An Open-Label Extension Study of GSK3511294 (Depemokimab)... | NCT05243680

ID	Type	Description	Link
2023-505203-23-01	Other Identifier	EU-CT

Status Module

Name	Class
IQVIA Pty Ltd	INDUSTRY

Label	Type	Description	Intervention Names
Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)	Experimental		Biological: GSK3511294 (Depemokimab)

Name	Type	Description	Arm Group Labels	Other Names
GSK3511294 (Depemokimab)	Biological	GSK3511294 (Depemokimab) will be administered using a pre-filled safety syringe.	Participants diagnosed with asthma receiving GSK3511294 (Depemokimab)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.	Up to Week 56
Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)	Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.	Up to Week 52
Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies	Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.	Up to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Annualized Rate of Clinically Significant Exacerbations	Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) (such as intramuscular [IM], intravenous [IV] or oral) and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participants who completed the double-blind study intervention treatment during Study 206713 or Study 213744.
Participants capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion criteria:

Clinically significant change in health status during Study 206713 or Study 213744 which in the opinion of the investigator would make the participant unsuitable for participation in this study.
A current malignancy or a malignancy that developed during Study 206713 or Study 213744 (participants who had localized carcinoma of the skin that was resected for cure will not be excluded).
Participants who have other clinically significant medical conditions uncontrolled with Standard of Care (SoC) therapy not associated with Asthma, for example (e.g.), uncontrolled cardiovascular disease or ongoing active infectious disease which in the opinion of the investigator makes them unsuitable for the study.
Participants with known parasitic (helminth) infections within 6 months prior to Visit 1 will be excluded from the study or required to be adequately treated for helminth infections before initiation of GSK3511294.
Participants who meet the following based on results of Week 48 assessment from Study 206713 or Study 213744 or from a later result:
1. Alanine aminotransferase (ALT) greater than (>)2 times upper limit of normal (ULN).
2. Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<] 35 percent [%]).
3. Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrolment.
Electrocardiogram (ECG) assessment: QTc corrected by Fridericia's formula (QTcF) greater than or equal to (>=)450 milliseconds (msec) or QTcF >=480 msec for participants with Bundle Branch Block at Visit 1.
Current smokers.
Participants with allergy/intolerance to the excipients of GSK3511294, a monoclonal antibody, or biologic.
Participants who are pregnant or breastfeeding. Participants should not be enrolled if they plan to become pregnant during the time of study participation.
Participants who for any reason permanently discontinued study treatment in the previous study 206713/213744 will be excluded from this study.
Other investigational product/clinical study:
1. Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, prior to the first dose, other than Study 206713/213744 study treatment. The term "investigational" applies to any drug not approved for sale for the disease/indication to treat in the country in which it is being used or investigational formulations of marketed products.
2. Participants who are currently participating in any other interventional clinical study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Mobile	Alabama	36608	United States
GSK Investigational Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 16, 2025	Nov 18, 2025

Arm/Group Information

ID	Title	Description
BG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.
BG001	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Safety Analysis Set included all participants who received at least one dose of open-label GSK3511294 excluding the participants from the sites with data integrity and GCP violation issues.

Posted

Count of Participants

Participants

Up to Week 56

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.
OG001	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.

Units	Counts
Participants	OG000210 OG001419

Title

Denominators

Categories

Any AEs

Title	Measurements
	OG000147 OG001301

Any SAEs

Title	Measurements
	OG000

Primary

Number of Participants With Worst Case Post-Baseline Positive Anti-GSK3511294 Antibodies (ADA)

Serum samples were collected for the determination of anti-GSK3511294 antibodies (ADA) using a validated electro-chemiluminescent immunoassay. The assay involved screening, confirmation and titration assays. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Confirmed positive ADA samples were further characterized in the titration assay to quasi-quantitate the amount of ADA in the sample and were also further characterized in the Neutralizing antibody (Nab) assay. A participant was considered positive ADA if they had at least one positive worst case post-Baseline ADA result. Number of participants with worst case post-Baseline positive anti-GSK3511294 antibodies are presented.

Safety Analysis Set included all participants who received at least one dose of open-label GSK3511294 excluding the participants from the sites with data integrity and GCP violation issues. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Primary

Number of Participants With Worst Case Post-Baseline Positive Neutralizing Antibodies

Blood samples were collected for the determination of positive neutralizing antibodies. Neutralizing antibody (NAb) test was only carried out on samples that were positive in the confirmatory binding antibody assay. A participant was considered positive for NAb if they had at least one positive worst case post-Baseline neutralizing antibody result. Number of participants with worst case post-Baseline positive neutralizing antibodies are presented.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.
OG001	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study

Secondary

Annualized Rate of Clinically Significant Exacerbations

Clinically significant exacerbations recorded were defined as worsening of asthma requiring the use of systemic corticosteroids (CS) (such as intramuscular [IM], intravenous [IV] or oral) and/or hospitalization and/or Emergency Department (ED) visit. For all participants, IV or oral steroids (e.g., prednisone) for at least 3 days or a single IM corticosteroid dose is required. For participants on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required. Exacerbations recorded in the electronic case report form (eCRF) were considered as verified clinically significant exacerbations and included in the analysis. Exacerbations separated by less than 7 days was treated as a continuation of the same exacerbation.

Safety Analysis Set included all participants who received at least one dose of open-label GSK3511294 excluding the participants from the sites with data integrity and GCP violation issues.

Posted

Mean

95% Confidence Interval

Exacerbation per participant per year

Up to Week 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Secondary

Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score

The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma symptom control. The questions are designed to be self-completed by the participant. The 5 questions enquired to recall how their asthma had been during the previous week and to respond about the frequency and/or severity of symptoms (nocturnal awakening, waking in the morning, activity limitation, shortness of breath and wheezing). The overall ACQ-5 response option is the mean score of all 5 questions representing 0 with no impairment/limitation and 6 as total impairment/ limitation. Higher scores indicated more limitations and lower score with better asthma control. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Posted

Least Squares Mean

Standard Error

Scores on a Scale

Baseline (Day 1), Weeks 4, 8, 12, 20, 26, 28, 32, 40 and 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Secondary

Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Total Score at Weeks 26 and 52

The SGRQ is a 50-item patient-reported outcome tool used to measure Quality of Life in participants with airway obstruction diseases. The questions are designed to be self-completed by the participant. The total score was calculated by the symptom score, activity and impact score; and summarizing the impact of the disease on overall health status on 0-100 rating scale. Scores are expressed as a percentage of overall impairment where 100 representing worst possible health status and 0 indicating best possible health status. Higher scores indicating greater impairment of quality of life. Baseline was the value at Day 1 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Posted

Least Squares Mean

Standard Error

Scores on a Scale

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

Secondary

Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) at Weeks 26 and 52

Forced Expiratory Volume in One Second (FEV1) is a measure of lung function and defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline was the value at Day 1 of the study. Change from Baseline in pre-bronchodilator FEV1 was defined as value at the indicated time point minus Baseline value. Number of participants with analyzable data for one or more timepoints.

Posted

Least Squares Mean

Standard Error

Liters (L)

Baseline (Day 1), Weeks 26 and 52

ID	Title	Description
OG000	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.

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	Placebo in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received placebo in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 milligram (mg) dose of GSK3511294 as a subcutaneous (SC) injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma standard of care (SOC) treatment throughout the study.	0	210	21	210	82	210
EG001	GSK3511294 in Previous Studies/GSK3511294 100 mg SC in Extension Study	Participants who had previously received GSK3511294 100 mg subcutaneously (SC) in the 206713 (NCT04719832) and 213744 (NCT04718103) were enrolled in this extension study. Participants received a 100 mg dose of GSK3511294 as a SC injection once on Week 0 (visit 1) and on Week 26 (visit 6) in this extension study. Participants were to be maintained on their existing Baseline maintenance asthma SOC treatment throughout the study.	0	419	38	419	178	419

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Adams-Stokes syndrome	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0003 events2 affected210 at risk EG0012 events2 affected419 at risk
Atrial flutter	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Adrenal mass	Endocrine disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Medical device site haematoma	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Bronchitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
COVID-19	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0002 events2 affected210 at risk EG0010 events0 affected419 at risk
Cellulitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0012 events2 affected419 at risk
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0002 events2 affected210 at risk EG0013 events3 affected419 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected419 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0002 events2 affected210 at risk EG0011 events1 affected419 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected419 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Cerebral infarction	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0011 events1 affected419 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Lacunar infarction	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Seizure	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0003 events3 affected210 at risk EG0015 events5 affected419 at risk
Chronic rhinosinusitis with nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Bursitis infective	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Cardiac failure	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Hip deformity	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Colitis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected210 at risk EG0011 events1 affected419 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected210 at risk EG0010 events0 affected419 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bronchitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0007 events7 affected210 at risk EG00123 events22 affected419 at risk
COVID-19	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00015 events15 affected210 at risk EG00129 events28 affected419 at risk
Influenza	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0007 events7 affected210 at risk EG00110 events9 affected419 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0008 events6 affected210 at risk EG00116 events13 affected419 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00027 events21 affected210 at risk EG00173 events58 affected419 at risk
Pharyngitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00010 events8 affected210 at risk EG00117 events15 affected419 at risk
Respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0004 events3 affected210 at risk EG00121 events16 affected419 at risk
Rhinitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00011 events8 affected210 at risk EG00116 events13 affected419 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG00033 events25 affected210 at risk EG00160 events45 affected419 at risk
Headache	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0008 events7 affected210 at risk EG00122 events18 affected419 at risk

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases