
Status Module
Record Verification Date
Jan 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
Mar 19, 2019Actual
Primary Completion Date
Dec 3, 2024Actual
Completion Date
Dec 3, 2024Actual
First Submitted Date
Oct 2, 2018
First Submission Date that Met QC Criteria
Oct 4, 2018
First Posted Date
Oct 5, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 3, 2025
Results First Submitted that Met QC Criteria
Jan 8, 2026
Results First Posted Date
Jan 27, 2026Actual
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
Jan 8, 2026
Last Update Posted Date
Jan 27, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Boehringer IngelheimINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy. This means it may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors.
How long the participants are in the study depends on whether they benefit from treatment and whether they experience unacceptable side effects. The participants are put into different groups. Each group receives BI 754091 in combination with another medicine.
The doctors check whether the tumors shrink or disappear. The doctors also check the general health of the participants.
Detailed Description
Not provided
Conditions Module
Conditions
Neoplasm Metastasis
Advanced Tumors
Metastatic Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
211Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Module C, Cohort 1: GEC patients
Experimental
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 836880
Module C, Cohort 2: 2ary resistance patients
Experimental
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 836880
Module C, Cohort 3: 1ary resistance patients
Experimental
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ezabenlimab
Drug
240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles.
Module A, Cohort 1: GEC patients
Module A, Cohort 2: 2ary resistance patients
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
[Module C] Objective Response (OR)
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
[Module C] Objective Response (OR) - Bayesian Hierarchical Model
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
[Module A] Objective Response (OR)
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Secondary Outcomes
Measure
Description
Time Frame
[Module C] Duration of Response (DoR)
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
Master Protocol:
Provision of signed and dated, written Master informed consent form (ICF) prior to any trial-specific procedures, sampling, or analyses.
Patient ≥18 years of age at the time of signature of the ICF.
Eastern Cooperative Oncology Group (ECOG) score: 0 or 1.
Patient must agree to a pre-treatment biopsy (if archival tissue is not available) and on-treatment tumour biopsy. If archived tumour tissue is available from the last treatment failure, sections may be supplied instead of a pre-treatment biopsy.
Life expectancy of at least 12 weeks after the start of the treatment according to the Investigator's judgement.
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be willing and able to use highly effective methods of birth control (that result in a low failure rate of less than 1% per year when used consistently and correctly) during trial participation and for at least 6 months after the last administration of trial medication. Acceptable highly effective methods of contraception include total sexual abstinence when this is in line with the preferred and usual lifestyle of the study participant (periodic abstinence such as calendar, ovulation, symptothermal, post-ovulation methods and withdrawal are not acceptable methods of contraception), an intrauterine device or intrauterine hormone-releasing system, bilateral tubal ligation, and vasectomised partner (with post-vasectomy proof of absence of sperm). Male patients with partners of childbearing potential must agree to use condoms and ensure their partners are using an additional highly effective method of birth control, during the trial and until at least 6 months after the end of the trial treatment.
Module A:
- Histologically confirmed diagnosis of one of the following cohorts:
Cohort 1 GEC - Locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro oesophageal adenocarcinoma (GEC) (defined as primary tumour localisation below the gastro oesophageal junction (GEJ) with prior anti-PD-1 or anti-PD-L1 based treated tumour.
Cohort 2 Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour with previously anti-PD-1 or anti-PD-L1 based treatment who progressed after achieving benefit
Cohort 3 Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD- 1/PD-L1 based treated tumour without achieving benefit.
All patients must have measurable lesions according to RECIST v1.1
Patient must agree to pre- and on-treatment tumour biopsies. If archived tumour tissue is available from the last treatment failure, sections may be supplied instead of a pre-treatment biopsy.
Module C:
Histologically confirmed diagnosis of one of the following cohorts:
Cohort 1: GEC: Locally advanced, unresectable or metastatic gastric adenocarcinoma or GEC.
Cohort 2: Patients with secondary resistance to anti-PD-1 or anti-PD-L1 based therapy: Any advanced or metastatic solid tumour (excluding NSCLC and melanoma) with previously anti-PD-1 or anti-PD-L1 based treatment which progressed after achieving benefit.
Cohort 3: Patients with primary resistance to anti-PD-1 or anti-PD-L1 based therapy: Select advanced or metastatic solid tumour types with previous anti-PD-1/PD-L1 based treated tumour without achieving benefit.
Cohort 4: Locally advanced, unresectable or metastatic second line or greater, microsatellite stable (MSS) colorectal cancer.
Cohort 5: Advanced Endometrial cancer: Endometrial carcinoma that is pMMR (Mismatch Repair-Proficient)/MSS and is advanced, recurrent, or persistent and has relapsed or is refractory to curative therapy.
All patients must have at least one measurable lesion according to RECIST v1.1
Further inclusion criteria apply
Exclusion Criteria
Master Protocol:
Any investigational treatment anti-tumour treatment within 4 weeks or within 5 half-life periods (whichever is shorter) prior to the initiation of trial treatment.
More than one anti-PD-(L)1-based treatment regimen prior to entering study study, more specifically defined in the modules. Note: once in a trial Module, patients may crossover to different Module if all other eligibility criteria are met.
Major surgery ('major' according to the Investigator's assessment) performed within 12 weeks prior to first trial treatment or planned within 12 months after screening, e.g., hip replacement.
Known history of severe hypersensitivity reactions to other mAbs or known hypersensitivity to the trial drugs or their excipients.
Presence of central nervous system (CNS) metastases, unless treated and asymptomatic and off corticosteroids and/or anticonvulsant therapy for at least 2 weeks prior to start of treatment.
Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of study treatment.
Active autoimmune disease or a documented history of autoimmune disease, except vitiligo or resolved childhood asthma/atopy. Patients who were permanently discontinued from previous anti-PD-1 or anti-PD-L1 therapy because of an immune-related adverse event (irAE).
Module A:
- Previous treatment with an anti-LAG-3 Agent
Module C:
Unresolved, Grade >1 toxicity before the start of treatment with the study drug except for hair loss (alopecia) and hypothyroidism that requires thyroid hormone supplements but is asymptomatic under therapy.
Significant cardiovascular/cerebrovascular diseases (i.e. uncontrolled hypertension, unstable angina, history of infarction within past 6 months, congestive heart failure > New York Heart Association [NYHA] II)
History of severe haemorrhagic or thromboembolic event in the past 12 months
Known inherited predisposition to bleeding or to thrombosis, in the opinion of the investigator - Further exclusion criteria apply
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Recruitment Details
Platform trial evaluating the safety and efficacy of different ezabenlimab (BI 754091) treatment regimens on patients with different types of advanced or metastatic tumors: module C evaluated the efficacy and safety of ezabenlimab (BI 754091) in combination with BI 836880 and module A evaluated the efficacy and safety of ezabenlimab (BI 754091) in combination with BI 754111.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Treated with study drugs
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol: Study Protocol - Master
Jun 12, 2023
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
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential 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
Drug: Ezabenlimab
Drug: BI 836880
Module C, Cohort 4: CRC patients
Experimental
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 836880
Module C, Cohort 5: EC patients
Experimental
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 836880
Module A, Cohort 1: GEC patients
Experimental
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 754111
Module A, Cohort 2: 2ary resistance patients
Experimental
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 754111
Module A, Cohort 3: 1ary resistance patients
Experimental
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Drug: Ezabenlimab
Drug: BI 754111
Module A, Cohort 3: 1ary resistance patients
Module C, Cohort 1: GEC patients
Module C, Cohort 2: 2ary resistance patients
Module C, Cohort 3: 1ary resistance patients
Module C, Cohort 4: CRC patients
Module C, Cohort 5: EC patients
BI 754091
BI 754111
Drug
600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Module A, Cohort 1: GEC patients
Module A, Cohort 2: 2ary resistance patients
Module A, Cohort 3: 1ary resistance patients
BI 836880
Drug
720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Module C, Cohort 1: GEC patients
Module C, Cohort 2: 2ary resistance patients
Module C, Cohort 3: 1ary resistance patients
Module C, Cohort 4: CRC patients
Module C, Cohort 5: EC patients
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
[Module A] Objective Response (OR) - Bayesian Hierarchical Model
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 174.6 weeks.
[Module C] Disease Control (DC)
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
[Module C] Disease Control (DC) - Bayesian Hierarchical Model
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
[Module C] Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation.
From first drug administration until PD or death, whichever occurred earlier. Up to approximately 186.1 weeks.
[Module A] Duration of Response (DoR)
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 63.6 weeks.
[Module A] Disease Control (DC)
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
[Module A] Disease Control (DC) - Bayesian Hierarchical Model
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
[Module A] Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation. Progression free survival was collected, according to the clinical trial protocol until July 2021.
From first drug administration until PD, death, or cut-off date of July 2021, whichever occurred earlier. Up to approximately 104.7 weeks.
Fort Myers
Florida
33901
United States
Florida Cancer Specialists-Saint Petersburg-52979
St. Petersburg
Florida
33705
United States
Florida Cancer Specialists-Sarasota-61670
Tallahassee
Florida
32308
United States
Florida Cancer Specialists - East
West Palm Beach
Florida
33401
United States
Indiana University
Indianapolis
Indiana
46202
United States
Norton Cancer Institute
Louisville
Kentucky
40202
United States
Oklahoma University School of Community Medicine
Oklahoma City
Oklahoma
73104
United States
Tennessee Oncology
Chattanooga
Tennessee
37404
United States
Tennessee Oncology, PLLC-Nashville-52568
Nashville
Tennessee
37203
United States
Medical College Of Wisconsin
Milwaukee
Wisconsin
53226
United States
Cross Cancer Institute (University of Alberta)
Edmonton
Alberta
T6G 1Z2
Canada
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 1Z6
Canada
Beatson West of Scotland Cancer Centre
Glasgow
G12 0YN
United Kingdom
University College Hospital
London
NW1 2BU
United Kingdom
Guy's Hospital
London
SE1 9RT
United Kingdom
Sarah Cannon Research Institute, London
London
W1G 6AD
United Kingdom
FG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
FG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
FG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
FG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
FG005
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
FG006
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
FG007
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
FG00028 subjects
FG00130 subjects
FG00228 subjects
FG00330 subjects
FG00418 subjects
FG0052 subjects
FG00633 subjects
FG00742 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00028 subjects
FG00130 subjects
FG00228 subjects
FG00330 subjects
FG00418 subjects
FG0052 subjects
FG00633 subjects
FG00742 subjects
Type
Comment
Reasons
Other than listed
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Physician Decision
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0030 subjects
FG004
Consent withdrawal
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG004
Adverse Event
FG0004 subjects
FG0014 subjects
FG0022 subjects
FG0034 subjects
FG004
Progressive disease
FG00021 subjects
FG00120 subjects
FG00222 subjects
FG00322 subjects
FG004
Treated set: all patients treated with at least one dose of trial medications.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
BG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
BG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
BG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
BG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
BG005
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
BG006
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
BG007
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00130
BG00228
BG00330
BG00418
BG0052
BG00633
BG00742
BG008211
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00056.5± 10.7
BG00163.2± 13.3
BG00260.6± 10.9
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00110
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
American Indian or Alaska Native
Title
Measurements
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
[Module C] Duration of Response (DoR)
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
Treated set of the module C: all patients treated with at least one dose of trial medications. Only patients that had an unconfirmed OR were included in the analysis.
Posted
Median
Full Range
Weeks
From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 174.6 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
OG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0004
OG0019
OG0022
OG003
Title
Denominators
Categories
Title
Measurements
OG000105.95(12.3 to 174.6)
OG00130.90(6.4 to 81.3)
OG0028.50(8.4 to 8.6)
OG003
Secondary
[Module C] Disease Control (DC)
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Treated set of module C: all patients treated with at least one dose of trial medications.
Posted
Number
95% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
Secondary
[Module C] Disease Control (DC) - Bayesian Hierarchical Model
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
Treated set of module C: all patients treated with at least one dose of trial medications.
Posted
Median
97.5% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
Secondary
[Module C] Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation.
Treated set of module C: all patients treated with at least one dose of trial medications.
Posted
Median
95% Confidence Interval
Weeks
From first drug administration until PD or death, whichever occurred earlier. Up to approximately 186.1 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
OG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
Secondary
[Module A] Duration of Response (DoR)
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on the unconfirmed OR.
Treated set of the module A: all patients treated with at least one dose of trial medications. Only patients that had an unconfirmed OR were included in the analysis.
Posted
Median
Full Range
Weeks
From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 63.6 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG001
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Secondary
[Module A] Disease Control (DC)
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Treated set on module A: all patients treated with at least one dose of trial medications.
Posted
Number
95% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG001
Secondary
[Module A] Disease Control (DC) - Bayesian Hierarchical Model
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study, and PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The estimated DCR is presented by the posterior medians of the bayesian hierarchical model and by the correspondent credible intervals.
Treated set on module A: all patients treated with at least one dose of trial medications.
Posted
Median
97.5% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Secondary
[Module A] Progression-free Survival (PFS)
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation. Progression free survival was collected, according to the clinical trial protocol until July 2021.
Treated set of module A: all patients treated with at least one dose of trial medications.
Posted
Median
95% Confidence Interval
Weeks
From first drug administration until PD, death, or cut-off date of July 2021, whichever occurred earlier. Up to approximately 104.7 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG001
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Primary
[Module C] Objective Response (OR)
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Treated set of the module C: all patients treated with at least one dose of trial medications.
Posted
Number
95% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
OG001
Module C, Cohort 2: 2ary Resistance Patients
Primary
[Module C] Objective Response (OR) - Bayesian Hierarchical Model
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
Treated set of the module C: all patients treated with at least one dose of trial medications.
Posted
Median
97.5% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
ID
Title
Description
OG000
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
Primary
[Module A] Objective Response (OR)
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Treated set of the module A: all patients treated with at least one dose of trial medications.
Posted
Number
95% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG001
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Primary
[Module A] Objective Response (OR) - Bayesian Hierarchical Model
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior medians of the Bayesian hierarchical model and by the correspondent credible intervals.
Treated set of the module A: all patients treated with at least one dose of trial medications.
Posted
Median
97.5% Confidence Interval
percentage of participants
From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
ID
Title
Description
OG000
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG001
Module A, Cohort 2: 2ary Resistance Patients
Time Frame
Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A.
Description
Treated set: all patients treated with at least one dose of trial medications.
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
Module C, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma (GEC) with at least one prior systemic treatment, who failed standard therapy, for whom no further effective options existed, and with no prior PD-1 or PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, in the form of i.v. infusion, on Day 1 of 21-day cycles.
24
28
11
28
27
28
EG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
20
30
18
30
27
30
EG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
22
28
12
28
26
28
EG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
17
30
13
30
29
30
EG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
4
18
11
18
18
18
EG005
Module A, Cohort 1: GEC Patients
Patients with locally advanced, unresectable or metastatic gastric adenocarcinoma or gastro-oesophageal adenocarcinoma, who received prior anti-PD-1 or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
0
2
1
2
2
2
EG006
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
29
33
13
33
33
33
EG007
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
32
42
12
42
41
42
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG0030 affected30 at risk
EG0040 affected18 at risk
EG0050 affected2 at risk
EG0060 affected33 at risk
EG0070 affected42 at risk
BANDAEMIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
IMMUNE THROMBOCYTOPENIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NEUTROPENIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ACUTE LEFT VENTRICULAR FAILURE
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ACUTE MYOCARDIAL INFARCTION
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ATRIAL FIBRILLATION
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
ATRIOVENTRICULAR BLOCK COMPLETE
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
CARDIAC ARREST
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
MYOCARDITIS
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PERICARDIAL EFFUSION
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SUPRAVENTRICULAR TACHYCARDIA
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ADRENAL INSUFFICIENCY
ENDOCRINE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
ABDOMINAL PAIN
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
ASCITES
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
COLITIS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
DIARRHOEA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
GASTROINTESTINAL HAEMORRHAGE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
ILEUS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
IMMUNE-MEDIATED ENTEROCOLITIS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LARGE INTESTINE PERFORATION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NAUSEA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
OESOPHAGEAL OBSTRUCTION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
OESOPHAGEAL PERFORATION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PANCREATITIS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
RECTAL HAEMORRHAGE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
SMALL INTESTINAL OBSTRUCTION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
UPPER GASTROINTESTINAL HAEMORRHAGE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
VOMITING
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
DEATH
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DEVICE RELATED THROMBOSIS
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FACE OEDEMA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
FATIGUE
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
IMPLANT SITE PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LOCALISED OEDEMA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
MALAISE
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
OEDEMA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
PYREXIA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BILE DUCT STENOSIS
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BILE DUCT STONE
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BILIARY OBSTRUCTION
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DRUG-INDUCED LIVER INJURY
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HEPATIC FAILURE
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERBILIRUBINAEMIA
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERTRANSAMINASAEMIA
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
JAUNDICE CHOLESTATIC
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LIVER INJURY
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
COVID-19
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ENCEPHALITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
GASTROINTESTINAL INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
INFECTED FISTULA
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
MENINGITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PHARYNGITIS BACTERIAL
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
PNEUMONIA
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
PNEUMONIA ASPIRATION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0022 affected28 at risk
EG003
SEPSIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
SKIN INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
URINARY TRACT INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
VASCULAR DEVICE INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FALL
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
FEMUR FRACTURE
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
HIP FRACTURE
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HUMERUS FRACTURE
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PROCEDURAL PNEUMOTHORAX
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BLOOD CREATININE INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
TROPONIN I INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DEHYDRATION
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERCALCAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPOKALAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPONATRAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LACTIC ACIDOSIS
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BACK PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BASAL CELL CARCINOMA
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
MYELODYSPLASTIC SYNDROME
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
TUMOUR ASSOCIATED FEVER
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
TUMOUR THROMBOSIS
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
CEREBROVASCULAR ACCIDENT
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ENCEPHALOPATHY
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SOMNOLENCE
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SYNCOPE
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
TRANSIENT ISCHAEMIC ATTACK
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DELIRIUM
PSYCHIATRIC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ACUTE KIDNEY INJURY
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
HAEMATURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYDRONEPHROSIS
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
IMMUNE-MEDIATED NEPHRITIS
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
NEPHRITIS
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
URINARY RETENTION
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
URINARY TRACT OBSTRUCTION
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
PROSTATITIS
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ACUTE RESPIRATORY FAILURE
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ASPIRATION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DYSPNOEA
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
ORGANISING PNEUMONIA
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
PLEURAL EFFUSION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
PNEUMOTHORAX
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
PULMONARY EMBOLISM
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
RESPIRATORY FAILURE
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
DERMATITIS BULLOUS
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
DEEP VEIN THROMBOSIS
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0022 affected28 at risk
EG003
HAEMORRHAGE
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
HYPERTENSION
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 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
EG0004 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG0031 affected30 at risk
EG0041 affected18 at risk
EG0050 affected2 at risk
EG0065 affected33 at risk
EG0076 affected42 at risk
THROMBOCYTOPENIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ATRIAL FIBRILLATION
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ATRIAL TACHYCARDIA
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
TACHYCARDIA
CARDIAC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
EAR DISCOMFORT
EAR AND LABYRINTH DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
EAR PAIN
EAR AND LABYRINTH DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0022 affected28 at risk
EG003
HYPOACUSIS
EAR AND LABYRINTH DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERTHYROIDISM
ENDOCRINE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPOTHYROIDISM
ENDOCRINE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0014 affected30 at risk
EG0023 affected28 at risk
EG003
CONJUNCTIVOCHALASIS
EYE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PERIORBITAL OEDEMA
EYE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
VISION BLURRED
EYE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ABDOMINAL DISTENSION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected30 at risk
EG0020 affected28 at risk
EG003
ABDOMINAL PAIN
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0008 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
ABDOMINAL PAIN UPPER
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
ASCITES
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
COLITIS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
CONSTIPATION
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0013 affected30 at risk
EG0022 affected28 at risk
EG003
DIARRHOEA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0009 affected28 at risk
EG0016 affected30 at risk
EG0025 affected28 at risk
EG003
DYSPEPSIA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
DYSPHAGIA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected30 at risk
EG0023 affected28 at risk
EG003
EPIGASTRIC DISCOMFORT
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FLATULENCE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
GINGIVAL BLEEDING
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
GINGIVAL PAIN
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NAUSEA
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0005 affected28 at risk
EG0017 affected30 at risk
EG0023 affected28 at risk
EG003
ORAL DISCOMFORT
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ORAL PAIN
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
PANCREATITIS ACUTE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
STOMATITIS
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
TOOTHACHE
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
VOMITING
GASTROINTESTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0004 affected28 at risk
EG0016 affected30 at risk
EG0022 affected28 at risk
EG003
ADMINISTRATION SITE REACTION
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
CHEST PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
CHILLS
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
EARLY SATIETY
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FACE OEDEMA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected30 at risk
EG0021 affected28 at risk
EG003
FATIGUE
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0007 affected28 at risk
EG0018 affected30 at risk
EG0028 affected28 at risk
EG003
INFLUENZA LIKE ILLNESS
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
NON-CARDIAC CHEST PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
OEDEMA PERIPHERAL
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0016 affected30 at risk
EG0024 affected28 at risk
EG003
PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PYREXIA
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
SENSATION OF FOREIGN BODY
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
CHOLECYSTITIS
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERTRANSAMINASAEMIA
HEPATOBILIARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
CLOSTRIDIUM DIFFICILE COLITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
COVID-19
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
CYSTITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FOLLICULITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FUNGAL INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
GASTROINTESTINAL VIRAL INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
GROIN ABSCESS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
INFLUENZA
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
ORAL HERPES
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PNEUMONIA
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0022 affected28 at risk
EG003
RHINITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SINUSITIS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0023 affected28 at risk
EG003
SKIN INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
TOOTH ABSCESS
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
URINARY TRACT INFECTION
INFECTIONS AND INFESTATIONS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0013 affected30 at risk
EG0023 affected28 at risk
EG003
CORNEAL ABRASION
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
FALL
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0013 affected30 at risk
EG0021 affected28 at risk
EG003
INFUSION RELATED REACTION
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0004 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
MUSCLE STRAIN
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ROAD TRAFFIC ACCIDENT
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SPINAL COMPRESSION FRACTURE
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
WOUND
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0022 affected28 at risk
EG003
ASPARTATE AMINOTRANSFERASE INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0022 affected28 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BLOOD BILIRUBIN INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BLOOD CREATININE INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0014 affected30 at risk
EG0023 affected28 at risk
EG003
BLOOD UREA INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PLATELET COUNT DECREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
RED BLOOD CELL COUNT INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
VITAMIN D DECREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
WEIGHT DECREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0005 affected28 at risk
EG0012 affected30 at risk
EG0024 affected28 at risk
EG003
WEIGHT INCREASED
INVESTIGATIONS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
DECREASED APPETITE
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0015 affected30 at risk
EG0021 affected28 at risk
EG003
DEHYDRATION
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
HYPERCALCAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERKALAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
HYPERLIPIDAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
HYPERURICAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPOALBUMINAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPOCALCAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HYPOKALAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
HYPOMAGNESAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected30 at risk
EG0020 affected28 at risk
EG003
HYPONATRAEMIA
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
VITAMIN B12 DEFICIENCY
METABOLISM AND NUTRITION DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ARTHRALGIA
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0005 affected28 at risk
EG0015 affected30 at risk
EG0025 affected28 at risk
EG003
BACK PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0005 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
FLANK PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
GROIN PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
MUSCLE SPASMS
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
MUSCULAR WEAKNESS
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0021 affected28 at risk
EG003
MYALGIA
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
NECK PAIN
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0024 affected28 at risk
EG003
PAIN IN EXTREMITY
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
PAIN IN JAW
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
APHASIA
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DIZZINESS
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
DYSGEUSIA
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
HEADACHE
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0014 affected30 at risk
EG0022 affected28 at risk
EG003
MEMORY IMPAIRMENT
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NEUROPATHY PERIPHERAL
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PARALYSIS RECURRENT LARYNGEAL NERVE
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PERIPHERAL SENSORY NEUROPATHY
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
SYNCOPE
NERVOUS SYSTEM DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DEVICE DISLOCATION
PRODUCT ISSUES
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
ANXIETY
PSYCHIATRIC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0022 affected28 at risk
EG003
CONFUSIONAL STATE
PSYCHIATRIC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
DEPRESSION
PSYCHIATRIC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0020 affected28 at risk
EG003
INSOMNIA
PSYCHIATRIC DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
DYSURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
HAEMATURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NEPHROLITHIASIS
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 at risk
EG003
NOCTURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
POLLAKIURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PROTEINURIA
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
URINARY INCONTINENCE
RENAL AND URINARY DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
BENIGN PROSTATIC HYPERPLASIA
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
COUGH
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected30 at risk
EG0020 affected28 at risk
EG003
DYSPHONIA
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
DYSPNOEA
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected30 at risk
EG0025 affected28 at risk
EG003
DYSPNOEA EXERTIONAL
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HAEMOTHORAX
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LARYNGEAL PAIN
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
LOWER RESPIRATORY TRACT CONGESTION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
NASAL CONGESTION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
OROPHARYNGEAL PAIN
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0023 affected28 at risk
EG003
PLEURAL EFFUSION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0013 affected30 at risk
EG0021 affected28 at risk
EG003
RHINITIS ALLERGIC
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
RHINORRHOEA
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
SINUS CONGESTION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
DRY SKIN
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HAND DERMATITIS
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
PRURITUS
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0022 affected28 at risk
EG003
RASH
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0022 affected28 at risk
EG003
RASH ERYTHEMATOUS
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
RASH MACULO-PAPULAR
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0020 affected28 at risk
EG003
RASH PAPULAR
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
RASH PRURITIC
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected28 at risk
EG003
HOT FLUSH
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected28 at risk
EG003
HYPERTENSION
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0003 affected28 at risk
EG0019 affected30 at risk
EG0026 affected28 at risk
EG003
HYPOTENSION
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0023 affected28 at risk
EG003
LYMPHOEDEMA
VASCULAR DISORDERS
MedDRA 27.1
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected28 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
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00228
OG00330
OG00418
Title
Denominators
Categories
Title
Measurements
OG00057.1(37.2 to 75.5)
OG00173.3(54.1 to 87.7)
OG00242.9(24.5 to 62.8)
OG00356.7(37.4 to 74.5)
OG00477.8(52.4 to 93.6)
OG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00228
OG00330
OG00418
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Posterior median = 64.7 97.5% credible interval = (45.4, 77.8)
OG001NA(NA to NA)Posterior median = 70.4 97.5% credible interval = (56.7, 83.8)
OG002NA(NA to NA)Posterior median = 44.7 97.5% credible interval = (29.1, 59.8)
OG003NA(NA to NA)Posterior median = 57.5 97.5% credible interval = (42.1, 71.5)
OG004NA(NA to NA)Posterior median = 82.2 97.5% credible interval = (66.7, 96.1)
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00228
OG00330
OG00418
Title
Denominators
Categories
Title
Measurements
OG00013.4(6.1 to 33.7)
OG00129.1(13.0 to 48.7)
OG0026.1(5.7 to 12.1)
OG00312.6(6.1 to 23.6)
OG00475.0(24.9 to NA)NA = not calculable due to insufficient number of participants with the event.
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0000
OG0013
OG0028
Title
Denominators
Categories
Title
Measurements
OG00112.30(5.7 to 31.4)
OG00228.30(0.1 to 63.6)
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0002
OG00133
OG00242
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 84.2)
OG00142.4(25.5 to 60.8)
OG00245.2(29.8 to 61.3)
OG001
Module A, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0002
OG00133
OG00242
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Posterior median = 10.83 97.5 % credible interval = (1.7, 28.79)
OG001NA(NA to NA)Posterior median = 42.83 97.5 % credible interval = (28.86, 57.14)
OG002NA(NA to NA)Posterior median = 44.18 97.5 % credible interval = (31.57, 57.68)
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0002
OG00133
OG00242
Title
Denominators
Categories
Title
Measurements
OG0005.9(5.7 to NA)NA = not evaluable due to insufficient number of participants with event
OG0016.7(5.9 to 11.9)
OG0028.9(5.7 to 16.9)
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00228
OG00330
OG00418
Title
Denominators
Categories
Title
Measurements
OG00014.3(4.0 to 32.7)
OG00123.3(9.9 to 42.3)
OG0020.0(0.0 to 12.3)
OG0033.3(0.1 to 17.2)
OG00444.4(21.5 to 69.2)
OG001
Module C, Cohort 2: 2ary Resistance Patients
Patients with any advanced or metastatic solid tumor (excluding non-squamous lung cancer, non-small-cell lung cancer, and melanoma) who had received prior anti-PD-1- or anti-PD-L1-based treatment and progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 4 months) and minimum treatment duration of 2 months on the previous anti-PD-1- or anti-PD-L1-based treatment without progressive disease, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along 720 mg of BI 836880 on Day 1, intravenously, on Day1 of 21-day cycles.
OG002
Module C, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumors with prior anti-PD-1- or anti-PD-L1-based treatment without achieving benefit ( stable disease duration of less than 4 months or progressive disease in less than 4 months while on treatment), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG003
Module C, Cohort 4: CRC Patients
Patients with locally advanced, unresectable or metastatic second-line or greater, microsatellite-stable colorectal cancer (CRC) without prior anti-PD-1- or anti-PD-L1-based treatment, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
OG004
Module C, Cohort 5: EC Patients
Patients with advanced endometrial carcinoma (EC), excluding microsatellite instability-high or mismatch repair deficient types, who progressed following one line of chemotherapy, were not eligible for curative surgery or radiation, and had not been previously treated with anti-PD-1- or anti-PD-L1-based therapies, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 720 mg of BI 836880, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00228
OG00330
OG00418
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Posterior median = 11.95 97.5 % credible interval = (3.72, 25.31)
OG001NA(NA to NA)Posterior median = 20.21 97.5 % credible interval = (9.61, 36.1)
OG002NA(NA to NA)Posterior median = 2.75 97.5 % credible interval = (0.17, 10.15)
OG003NA(NA to NA)Posterior median = 5.26 97.5 % credible interval = (0.83, 14.87)
OG004NA(NA to NA)Posterior median = 36.13 97.5 % credible interval = (17.15, 59.63)
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0002
OG00133
OG00242
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 84.2)
OG0016.1(0.7 to 20.2)
OG0029.5(2.7 to 22.6)
Patients with any advanced or metastatic solid tumors who had been previously treated with anti-PD-1 or anti-PD-L1-based therapies, and who progressed after achieving benefit (at least stable disease with a minimum duration of benefit of 6 months) and minimum treatment duration of 2 months without experiencing disease progression, were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
OG002
Module A, Cohort 3: 1ary Resistance Patients
Patients with select advanced or metastatic solid tumor types, who have been previously treated with previous anti-PD-1 or anti-PD-L1-based therapies without achieving benefit (stable disease for less than 6 months or progressive disease in less than 6 months), were administered 240 mg of ezabenlimab (BI 754091), intravenously, on Day 1 of 21-day cycles, along with 600 mg of BI 754111, intravenously, on Day 1 of 21-day cycles.
Units
Counts
Participants
OG0002
OG00133
OG00242
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Posterior median = 9.69 97.5 % credible interval = (0.88, 35.04)
OG001NA(NA to NA)Posterior median = 8.23 97.5 % credible interval = (2.12, 18.91)
OG002NA(NA to NA)Posterior median = 6.67 97.5 % credible interval = (2.3, 16.02)