Efficacy of a Plant-derived Quadrivalent Virus-like Parti... | NCT03739112

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
Fluarix Quadrivalent® Comparator Vaccine	Active Comparator	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.	Biological: Fluarix Quadrivalent® Comparator Vaccine

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Occurrences of Protocol-Defined Influenza-Like Illness (ILI) Due to Any Laboratory-Confirmed Influenza Strains	Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was 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. The number of laboratory-confirmed ILI cases caused by any influenza strains are reported.	Day 14 (post-vaccination) up to ~9 months

Secondary Outcomes

Measure	Description	Time Frame
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 were matched (and/or antigenically similar) to the strains covered in the vaccine formulation was measured by sequential RT-PCR & serotyping. The vaccine-matched strains included: homologous A/Michigan/45/2015 [H1N1], homologous A/Singapore/INFIMH-16-0019/2016 [H3N2], homologous B/Colorado/06/2017 and homologous B/Phuket/3073/2013) covered in the vaccine formulation. A participant was 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. The number of laboratory-confirmed ILI cases caused by vaccine-matched influenza strains (all matched strains) are reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; participants must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
Participants must have a body mass index (BMI) ≤35 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;
Male and female participants must be 65 years of age and older at the Screening/Vaccination visit (Visit 1);
Participants must be non-institutionalized (e.g. not living in rehabilitation centres or old-age homes; living in an elderly community is acceptable) and have no acute or evolving medical problems prior to study participation and 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 are 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.

Exclusion Criteria:

According to the Investigator's opinion, history of an ongoing acute or evolving medical or neuropsychiatric illness. 'Evolving' was 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 that would render the participant unable to provide informed consent or unable to provide valid safety observations and reporting, including methadone (methadone as treatment for opioid dependence may be acceptable if the participant has been otherwise opioid-free for at least three years);
Any autoimmune disease other than hypothyroidism on stable replacement therapy (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, type 1 diabetes, 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;
Any history of status asthmaticus or ongoing serious problems with asthma, hospitalization for asthma control, or recurrent asthma episodes requiring medical attention in the last three years (one or more episodes per year);
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 was 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 IM 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 ten 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 100 mg/day]), and without a clinically apparent bleeding tendency are eligible. Participants treated with new generation drugs that do not increase the risk of IM bleeding (e.g. clopidogrel) are also eligible;
History of allergy to any of the constituents of the Quadrivalent VLP Influenza Vaccine, any components of the active comparator quadrivalent vaccine, or tobacco;
History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts);
Use of antihistamines within 48 hours prior to study vaccination;
Daily use of large doses of medication for pain control or inflammation (e.g. opioids, nonsteroidal anti-inflammatory drugs [NSAIDs]). Use of a singular regular dose either in the morning or at bedtime would not be exclusionary;
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;
Planned use of influenza antiviral treatment medication before the collection of nasopharyngeal (NP) 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;
Participants with abnormal vital signs (systolic blood pressure [BP] ≥ 150 mmHg and/or diastolic BP ≥ 95 mmHg for individuals taking antihypertensive medication and ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg for individuals not taking antihypertensive medication; heart rate [HR] ≤ 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 HR ≤ 45 in highly trained athletes);
Presence of any febrile illness (including an oral temperature [OT] ≥ 38.0 ˚C within 24 hours prior to vaccination;
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) of the Investigator or any employee of Medicago (or their family members);
Participants with a history of Guillain-Barré Syndrome.

Name	Affiliation	Role
Medical Director	Medicago	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
(Site 225) Coastal Clinical Research		Mobile	Alabama	36608	United States
(Site 201) Clinical Research Consortium

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 (30 μg) 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	Active Comparator (Fluarix)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 24, 2018	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 Influenza-Like Illness (ILI) Due to Any Laboratory-Confirmed Influenza Strains

Occurrences of laboratory-confirmed ILI caused by any influenza viral strains was measured by reverse transcriptase polymerase chain reaction (RT-PCR). A participant was 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. The number of laboratory-confirmed ILI cases caused by any influenza 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 ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG0005996 OG0016026

Title

Denominators

Categories

Title	Measurements
	OG000118 OG001130

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						percent VE	8.8			2-Sided	95	-16.7	28.7			VE of VLP vaccine versus Fluarix = (1-ARVv/ARVc) x 100% where ARVv = attack rate in participants vaccinated with the Quadrivalent VLP Influenza vaccine and ARVc = attack rate in participants vaccinated with an active Fluarix.		Non-Inferiority	Non-inferiority was concluded if the lower limit of the two-sided 95% confidence interval (CI) for relative vaccine efficacy (VE) was > -20%.

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 were matched (and/or antigenically similar) to the strains covered in the vaccine formulation was measured by sequential RT-PCR & serotyping. The vaccine-matched strains included: homologous A/Michigan/45/2015 [H1N1], homologous A/Singapore/INFIMH-16-0019/2016 [H3N2], homologous B/Colorado/06/2017 and homologous B/Phuket/3073/2013) covered in the vaccine formulation. A participant was 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. The number of laboratory-confirmed ILI cases caused by vaccine-matched influenza strains (all matched strains) are reported.

PP set.

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Secondary

Number of Occurrences of Protocol-Defined Respiratory Illness Due to Any Laboratory-Confirmed Influenza Strains

Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) was measured by sequential RT-PCR. 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. The number of protocol-defined respiratory illness cases caused by any laboratory-confirmed influenza strain (matched, mismatched, and un-typed) are reported.

PP set.

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

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

Occurrences of protocol-defined respiratory illness vaccine caused by vaccine-matched influenza strains was measured by sequential RT-PCR & serotyping. The vaccine-matched strains included: homologous A/Michigan/45/2015 [H1N1], homologous A/Singapore/INFIMH-16-0019/2016 [H3N2], homologous B/Colorado/06/2017 and homologous B/Phuket/3073/2013. 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. The number of protocol-defined respiratory illness cases caused by one or more vaccine-matched strains are reported.

PP set.

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Secondary

Number of Occurrences of Protocol-Defined ILI

Occurrences of protocol-defined ILI that were confirmed or not by laboratory testing were assessed. A participant was 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. The number of protocol-defined ILI cases (confirmed or not) are reported.

PP set.

Posted

Number

Number of cases

Day 14 (post-vaccination) up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

Number of Participants With at Least One Immediate Complaints

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. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

15 minutes post vaccination

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

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

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 7

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

Number of Participants With ≥ Severe Solicited Local and Systemic Reaction

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 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. ≥ Severe events included severe and potentially life-threatening events. Any ≥severe solicited reactions are reported.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 7

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Secondary

Number of Participants With ≥ Severe Related Solicited Reactions

Participants were monitored for both solicited local reactions (erythema, swelling, & pain at the injection site) & solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in axilla, & swelling in neck). The intensity of 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 FDA Guidance for Industry. ≥ Severe events included severe and potentially life-threatening events. Any ≥severe related (possibly related, probably related, and definitely related to the study treatments [as defined by investigator]) solicited events are reported.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 7

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine 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 pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

Number of Participants With ≥ Severe Unsolicited TEAEs

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and pain). AE: any untoward medical occurrence in a participant or clinical investigation participant who received study drug, with or without a causal relationship with the treatment. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination. 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 FDA Guidance for Industry. ≥ severe events included severe and potentially life-threatening events. Any ≥ severe unsolicited reactions are reported.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)

Secondary

Number of Participants With ≥ Severe Related Unsolicited Reactions

Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, & pain). AE: any untoward medical occurrence in a participant who received study drug, with or without a causal relationship with treatment. An AE was considered treatment-emergent if it began on or after date & time of Study Day 0 vaccination. Intensity of solicited reactions was graded as mild (1) easily tolerated & not interfere with usual activity; moderate (2) interferes with daily activity, but participant still able to function; severe (3) incapacitating & participant unable to work/complete usual activity/ potentially life threatening; (4) likely to be life-threatening if not treated in a timely manner, according to FDA Guidance for Industry. ≥ severe events included severe & potentially life-threatening events. Any ≥severe related (possibly, probably, & definitely related to study treatments [as defined by investigator]) unsolicited events are reported.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 (post-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)

Secondary

Number of Participants With at Least One Serious Adverse Event (SAE)

An AE was any untoward medical occurrence in a participant who received study drug, with or without a causal relationship with treatment. An SAE was an AE that resulted in death, was life threatening, resulted in a persistent or significant disability or incapacity, resulted in or prolonged an existing hospitalization, was a congenital anomaly or birth defect, or was another important medical event.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

Number of Occurrences of Death

The number of participants who died during the study was assessed.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Withdrew Due to an AE

An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who received study drug, 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.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

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 reported. Plausibility should be interpreted broadly however; the only clear exceptions were 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. NOCDs were collected from vaccination on Day 0 to the end of the surveillance period.

SAS. Participants that were non-compliant to protocol/GCP, as per investigator, were excluded from analysis.

Posted

Count of Participants

Participants

Day 0 up to ~9 months

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

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

GMTs were measured using a HI assay for the homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

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

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

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

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: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

IPP set.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (pre-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts

Secondary

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

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 homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

IPP set.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts

Secondary

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

GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0), was measured using an HI assay homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013, and the heterologous strains: H1N1 = A/Brisbane/59/2007; H3N2 = A/Uruguay/716/2007; B/Malaysia = B/Malaysia/2506/2004; B/Florida = B/Florida/4/2006.

IPP set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants

Secondary

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

GMTs were measured using an MN assay for homologous strains:H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Secondary

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

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: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (pre-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine 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 using an MN assay for H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Secondary

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

GMA was measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Geometric Mean

95% Confidence Interval

mm^2

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Secondary

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

The percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 (pre-vaccination) to Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Secondary

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

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: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Number

95% Confidence Interval

percentage of participants

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine 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 using an SRH assay for homologous strains: H1N1 = A/Michigan/45/2015; H3N2 = A/Singapore/INFIMH-16-0019/2016; B/Colorado = B/Colorado/06/2017; B/Phuket = B/Phuket/3073/2013.

IPP set.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Baseline (Day 0), Day 21

ID	Title	Description
OG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Appendicitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0014 events4 affected6,366 at risk
Bursitis infective	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Empyema	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Endocarditis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
H1N1 influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Necrotising fasciitis staphylococcal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Orchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Osteomyelitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00020 events20 affected6,352 at risk EG00112 events11 affected6,366 at risk
Pneumonia legionella	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pneumonia viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pyelonephritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Sepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sialoadenitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urosepsis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acral lentiginous melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Biliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0015 events5 affected6,366 at risk
Bronchial neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Female reproductive neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Intraductal papillary mucinous neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lung squamous cell carcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lymphoplasmacytoid lymphoma/immunocytoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Malignant melanoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0016 events6 affected6,366 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Thyroid cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Triple negative breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Waldenstrom's macroglobulinaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Splenic haematoma	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Chronic idiopathic pain syndrome	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Completed suicide	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Delirium	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Disorientation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Mental status changes	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Mood disorder due to a general medical condition	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cerebellar stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected6,352 at risk EG0019 events9 affected6,366 at risk
Chronic inflammatory demyelinating polyradiculoneuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dementia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hydrocephalus	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
IVth nerve paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Parkinson's disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Parkinsonism	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Seizure	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0015 events5 affected6,366 at risk
Transient global amnesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected6,352 at risk EG0013 events3 affected6,366 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Amaurosis fugax	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Corneal degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dacryostenosis acquired	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Deafness	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected6,352 at risk EG0018 events8 affected6,366 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Angina unstable	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00012 events11 affected6,352 at risk EG00113 events12 affected6,366 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cardiac failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0015 events3 affected6,366 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0006 events5 affected6,352 at risk EG0013 events3 affected6,366 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0013 events3 affected6,366 at risk
Pericardial effusion	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pericarditis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sinus arrest	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Accelerated hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Angiodysplasia	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Aortic aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Aortic dissection	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Circulatory collapse	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Extremity necrosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events1 affected6,366 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0007 events5 affected6,352 at risk EG0016 events6 affected6,366 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0016 events6 affected6,366 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected6,352 at risk EG0012 events1 affected6,366 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Mesenteric arterial occlusion	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Reactive gastropathy	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Subileus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Cholestasis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Camptocormia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lateral patellar compression syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected6,352 at risk EG0019 events9 affected6,366 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events1 affected6,366 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Systemic scleroderma	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Haematuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Renal colic	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Renal failure	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Uterovaginal prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Varicocele	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hamartoma	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Syringomyelia	Congenital, familial and genetic disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Death	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Incarcerated hernia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Non-cardiac chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Surgical failure	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vascular stent stenosis	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Fibrin D dimer increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Animal attack	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0014 events4 affected6,366 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events2 affected6,366 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Fascial rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0012 events2 affected6,366 at risk
Foreign body aspiration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0012 events2 affected6,366 at risk
Lacrimal structure injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events1 affected6,366 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Atrial appendage closure	Surgical and medical procedures	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Device dislocation	Product Issues	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Adenovirus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Borrelia infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Bronchitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected6,352 at risk EG0018 events8 affected6,366 at risk
Cellulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Cystitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0016 events6 affected6,366 at risk
Cystitis escherichia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Diverticulitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ear infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Erysipelas	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Eye infection bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Folliculitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gastroenteritis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected6,352 at risk EG0018 events8 affected6,366 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Genital infection fungal	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gingivitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Haemorrhagic fever with renal syndrome	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Helicobacter infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatitis C	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Herpes simplex	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Herpes zoster	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0015 events5 affected6,366 at risk
Hordeolum	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Infected bite	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Influenza	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG00114 events13 affected6,366 at risk
Laryngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Localised infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nasal herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nasopharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00088 events88 affected6,352 at risk EG00177 events76 affected6,366 at risk
Onychomycosis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Oral herpes	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0013 events3 affected6,366 at risk
Otitis media	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Periodontitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pertussis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pharyngitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pilonidal cyst	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pneumonia	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0014 events4 affected6,366 at risk
Respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG0015 events5 affected6,366 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Rhinitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected6,352 at risk EG0016 events6 affected6,366 at risk
Root canal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sinusitis	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00013 events13 affected6,352 at risk EG0019 events9 affected6,366 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Streptococcal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tinea infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tooth abscess	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tooth infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00053 events52 affected6,352 at risk EG00148 events47 affected6,366 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected6,352 at risk EG00113 events13 affected6,366 at risk
Vaginal infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Varicella zoster virus infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Viral infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Wound infection	Infections and infestations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Eye naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0005 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0012 events2 affected6,366 at risk
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lymph node pain	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Seasonal allergy	Immune system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Goitre	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0012 events2 affected6,366 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gout	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0015 events5 affected6,366 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG0015 events5 affected6,366 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0012 events2 affected6,366 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events1 affected6,366 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lactose intolerance	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lipid metabolism disorder	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0018 events8 affected6,366 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Abnormal dreams	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Aggression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Anxiety	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0011 events1 affected6,366 at risk
Confusional state	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Depression	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Fear	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Initial insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Insomnia	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0012 events2 affected6,366 at risk
Listless	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nervousness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Restlessness	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events1 affected6,366 at risk
Sleep disorder	Psychiatric disorders	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Complex regional pain syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dementia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dizziness	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00020 events19 affected6,352 at risk EG00125 events24 affected6,366 at risk
Dysgeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Facial paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Head discomfort	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG00073 events61 affected6,352 at risk EG00171 events66 affected6,366 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypogeusia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Memory impairment	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Migraine	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Movement disorder	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events2 affected6,366 at risk
Paraesthesia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Parkinson's disease	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Polyneuropathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Posterior cortical atrophy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Presyncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Radiculopathy	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Restless legs syndrome	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Sciatica	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Sinus headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Somnolence	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Syncope	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tension headache	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Visual field defect	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events1 affected6,366 at risk
White matter lesion	Nervous system disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Astigmatism	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Binocular eye movement disorder	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Blepharitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Blepharochalasis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Blindness transient	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cataract	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chalazion	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Corneal warpage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dry age-related macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dry eye	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye discharge	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye inflammation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye irritation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Eye pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye pruritus	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Eye swelling	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Eyelid irritation	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eyelid margin crusting	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eyelid oedema	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eyelid pain	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Glaucoma	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hyalosis asteroid	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Keratitis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lacrimation increased	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Macular fibrosis	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Neovascular age-related macular degeneration	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ocular hyperaemia	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ocular rosacea	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vision blurred	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Visual impairment	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected6,352 at risk EG0017 events7 affected6,366 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Angina pectoris	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Arrhythmia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected6,352 at risk EG00111 events11 affected6,366 at risk
Atrial flutter	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Bradycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bundle branch block bilateral	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cardiac dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cardiomegaly	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0015 events5 affected6,366 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dilatation atrial	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Extrasystoles	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Left atrial dilatation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0015 events5 affected6,366 at risk
Mitral valve calcification	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Palpitations	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Right atrial dilatation	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tachycardia	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0015 events5 affected6,366 at risk
Aneurysm	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Aortic dilatation	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Aortic disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Aortic stenosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Flushing	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0014 events3 affected6,366 at risk
Haematoma	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Hot flush	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypertension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG00035 events35 affected6,352 at risk EG00127 events27 affected6,366 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypotension	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Microangiopathy	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Peripheral coldness	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Thrombosis	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Varicose vein	Vascular disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Allergic cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG0015 events5 affected6,366 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00042 events42 affected6,352 at risk EG00147 events46 affected6,366 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0017 events7 affected6,366 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0012 events2 affected6,366 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00031 events29 affected6,352 at risk EG00132 events30 affected6,366 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00047 events47 affected6,352 at risk EG00142 events41 affected6,366 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pharyngeal paraesthesia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00010 events10 affected6,352 at risk EG00122 events21 affected6,366 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00016 events16 affected6,352 at risk EG00117 events17 affected6,366 at risk
Respiratory symptom	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0010 events0 affected6,366 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00042 events41 affected6,352 at risk EG00156 events56 affected6,366 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sinus pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG00033 events31 affected6,352 at risk EG00127 events25 affected6,366 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tonsillar cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG0017 events7 affected6,366 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG00110 events8 affected6,366 at risk
Anal incontinence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0016 events6 affected6,366 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00053 events50 affected6,352 at risk EG00156 events53 affected6,366 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Enlarged uvula	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Faeces soft	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0015 events5 affected6,366 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lip erythema	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events1 affected6,366 at risk
Lip pruritus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events1 affected6,366 at risk
Lip swelling	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Malocclusion	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00027 events27 affected6,352 at risk EG00132 events30 affected6,366 at risk
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Oesophageal motility disorder	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Oral pruritus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Palatal oedema	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tongue blistering	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tooth loss	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Toothache	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG0016 events6 affected6,366 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.0	Systematic Assessment	EG00013 events13 affected6,352 at risk EG00114 events13 affected6,366 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Steatohepatitis	Hepatobiliary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Blood blister	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0013 events3 affected6,366 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0015 events5 affected6,366 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nail bed disorder	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00010 events9 affected6,352 at risk EG0019 events8 affected6,366 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events3 affected6,366 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected6,352 at risk EG0018 events8 affected6,366 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00025 events25 affected6,352 at risk EG00130 events30 affected6,366 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0011 events1 affected6,366 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00021 events20 affected6,352 at risk EG00127 events26 affected6,366 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0013 events3 affected6,366 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected6,352 at risk EG0013 events3 affected6,366 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected6,352 at risk EG00112 events12 affected6,366 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0015 events5 affected6,366 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00034 events32 affected6,352 at risk EG00135 events35 affected6,366 at risk
Myosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Neck mass	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00011 events10 affected6,352 at risk EG00110 events10 affected6,366 at risk
Nuchal rigidity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0007 events7 affected6,352 at risk EG00112 events12 affected6,366 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0006 events6 affected6,352 at risk EG0014 events4 affected6,366 at risk
Osteosclerosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG00014 events14 affected6,352 at risk EG00111 events11 affected6,366 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0011 events1 affected6,366 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0011 events1 affected6,366 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Bladder discomfort	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Dysuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Hypertensive nephropathy	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Micturition urgency	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Renal cyst	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Renal disorder	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0017 events7 affected6,366 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Asthenia	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0010 events0 affected6,366 at risk
Axillary pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Chest discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Chest pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0015 events5 affected6,366 at risk
Chills	General disorders	MedDRA 21.0	Systematic Assessment	EG00015 events15 affected6,352 at risk EG00115 events15 affected6,366 at risk
Discomfort	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0012 events2 affected6,366 at risk
Face oedema	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Facial pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Fatigue	General disorders	MedDRA 21.0	Systematic Assessment	EG00027 events26 affected6,352 at risk EG00135 events32 affected6,366 at risk
Feeling hot	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Gait disturbance	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
General physical health deterioration	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hypothermia	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Induration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Inflammation	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Influenza like illness	General disorders	MedDRA 21.0	Systematic Assessment	EG0008 events8 affected6,352 at risk EG00111 events11 affected6,366 at risk
Injected limb mobility decreased	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Injection site bruising	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0014 events4 affected6,366 at risk
Injection site erythema	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events3 affected6,366 at risk
Injection site haematoma	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Injection site induration	General disorders	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Injection site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG00012 events12 affected6,352 at risk EG0017 events7 affected6,366 at risk
Injection site pruritus	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Injection site reaction	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Injection site swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0015 events5 affected6,366 at risk
Injection site warmth	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0012 events2 affected6,366 at risk
Malaise	General disorders	MedDRA 21.0	Systematic Assessment	EG00011 events11 affected6,352 at risk EG0016 events6 affected6,366 at risk
Mass	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Oedema peripheral	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0013 events3 affected6,366 at risk
Pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0004 events4 affected6,352 at risk EG0012 events2 affected6,366 at risk
Peripheral swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Pyrexia	General disorders	MedDRA 21.0	Systematic Assessment	EG0009 events9 affected6,352 at risk EG00116 events15 affected6,366 at risk
Swelling	General disorders	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0016 events6 affected6,366 at risk
Tenderness	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vaccination site haematoma	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vaccination site hypoaesthesia	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Vaccination site induration	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vaccination site pain	General disorders	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Vaccination site pruritus	General disorders	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Blood cholesterol increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Blood pressure increased	Investigations	MedDRA 21.0	Systematic Assessment	EG00013 events13 affected6,352 at risk EG0019 events9 affected6,366 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Body temperature increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0012 events2 affected6,366 at risk
Cardiac imaging procedure abnormal	Investigations	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Thyroid hormones decreased	Investigations	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0014 events4 affected6,366 at risk
Arthropod sting	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0013 events2 affected6,366 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0017 events7 affected6,366 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0014 events4 affected6,366 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0010 events0 affected6,366 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Muscle contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0002 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0005 events5 affected6,352 at risk EG0013 events3 affected6,366 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events3 affected6,352 at risk EG0016 events5 affected6,366 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0013 events3 affected6,366 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0012 events2 affected6,366 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0003 events2 affected6,352 at risk EG0010 events0 affected6,366 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0011 events1 affected6,366 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0000 events0 affected6,352 at risk EG0011 events1 affected6,366 at risk
Bone contusion	Injury, poisoning and procedural complications	MedDRA 21.0	Systematic Assessment	EG0001 events1 affected6,352 at risk EG0010 events0 affected6,366 at risk

ID	Term
D014777	Virus Diseases
D012327	RNA Virus Infections
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections

ID	Title	Description
BG000	Quadrivalent (30 μg) 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	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine 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 (30 μg) VLP Vaccine	Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.	12	6,352	263	6,352	935	6,352
EG001	Active Comparator (Fluarix)	Participants received one IM injection of 0.5 mL of 15 μg/strain of the Fluarix Quadrivalent® comparator vaccine on Day 0.	17	6,366	266	6,366	908	6,366