Protective Efficacy of Flublok® Quadrivalent Versus Licen... | NCT02285998

Label	Type	Description	Intervention Names
Flublok Quadrivalent Influenza Vaccine	Experimental	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL	Biological: Flublok Quadrivalent Influenza Vaccine
Inactivated Influenza Vaccine	Active Comparator	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.	Biological: Inactivated Influenza Vaccine

Name	Type	Description	Arm Group Labels	Other Names
Flublok Quadrivalent Influenza Vaccine	Biological	Intramuscular injection of vaccine	Flublok Quadrivalent Influenza Vaccine

Measure	Description	Time Frame
Number of Participants With rtPCR-confirmed Influenza-Like Illness	rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination	14 days post vaccination through and up to 32 weeks post vaccination

Measure	Description	Time Frame
Number of Participants With Culture-confirmed Influenza-Like Illness	Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines. Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms: Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Clinical Research		Mobile	Alabama	36608	United States
Clinical Research Consortium Arizona

PubMed Identifier	Type	Citation	Retractions
28636855	Derived	Dunkle LM, Izikson R, Patriarca P, Goldenthal KL, Muse D, Callahan J, Cox MMJ; PSC12 Study Team. Efficacy of Recombinant Influenza Vaccine in Adults 50 Years of Age or Older. N Engl J Med. 2017 Jun 22;376(25):2427-2436. doi: 10.1056/NEJMoa1608862.

ID	Title	Description
FG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With rtPCR-confirmed Influenza-Like Illness

rtPCR-confirmed, protocol-defined Influenza-Like Illness (ILI) caused by any influenza strain that begins at least 14 days post-vaccination

The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.

Posted

Number

participants

14 days post vaccination through and up to 32 weeks post vaccination

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts
Participants	OG0004303 OG0014301

Title

Denominators

Categories

Title	Measurements
	OG00096 OG001138

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	The primary efficacy analysis was based on the numbers of protocol-defined influenza-like illnesses with rtPCR-positive nasopharyngeal swabs detecting influenza virus of any strain. The Relative Vaccine Efficacy was 30% (10, 47). Non-inferiority would be concluded if the lower bound of the 95% CI for rVE was > -20%. Superiority of RIV4 in a pre-specified exploratory analysis required that the lower bound of the two-sided 95% CI of rVE be > +9%.					Relative Vaccine Efficacy (rVE)	30			2-Sided	95	10	47					Non-Inferiority or Equivalence	The sample size required to achieve 80% power was calculated based on a one-sided alpha level of 0.025 and an attack rate of 2% in the IIV4 and 1.53% for the Flublok groups respectively.

Secondary

Number of Participants With Culture-confirmed Influenza-Like Illness

Culture-confirmed protocol-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those strains represented in the study vaccines.

Protocol-defined ILI is defined as at least one of the following respiratory symptoms accompanied by at least one of the following systemic symptoms:

Respiratory symptoms: sore throat, cough, sputm production, wheezing, difficulty breathing Systemic symptoms: fever, chills (shivering), tiredness (fatigue), headache, myalgia (muscle ache)

The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.

Posted

Number

participants

14 days post vaccination through and up to 32 weeks post vaccination

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Secondary

Number of Participants With Culture-confirmed CDC-defined Influenza-Like Illness

Culture-confirmed CDC-defined Influenza-Like Illness (ILI) that begins at least 14 days post-vaccination caused by an influenza strain (identified from the same clinical sample) antigenically matched to those in the study vaccines.

CDC-defined ILI is defined as body temperature ≥100°F accompanied by cough and/or sore throat.

The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.

Posted

Number

participants

14 days post vaccination through and up to 32 weeks post vaccination

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Secondary

Number of Participants With rtPCR-confirmed CDC-defined Influenza-Like Illness

rtPCR-confirmed CDC-defined ILI that begins at least 14 days post-vaccination caused by any influenza strain.

The efficacy population includes all randomized subjects who received study vaccine and provided any follow-up for ILI beginning at least 14 days following vaccine administration.

Posted

Number

participants

14 days post vaccination through and up to 32 weeks post vaccination

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts

Secondary

Percentage of Participants With Seroconversion

Seroconversion rates (SCR) for all four antigens in a preselected subset of subjects.

The immunogenicity population includes all randomized subjects at the specific study sites pre-selected for serology who received study vaccine and provided serum samples on Days 0 and 28 for serologic testing.

Posted

Number

95% Confidence Interval

percentage of participants

Days 0 through 28

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts

Secondary

Number of Participants With Local Injection Site Reactogenicity

Solicited events of injection site reactogenicity reported during Day 0-7.

Solicited local reactogenicity events include subjects who recorded any injection site reaction data.

Posted

Number

participants

Days 0 through 7

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts
Participants

Secondary

Number of Participants With Unsolicited Adverse Events

Unsolicited adverse events reported in the 28 days following vaccine administration.

The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.

Posted

Number

participants

Days 0 through 28

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts
Participants

Secondary

Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)

Serious adverse events (SAEs) and medically-attended adverse events (MAEs) occurring during the period of follow-up through the influenza season (at least 6 months post-vaccination).

A MAE is an event that prompts an unplanned visit to a medical professional for diagnosis and/or treatment.

The safety population includes all randomized and vaccinated subjects who provided any safety data (solicited or unsolicited) following administration of study vaccine.

Posted

Number

participants

Day 0 through and up to 32 weeks post vaccination

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Secondary

Measure of Post-vaccination HAI GMTs

GMT titers for all four antigens in a preselected subset of subjects.

Posted

Geometric Mean

95% Confidence Interval

titer

Days 0 through 28

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts
Participants

Secondary

Number of Participants With Systemic Reactogenicity

Solicited events of systemic reactogenicity reported during Day 0-7.

Solicited systemic reactogenicity events include subjects who recorded any systemic reaction data.

Posted

Number

participants

Days 0 through 7

ID	Title	Description
OG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
OG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0006 affected4,328 at risk EG0016 affected4,344 at risk
Bronchitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0013 affected4,344 at risk
Diverticulitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0012 affected4,344 at risk
Influenza	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0013 affected4,344 at risk
Urinary tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0012 affected4,344 at risk
Cellulitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0013 affected4,344 at risk
Appendicitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Lung Infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Osteomyelitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Pyelonephritis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Abscess intestinal	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Device related infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Erysipelas	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Eye abscess	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Gangrene	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Osteomyelitis acute	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Otitis media	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Salmonellosis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Urinary tract infection fungal	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Urosepsis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0006 affected4,328 at risk EG0013 affected4,344 at risk
Myocardial infarction	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected4,328 at risk EG0013 affected4,344 at risk
Angina pectoris	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0012 affected4,344 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0012 affected4,344 at risk
Angina unstable	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0011 affected4,344 at risk
Coronary artery disease	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0011 affected4,344 at risk
Cardiac arrest	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Cardiac failure	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0012 affected4,344 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Arrhythmia	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Atrial flutter	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0008 affected4,328 at risk EG0017 affected4,344 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0014 affected4,344 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Tenosynovitis stenosans	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected4,328 at risk EG0016 affected4,344 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected4,328 at risk EG0012 affected4,344 at risk
Syncope	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0013 affected4,344 at risk
Convulsion	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Embolic stroke	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Encephalopathy	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Lacunar infarction	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Loss of consciousness	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Myelomalacia	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Sinus headache	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Thalamic infarction	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected4,328 at risk EG0011 affected4,344 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0011 affected4,344 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0012 affected4,344 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Ileus	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Volvulus	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0014 affected4,344 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0012 affected4,344 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0012 affected4,344 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0012 affected4,344 at risk
Abdominal wall neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Colorectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Rhabdomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Chest pain	General disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected4,328 at risk EG0016 affected4,344 at risk
Death	General disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0011 affected4,344 at risk
Non-cardiac chest pain	General disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected4,328 at risk EG0010 affected4,344 at risk
Asthenia	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Drug withdrawal syndrome	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hernia obstructive	General disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Oedema peripheral	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Pain	General disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected4,328 at risk EG0015 affected4,344 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected4,328 at risk EG0011 affected4,344 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0012 affected4,344 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0011 affected4,344 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Gout	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hypertensive crisis	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Aortic aneurysm	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Aortic dissection	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Arteriosclerosis	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Circulatory collapse	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Haemorrhage	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hypotension	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Thrombosis	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Abdominal hernia repair	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Alcohol detoxification	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Drug detoxification	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Gastric bypass	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hernia repair	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Intestinal resection	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Joint surgery	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected4,328 at risk EG0011 affected4,344 at risk
Urinary retention	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected4,328 at risk EG0010 affected4,344 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Renal necrosis	Renal and urinary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0011 affected4,344 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Hepatic haemorrhage	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Uterine disorder	Reproductive system and breast disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Haematocrit decreased	Investigations	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
International normalised ratio increased	Investigations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Troponin increased	Investigations	MedDRA (17.0)	Systematic Assessment	EG0001 affected4,328 at risk EG0010 affected4,344 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0012 affected4,344 at risk
Anxiety	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected4,328 at risk EG0011 affected4,344 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description
BG000	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine
BG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine
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	Flublok Quadrivalent Influenza Vaccine	Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine			145	4,328	1,122	4,328
EG001	Inactivated Influenza Vaccine	Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Inactivated Influenza Vaccine: Intramuscular injection of vaccine			132	4,344	1,206	4,344

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG000226 affected4,328 at risk EG001253 affected4,344 at risk
Influenza like illness	General disorders	MedDRA (17.0)	Systematic Assessment	EG000186 affected4,328 at risk EG001199 affected4,344 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG000178 affected4,328 at risk EG001177 affected4,344 at risk
Headache	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG000143 affected4,328 at risk EG001145 affected4,344 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG000129 affected4,328 at risk EG001156 affected4,344 at risk
Fatigue	General disorders	MedDRA (17.0)	Systematic Assessment	EG000106 affected4,328 at risk EG001100 affected4,344 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG00095 affected4,328 at risk EG00179 affected4,344 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG00059 affected4,328 at risk EG00197 affected4,344 at risk