Efficacy, Safety, and Immunogenicity of a Plant-Derived Q... | NCT03301051

Label	Type	Description	Intervention Names
Quadrivalent VLP Vaccine	Experimental	Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	Biological: Quadrivalent VLP Vaccine
Placebo	Placebo Comparator	Participants received one IM injection of 0.5 mL of placebo on Day 0.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Quadrivalent VLP Vaccine	Biological	Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine	Quadrivalent VLP Vaccine

Measure	Description	Time Frame
Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains	Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.	Day 14 (post-vaccination) up to ~8 months

Measure	Description	Time Frame
Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain	Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following inclusion criteria to be eligible for participation in this study; no protocol waivers are allowed:

Participants must have a body mass index (BMI) below 40 kg/m^2;
Participants are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
Participants must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, and vital signs; Note: Participants with a pre-existing chronic disease will be allowed to participate if the disease is stable and, according to the Investigator's judgment, the condition is unlikely to confound the results of the study or pose additional risk to the participant by participating in the study. Stable disease is generally defined as no new onset or exacerbation of pre-existing chronic disease three months prior to vaccination. Based on the Investigator's judgment, a participant with more recent stabilization of a disease could also be eligible.
Female participants must have a negative urine pregnancy test result at the Screening/Vaccination visit (Visit 1).
Female participants of childbearing potential must use an effective method of contraception for one month prior to vaccination and agree to continue employing adequate birth control measures for at least 60 days post-vaccination. Moreover, female participants must have no plan to become pregnant for at least two months post-vaccination. Abstinent participants should be asked what method(s) they would use should their circumstances change, and participants without a well-defined plan should be excluded. The following relationship or methods of contraception are considered to be effective:
- Hormonal contraceptives (e.g. oral, injectable, topical [patch], or estrogenic vaginal ring);
- Intra-uterine device with or without hormonal release;
- Male partner using a condom plus spermicide or sterilized partner (at least one year prior to vaccination);
- Credible self-reported history of heterosexual vaginal intercourse abstinence until at least 60 days post-vaccination;
- Female partner;
Non-childbearing females are defined as:
- Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to vaccination); or
- Post-menopausal (absence of menses for 24 consecutive months and age consistent with natural cessation of ovulation).

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from participating in this study; no protocol waivers are allowed:

Any participant whose medical condition(s) is sufficiently severe that annual influenza vaccination would be routinely recommended in the jurisdiction of recruitment, as per the Investigator's judgement;
According to the Investigator's opinion, history of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. 'Uncontrolled' is defined as:
- Requiring a new medical or surgical treatment during the three months prior to study vaccine administration unless the criteria outlined in inclusion criterion no. 5 can be met (i.e. the Investigator can justify inclusion based upon the innocuous nature of medical/surgical events and/or treatments);
- Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5 and is appropriately justified by the Investigator.
Any medical or neuropsychiatric condition or any history of excessive alcohol use or drug abuse which, in the Investigator's opinion, would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting;
Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, and inflammatory bowel disease) or any confirmed or suspected immunosuppressive condition or immunodeficiency including known or suspected human immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of lymphoproliferative disease;
History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic, neurologic, hematologic (including anemia and hemoglobinopathy), or metabolic disorders (including diabetes mellitus);
Because this is a placebo-controlled study, any participants in close contact with individuals considered to be at high risk for developing influenza-related complications (individuals considered at high risk for complications include adults and children who have chronic pulmonary or cardiovascular [except isolated hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders [including diabetes mellitus]).
Administration or planned administration of any non-influenza vaccine within 30 days prior to randomization up to blood sampling on Day 21. Immunization on an emergency basis will be evaluated case-by-case by the Investigator;
Administration of any adjuvanted or investigational influenza vaccine within one year prior to randomization or planned administration prior to the completion of the study;
Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live attenuated trivalent/quadrivalent inactivated influenza vaccine or split trivalent/quadrivalent inactivated influenza vaccine administered by intranasal, intradermal, or intramuscular route) within six months prior to randomization and up to completion of the study;
Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to randomization or planned use during the study period. Participants may not participate in any other investigational or marketed drug study while participating in this study until after the study;
Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month of study vaccine administration; any other cytotoxic or immunosuppressant drug, or any immunoglobulin preparation within three months of vaccination and until the completion of the study. Low doses of nasal or inhaled glucocorticoids are allowed. Topical steroids are permitted;
Any significant disorder of coagulation including, but not limited to, treatment with warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet medications (e.g. low-dose aspirin [no more than 325 mg/day]), and without a clinically apparent bleeding tendency are eligible. Participants treated with new generation drugs that do not increase the risk of intramuscular bleeding (e.g. clopidogrel) are also eligible;
History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine or tobacco;
History of anaphylactic allergic reactions to plants or plants components;
Use of antihistamines with systemic absorption for more than 14 days in the four weeks prior to vaccination or use of antihistamines 48 hours prior to study vaccination (the use of topical antihistamines and nasal or inhaled steroids is acceptable);
Use of prophylactic medications (e.g. acetaminophen/paracetamol, aspirin, naproxen, or ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to vaccination. Any participant discovered to have taken a prophylactic medication to prevent or pre-empt symptoms due to vaccination within the 24 hours prior to planned randomization must be delayed until at least the 24 hours period is met;
Planned use of influenza antiviral treatment medication before the collection of nasopharyngeal swabs (e.g. oseltamivir, zanamivir, rapivab);
Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating;
Participants who have received a blood transfusion within 90 days prior to study vaccination;
Any female participant who has a positive or doubtful pregnancy test result prior to vaccination or who is lactating;
Participants with abnormal vital signs (systolic blood pressure [BP] > 140 mmHg and/or diastolic BP ≥ 90 mmHg, heart rate ≤ 45 beats/min and ≥ 100 beats/min) evaluated by an Investigator to be clinically significant. A participant with abnormal vital signs results may be included in the study based on Investigator's judgment (e.g. a resting hear rate ≤ 45 in highly trained athletes);
Presence of any febrile illness (including an oral temperature ≥ 38.0 ˚C within 24 hours prior to vaccination. Such participants may be re-evaluated for enrolment after resolution of illness;
Cancer or treatment for cancer within three years prior to study vaccine administration.

Persons with a history of cancer who are disease-free without treatment for three years or more are eligible. However, individuals with conditions such as treated and uncomplicated basal cell carcinoma of the skin or non-treated, non-disseminated local prostate cancer may be eligible;
Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study or any employee of Medicago;
Participants with a history of Guillain-Barré Syndrome.

Name	Affiliation	Role
Medical Director	Medicago	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site 222		Mobile	Alabama	36608	United States
Site 210

PubMed Identifier	Type	Citation	Retractions
33065035	Result	Ward BJ, Makarkov A, Seguin A, Pillet S, Trepanier S, Dhaliwall J, Libman MD, Vesikari T, Landry N. Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (>/=65 years): two multicentre, randomised phase 3 trials. Lancet. 2020 Nov 7;396(10261):1491-1503. doi: 10.1016/S0140-6736(20)32014-6. Epub 2020 Oct 13.

ID	Title	Description
FG000	Quadrivalent VLP Vaccine	Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
FG001	Placebo

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 13, 2017	May 25, 2023

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 Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains

Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.

The Per Protocol (PP) set consisted of the participants who participated in the study until at least the end of the peak period or for at least five months or until the end of the surveillance period.

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG0004814 OG0014812

Title

Denominators

Categories

Title	Measurements
	OG000110 OG001169

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Vaccine Efficacy	34.9			2-Sided	95	17.6	48.6			The VE success criterion is defined as a >40% lower limit of the two-sided 95% confidence interval (CI).		Other	Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants [ARV]/attack rate in unvaccinated participants [ARU]) x 100%.

Secondary

Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain

Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.

PP Set

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains

Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

PP Set

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain

Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

PP Set

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Occurrences of Protocol-Defined ILI Cases

Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.

PP Set

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One Immediate Complaint

Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.

SAS

Posted

Number

Participants

15 minutes post vaccination

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One Solicited Local and Systemic Reactions

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 7

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With ≥ Severe Solicited Local and Systemic Reactions

Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 7

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Secondary

Number of Participants With ≥ Severe Related Solicited Reactions

Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related."

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 7

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Secondary

Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Number of Participants With ≥ Severe Unsolicited TEAEs

The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Number of Participants With ≥ Severe Related Unsolicited Reactions

The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related." AE and TEAEs are defined in outcome measure #10.

SAS

Posted

Number

Participants

Day 0 (post-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts

Secondary

Number of Participants With an Occurrence of Death

The number of participants in each treatment group with an occurrence of death was assessed.

SAS

Posted

Number

Participants

Day 0 up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One Serious TEAE

A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.

SAS

Posted

Number

Participants

Day 0 up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One AE Leading to Withdrawal

An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.

SAS

Posted

Number

Participants

Day 0 up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)

All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.

SAS

Posted

Number

Participants

Day 0 up to ~8 months

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain

The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

Immunogenicity Per Protocol (IPP) Set consisted of a subset of participants who participated in the immunogenicity portion of the study, who had a Day 21 immunogenicity sample collection.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

IPP Set

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 0 (pre-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain

Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

IPP Set

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 0 (pre-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.

IPP Set

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain

The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

IPP Set

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain

Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

IPP Set

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 0 (pre-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants

Secondary

GMFR of MN Antibody Response for Each Homologous Strain

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.

IPP Set

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain

The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.

IPP Set

Posted

Geometric Mean

95% Confidence Interval

mm^2

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain

Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

IPP Set

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 0 (pre-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain

Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.

IPP Set

Posted

Number

95% Confidence Interval

Percentage of Participants

Day 0 (pre-vaccination) up to Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Secondary

GMFR of SRH Antibody Response for Each Homologous Strain

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.

IPP Set

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 0 (pre-vaccination), Day 21

ID	Title	Description
OG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
OG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Anorectal infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Appendicitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Bronchitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Cellulitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Diverticulitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Influenza	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Myelitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Otitis media acute	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pneumonia	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0013 events3 affected5,072 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pyelonephritis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Sepsis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Tonsillitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Tooth abscess	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Urinary tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gastrointestinal stromal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Anaphylactic reaction	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Completed suicide	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Drug abuse	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Suicide attempt	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Dizziness	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Headache	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypoaesthesia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Migraine	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Syncope	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Coronary artery disease	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Extrasystoles	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Aortic dissection	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Deep vein thrombosis	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Peripheral venous disease	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Colitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Volvulus	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events1 affected5,072 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
End stage renal disease	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Premature delivery	Pregnancy, puerperium and perinatal conditions	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Chest pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Chills	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Complication associated with device	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Non-cardiac chest pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pyrexia	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Blood potassium decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hepatic enzyme increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Snake bite	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abscess limb	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Abscess of eyelid	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Acarodermatitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Acute sinusitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Atypical pneumonia	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Bacterial infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Bacterial vaginosis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Bacterial vulvovaginitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Balanitis candida	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Bronchitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00013 events13 affected5,064 at risk EG00125 events25 affected5,072 at risk
Bullous impetigo	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Carbuncle	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Cellulitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0011 events1 affected5,072 at risk
Chronic sinusitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Clostridium difficile infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Conjunctivitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0017 events7 affected5,072 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Cystitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0006 events6 affected5,064 at risk EG0012 events2 affected5,072 at risk
Diarrhoea infectious	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Diverticulitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Ear infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0015 events4 affected5,072 at risk
Epididymitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Eye infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Fungal infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Fungal skin infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Furuncle	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Gastroenteritis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00010 events10 affected5,064 at risk EG00121 events20 affected5,072 at risk
Gastroenteritis viral	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0012 events2 affected5,072 at risk
Gastrointestinal infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gingivitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Gonorrhoea	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hepatitis infectious mononucleosis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Herpes simplex	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Herpes zoster	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Hordeolum	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Impetigo	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Infectious mononucleosis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Influenza	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG0015 events5 affected5,072 at risk
Kidney infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Labyrinthitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Laryngitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Localised infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0004 events3 affected5,064 at risk EG0014 events4 affected5,072 at risk
Mastitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Measles	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Nasopharyngitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00057 events56 affected5,064 at risk EG00157 events55 affected5,072 at risk
Oral herpes	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0007 events6 affected5,064 at risk EG0012 events2 affected5,072 at risk
Oral infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Osteomyelitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Otitis externa	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Otitis media	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0006 events6 affected5,064 at risk EG0013 events3 affected5,072 at risk
Paronychia	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pericoronitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Periodontitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Peritonitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pharyngitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00010 events10 affected5,064 at risk EG00112 events11 affected5,072 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00012 events11 affected5,064 at risk EG0017 events7 affected5,072 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Pilonidal cyst	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pneumonia	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG00112 events11 affected5,072 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Rash pustular	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Respiratory tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG0012 events2 affected5,072 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Rhinitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00038 events31 affected5,064 at risk EG00132 events27 affected5,072 at risk
Sinusitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00026 events24 affected5,064 at risk EG00118 events18 affected5,072 at risk
Skin candida	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Skin infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Staphylococcal infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Systemic viral infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Tonsillitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG0015 events5 affected5,072 at risk
Tooth abscess	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0017 events7 affected5,072 at risk
Tooth infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0013 events3 affected5,072 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG000139 events126 affected5,064 at risk EG001126 events117 affected5,072 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Urinary tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG00014 events12 affected5,064 at risk EG00112 events12 affected5,072 at risk
Urosepsis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Vaginal infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Viral infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Viral pharyngitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Viral sinusitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0015 events5 affected5,072 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Wound infection	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0015 events5 affected5,072 at risk
Allergy to animal	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Allergy to arthropod bite	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Drug hypersensitivity	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Food allergy	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypersensitivity	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0013 events3 affected5,072 at risk
Seasonal allergy	Immune system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Hyperthyroidism	Endocrine disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypogonadism	Endocrine disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypothyroidism	Endocrine disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0012 events2 affected5,072 at risk
Thyroid cyst	Endocrine disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Gout	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0013 events3 affected5,072 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Obesity	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0013 events3 affected5,072 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Affect lability	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Anxiety	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0017 events7 affected5,072 at risk
Attention deficit/hyperactivity disorder	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Bipolar disorder	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Depression	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0015 events5 affected5,072 at risk
Insomnia	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG0015 events5 affected5,072 at risk
Major depression	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Panic attack	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Sleep disorder	Psychiatric disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Amnesia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Aphonia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Burning sensation	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dizziness	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG00011 events11 affected5,064 at risk EG0019 events9 affected5,072 at risk
Facial paralysis	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Headache	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG000132 events113 affected5,064 at risk EG001127 events111 affected5,072 at risk
Hyperaesthesia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypoaesthesia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Loss of consciousness	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Migraine	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0005 events5 affected5,064 at risk EG0016 events6 affected5,072 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Paraesthesia	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Presyncope	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Retinal migraine	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Sciatica	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0014 events4 affected5,072 at risk
Sensory loss	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Syncope	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Tension headache	Nervous system disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cataract	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Corneal opacity	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dry eye	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Eye discharge	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Eye irritation	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Eye paraesthesia	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Eye pruritus	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Eye swelling	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Glaucoma	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Keratitis	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lacrimation increased	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0013 events3 affected5,072 at risk
Ocular hyperaemia	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Photokeratitis	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Retinal detachment	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Visual impairment	Eye disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Ear pain	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0018 events5 affected5,072 at risk
Excessive cerumen production	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
External ear inflammation	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Vertigo	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0014 events4 affected5,072 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0013 events3 affected5,072 at risk
Arrhythmia	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0013 events2 affected5,072 at risk
Atrial fibrillation	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cardiac failure	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cardiac flutter	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Palpitations	Cardiac disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Circulatory collapse	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Flushing	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Haematoma	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hot flush	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypertension	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG00018 events18 affected5,064 at risk EG00116 events16 affected5,072 at risk
Hypertensive crisis	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypotension	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Lymphoedema	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Peripheral coldness	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Peripheral venous disease	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Thrombophlebitis	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Vasculitis	Vascular disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Allergic sinusitis	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0014 events4 affected5,072 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0012 events2 affected5,072 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00039 events39 affected5,064 at risk EG00143 events41 affected5,072 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0008 events8 affected5,064 at risk EG0014 events4 affected5,072 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0016 events4 affected5,072 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00051 events49 affected5,064 at risk EG00129 events28 affected5,072 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Nasal pruritus	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00056 events54 affected5,064 at risk EG00161 events57 affected5,072 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pharyngeal ulceration	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00010 events9 affected5,064 at risk EG0017 events7 affected5,072 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00025 events24 affected5,064 at risk EG00128 events28 affected5,072 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00010 events10 affected5,064 at risk EG0015 events5 affected5,072 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00042 events40 affected5,064 at risk EG00140 events39 affected5,072 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0014 events4 affected5,072 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG00027 events26 affected5,064 at risk EG00118 events18 affected5,072 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Tonsillar disorder	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0014 events4 affected5,072 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG00010 events10 affected5,064 at risk EG0014 events4 affected5,072 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0012 events2 affected5,072 at risk
Acid peptic disease	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Coeliac disease	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Colitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Constipation	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Dental caries	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG00014 events14 affected5,064 at risk EG00122 events20 affected5,072 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0014 events4 affected5,072 at risk
Enteritis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Flatulence	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Food poisoning	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Gastritis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0015 events5 affected5,072 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Glossodynia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Haematochezia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Nausea	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG00021 events21 affected5,064 at risk EG00110 events10 affected5,072 at risk
Noninfective gingivitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Odynophagia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Paraesthesia oral	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Proctalgia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Stomatitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0013 events3 affected5,072 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Toothache	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0005 events5 affected5,064 at risk EG0014 events4 affected5,072 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Uvulitis	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Vomiting	Gastrointestinal disorders	MedDRA V20.1	Systematic Assessment	EG00013 events13 affected5,064 at risk EG0019 events9 affected5,072 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Cold urticaria	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0014 events4 affected5,072 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Guttate psoriasis	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events1 affected5,072 at risk
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0015 events5 affected5,072 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0006 events6 affected5,064 at risk EG0017 events6 affected5,072 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0014 events4 affected5,072 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0014 events4 affected5,072 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG00019 events17 affected5,064 at risk EG00117 events17 affected5,072 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG00023 events22 affected5,064 at risk EG00118 events18 affected5,072 at risk
Bursa disorder	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events1 affected5,072 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Muscle disorder	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0013 events3 affected5,072 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0013 events2 affected5,072 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0009 events9 affected5,064 at risk EG0013 events3 affected5,072 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0013 events3 affected5,072 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG00028 events28 affected5,064 at risk EG00128 events28 affected5,072 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0007 events7 affected5,064 at risk EG0013 events3 affected5,072 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0013 events3 affected5,072 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG00015 events13 affected5,064 at risk EG0016 events6 affected5,072 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dysuria	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Renal cyst	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Urinary retention	Renal and urinary disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Bartholin's cyst	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0014 events4 affected5,072 at risk
Genital rash	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Menopausal symptoms	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events1 affected5,072 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Nipple pain	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Asthenia	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Axillary pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Chest discomfort	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Chest pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0015 events5 affected5,072 at risk
Chills	General disorders	MedDRA V20.1	Systematic Assessment	EG00019 events19 affected5,064 at risk EG00113 events13 affected5,072 at risk
Cyst	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Discomfort	General disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Drug withdrawal syndrome	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Facial pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Fatigue	General disorders	MedDRA V20.1	Systematic Assessment	EG00032 events28 affected5,064 at risk EG00129 events29 affected5,072 at risk
Feeling hot	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Hangover	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Inflammation	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Influenza like illness	General disorders	MedDRA V20.1	Systematic Assessment	EG000102 events82 affected5,064 at risk EG001122 events87 affected5,072 at risk
Injection site bruising	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Injection site erythema	General disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0012 events2 affected5,072 at risk
Injection site haematoma	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Injection site hypersensitivity	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Injection site hypoaesthesia	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Injection site inflammation	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Injection site oedema	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Injection site pain	General disorders	MedDRA V20.1	Systematic Assessment	EG00029 events29 affected5,064 at risk EG0018 events8 affected5,072 at risk
Injection site pruritus	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Injection site reaction	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Injection site swelling	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Injection site warmth	General disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0010 events0 affected5,072 at risk
Injury associated with device	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Malaise	General disorders	MedDRA V20.1	Systematic Assessment	EG0005 events5 affected5,064 at risk EG0015 events5 affected5,072 at risk
Oedema peripheral	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pain	General disorders	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0013 events3 affected5,072 at risk
Peripheral swelling	General disorders	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Pyrexia	General disorders	MedDRA V20.1	Systematic Assessment	EG00011 events11 affected5,064 at risk EG00114 events13 affected5,072 at risk
Swelling	General disorders	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0017 events7 affected5,072 at risk
Vaccination site haematoma	General disorders	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Blood cholesterol increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Blood creatinine increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Blood iron decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Blood magnesium decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Blood oestrogen decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Blood pressure decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Blood pressure diastolic increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Blood pressure increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0005 events5 affected5,064 at risk EG0010 events0 affected5,072 at risk
Body temperature increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Cardiac murmur	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Electrocardiogram QT prolonged	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Glomerular filtration rate decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0002 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Influenza B virus test positive	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Progesterone decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Respiratory rate increased	Investigations	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Vitamin B12 decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Vitamin D decreased	Investigations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0014 events4 affected5,072 at risk
Animal scratch	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0012 events2 affected5,072 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Burns second degree	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0007 events5 affected5,064 at risk EG0013 events3 affected5,072 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Fall	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Foreign body in eye	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0003 events3 affected5,064 at risk EG0011 events1 affected5,072 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0004 events4 affected5,064 at risk EG0017 events7 affected5,072 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Mucosal excoriation	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0006 events5 affected5,064 at risk EG0015 events5 affected5,072 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0011 events1 affected5,072 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0005 events5 affected5,064 at risk EG00110 events10 affected5,072 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0012 events2 affected5,072 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Superficial injury of eye	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0010 events0 affected5,072 at risk
Wound	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0012 events2 affected5,072 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA V20.1	Systematic Assessment	EG0000 events0 affected5,064 at risk EG0011 events1 affected5,072 at risk
Sexual abuse	Social circumstances	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Viral tonsilitis	Infections and infestations	MedDRA V20.1	Systematic Assessment	EG0001 events1 affected5,064 at risk EG0010 events0 affected5,072 at risk
Pharyngeal paraesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA V20.1	Systematic Assessment	EG0002 events2 affected5,064 at risk EG0011 events1 affected5,072 at risk

ID	Term
D014777	Virus Diseases
D012327	RNA Virus Infections
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections
D007251	Influenza, Human
D009976	Orthomyxoviridae Infections
D007239	Infections

ID	Title	Description
BG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
BG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Quadrivalent VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine or placebo on Day 0.	1	5,064	55	5,064	930	5,064
EG001	Placebo	Participants received one IM injection of 0.5 mL of placebo on Day 0.	2	5,072	51	5,072	918	5,072