Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and... | NCT00865566

ID	Type	Description	Link
10753	Registry Identifier	DAIDS ES

Name	Class
HIV Vaccine Trials Network	NETWORK

Label	Type	Description	Intervention Names
1	Experimental	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.	Biological: DNA plasmid vaccine Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccine
2	Placebo Comparator	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.	Biological: DNA vaccine placebo Biological: HIV-1 recombinant adenovirus vaccine placebo

Name	Type	Description	Arm Group Labels	Other Names
DNA plasmid vaccine	Biological	4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid	1

Measure	Description	Time Frame
Participant Dropout Through Month 48	For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.	Enrollment through Month 48 visit
Participant Dropout Prior to Unblinding	The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.	Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)
Participant Dropout After Unblinding	The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time. For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.	April 23, 2013 through trial closure (up to Month 48 visit)
HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit	For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 and -2 negative
Good general health
Fully circumcised
Experienced one or both of the following HIV risk criteria in the 6 months before study entry:
1. Unprotected anal intercourse with one or more male or MTF transgender partner(s)
2. Anal intercourse with two or more male or MTF transgender partners
Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)
Ad5 neutralizing antibody (nAb) titer less than 1:18
Have access to a participating study site and are willing to be followed during the study
Demonstrate understanding of the study
Willing to receive HIV test results
Willing to discuss HIV infection risks and amenable to risk-reduction counseling
Agrees not to enroll in another study of an investigational research agent before unblinding of this study
NOTE: MTF transgender volunteers who have undergone gender reassignment surgery (GRS) are eligible to participate if they provide documentation from a health care provider confirming that they were fully circumcised prior to GRS. MTF transgender volunteers who have not undergone GRS are eligible to participate if they meet all enrollment criteria. Receipt of hormonal therapy does not make a transgender volunteer ineligible.

Exclusion Criteria:

HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination
Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed
Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.
Blood products within 90 days prior to first study vaccination
Immunoglobulin within 90 days prior to first study vaccination
Live attenuated vaccines other than influenza vaccine within 30 days prior to first study vaccination
Investigational research agents within 90 days prior to first study vaccination
Influenza vaccine or any vaccines that are not live attenuated within 14 days prior to first study vaccination
Allergy treatment with antigen injections within 30 days prior to first study vaccination or that are scheduled within 14 days after first vaccination
Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history that, in the judgment of the investigator, has significant implications for current health
Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.
Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log
History of serious adverse reactions to vaccinations, including anaphylaxis or allergy to any of the vaccine's components
Current anti-tuberculosis prophylaxis or therapy
Autoimmune disease. People with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event assessments are not excluded.
Immunodeficiency
Bleeding disorder
History of malignancy
Seizure disorder. People with a history of seizures who have had no seizures within the 3 years prior to study entry are not excluded.
Asthma other than mild, well-controlled asthma
Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic angioedema

Name	Affiliation	Role
Scott Hammer	Columbia University	Study Chair
Magdalena Sobieszczyk	Columbia University	Study Chair
Michael Yin	Columbia University	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama CRS		Birmingham	Alabama	35294	United States
The AIDS Research Alliance of America CRS

PubMed Identifier	Type	Citation	Retractions
18443427	Background	Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. doi: 10.4161/hv.4.6.6179. Epub 2008 Nov 28.
19031031	Background	Patterson S, Papagatsias T, Benlahrech A. Use of adenovirus in vaccines for HIV. Handb Exp Pharmacol. 2009;(188):275-93. doi: 10.1007/978-3-540-71029-5_13.

ID	Title	Description
FG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 21, 2014	Oct 8, 2018

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

Participant Dropout Through Month 48

For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.

MITT population

Posted

Count of Participants

Participants

Enrollment through Month 48 visit

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Units	Counts
Participants	OG0001251 OG0011245

Title

Denominators

Categories

Title	Measurements
	OG000340 OG001436

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	Cox proportional hazards model to assess the association between treatment assignment and dropout	Regression, Cox		<0.001		Hazard Ratio (HR)	0.73			2-Sided	95	0.63	0.84			HR is vaccine / placebo		Other	Score test

Primary

Participant Dropout Prior to Unblinding

The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.

MITT population

Posted

Count of Participants

Participants

Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

Participant Dropout After Unblinding

The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.

MITT population participants who were HIV-uninfected and on-study as of April 23, 2013

Posted

Count of Participants

Participants

April 23, 2013 through trial closure (up to Month 48 visit)

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit

For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.

Modified Intent-to-Treat Cohort

Posted

Number

participants

Enrollment through Month 48 visit

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit

For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.

Modified Intent-to-Treat Cohort

Posted

Number

participants

Enrollment through Month 24 visit

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness

For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.

All Enrolled Participants

Posted

Count of Participants

Participants

Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration

All enrolled participants

Posted

Count of Participants

Participants

Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Primary

Number of Participants Experiencing Systemic Reactogenicity

For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.

All enrolled participants

Posted

Count of Participants

Participants

Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination

ID	Title	Description
OG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
OG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any event in SOC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Anaemias NEC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0016 affected1,251 at risk
Ischaemic coronary artery disorders	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Coronary artery disorders NEC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Heart failures NEC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Supraventricular arrhythmias	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Ventricular arrhythmias and cardiac arrest	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Congenital, familial and genetic disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Haemoglobinopathies congenital	Congenital, familial and genetic disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG00115 affected1,251 at risk
Colitis (excl infective)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0013 affected1,251 at risk
Acute and chronic pancreatitis	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Duodenal ulcers and perforation	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Intestinal ulcers and perforation NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Abdominal hernias NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastric ulcers and perforation	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastrointestinal atonic and hypomotility disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastrointestinal disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastrointestinal stenosis and obstruction NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Non-site specific gastrointestinal haemorrhages	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Oesophageal ulcers and perforation	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Rectal inflammations NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0015 affected1,251 at risk
Pain and discomfort NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0013 affected1,251 at risk
Death and sudden death	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Withdrawal and rebound effects	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Acute and chronic sarcoidosis	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Allergies to foods, food additives, drugs and other chemicals	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00025 affected1,253 at risk EG00126 affected1,251 at risk
Abdominal and gastrointestinal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG00111 affected1,251 at risk
Bacterial infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0014 affected1,251 at risk
Infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Lower respiratory tract and lung infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0011 affected1,251 at risk
Upper respiratory tract infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Clostridia infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Sepsis, bacteraemia, viraemia and fungaemia NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Skin structures and soft tissue infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Staphylococcal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Streptococcal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Bone and joint infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Borrelial infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Breast infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Herpes viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Infectious disorders carrier	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Urinary tract infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Viral infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00015 affected1,253 at risk EG00115 affected1,251 at risk
Limb fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0012 affected1,251 at risk
Skull fractures, facial bone fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Non-site specific injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0012 affected1,251 at risk
Overdoses NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Poisoning and toxicity	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Site specific injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Skin injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Spinal fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Abdominal injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Cardiac and vascular procedural complications	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Cardiovascular injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Cerebral injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Muscle, tendon and ligament injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Pathways and sources of exposure	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Thermal burns	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Liver function analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Metabolism tests NEC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Potassium imbalance	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0013 affected1,251 at risk
Bursal disorders	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Intervertebral disc disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Muscle weakness conditions	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Myopathies	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0013 affected1,251 at risk
Prostatic neoplasms malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Colorectal neoplasms malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Gastric neoplasms malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Leukaemias acute lymphocytic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Testicular neoplasms malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Thyroid neoplasms malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0012 affected1,251 at risk
Seizures and seizure disorders NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0010 affected1,251 at risk
Central nervous system haemorrhages and cerebrovascular accidents	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Encephalopathies NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Mononeuropathies	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Neurological signs and symptoms NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Optic nerve disorders NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Transient cerebrovascular events	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Product Issues	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Device malfunction events NEC	Product Issues	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG00023 affected1,253 at risk EG00122 affected1,251 at risk
Suicidal and self-injurious behaviour	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG00013 affected1,253 at risk EG00111 affected1,251 at risk
Depressive disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0013 affected1,251 at risk
Substance related and addictive disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0012 affected1,251 at risk
Bipolar disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0013 affected1,251 at risk
Anxiety symptoms	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Psychotic disorder NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Confusion and disorientation	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mental disorders NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Schizoaffective and schizophreniform disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Schizophrenia NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Somatic symptom disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Renal failure and impairment	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Renal lithiasis	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Testicular and epididymal disorders NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0012 affected1,251 at risk
Pulmonary thrombotic and embolic conditions	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Pneumothorax and pleural effusions NEC	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Skin and subcutaneous tissue ulcerations	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0011 affected1,251 at risk
Peripheral embolism and thrombosis	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Non-site specific necrosis and vascular insufficiency NEC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Vascular hypertensive disorders NEC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Vascular hypotensive disorders	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Any event in SOC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG00022 affected1,253 at risk EG00117 affected1,251 at risk
Lymphatic system disorders NEC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG00020 affected1,253 at risk EG00115 affected1,251 at risk
Anaemias NEC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Leukocytoses NEC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Red blood cell abnormal findings NEC	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Spleen disorders	Blood and lymphatic system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0015 affected1,251 at risk
Supraventricular arrhythmias	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Cardiac signs and symptoms NEC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Rate and rhythm disorders NEC	Cardiac disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Congenital, familial and genetic disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Male reproductive tract disorders congenital	Congenital, familial and genetic disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG0017 affected1,251 at risk
Ear disorders NEC	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0015 affected1,251 at risk
Inner ear signs and symptoms	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0011 affected1,251 at risk
External ear disorders NEC	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Middle ear disorders NEC	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Eustachian tube disorders	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Hearing losses	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Tympanic membrane disorders (excl infections)	Ear and labyrinth disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Endocrine disorders	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG0012 affected1,251 at risk
Thyroid hypofunction disorders	Endocrine disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0012 affected1,251 at risk
Endocrine abnormalities of gonadal function NEC	Endocrine disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Male gonadal function disorders	Endocrine disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Thyroid hyperfunction disorders	Endocrine disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG00017 affected1,253 at risk EG00111 affected1,251 at risk
Lid, lash and lacrimal infections, irritations and inflammations	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0011 affected1,251 at risk
Ocular disorders NEC	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0012 affected1,251 at risk
Conjunctival and corneal bleeding and vascular disorders	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Ocular sensation disorders	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0013 affected1,251 at risk
Visual disorders NEC	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0010 affected1,251 at risk
Conjunctival infections, irritations and inflammations	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Eyelid movement disorders	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Lacrimation disorders	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Ocular infections, inflammations and associated manifestations	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Blindness (excl colour blindness)	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Glaucomas (excl congenital)	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Refractive and accommodative disorders	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Retinal, choroid and vitreous infections and inflammations	Eye disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG000149 affected1,253 at risk EG001146 affected1,251 at risk
Diarrhoea (excl infective)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00053 affected1,253 at risk EG00153 affected1,251 at risk
Nausea and vomiting symptoms	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00028 affected1,253 at risk EG00121 affected1,251 at risk
Gastrointestinal and abdominal pains (excl oral and throat)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00022 affected1,253 at risk EG00113 affected1,251 at risk
Stomatitis and ulceration	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00011 affected1,253 at risk EG0016 affected1,251 at risk
Gastrointestinal atonic and hypomotility disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0019 affected1,251 at risk
Haemorrhoids and gastrointestinal varices (excl oesophageal)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0019 affected1,251 at risk
Anal and rectal disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0018 affected1,251 at risk
Gastrointestinal signs and symptoms NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0016 affected1,251 at risk
Gastrointestinal disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0014 affected1,251 at risk
Dental pain and sensation disorders	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0014 affected1,251 at risk
Dyspeptic signs and symptoms	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0016 affected1,251 at risk
Intestinal haemorrhages	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0015 affected1,251 at risk
Gastritis (excl infective)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Colitis (excl infective)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0014 affected1,251 at risk
Non-site specific gastrointestinal haemorrhages	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0012 affected1,251 at risk
Abdominal hernias NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Anal and rectal signs and symptoms	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Dental and periodontal infections and inflammations	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Diaphragmatic hernias	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Flatulence, bloating and distension	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Gingival disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Gingival haemorrhages	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Oesophageal ulcers and perforation	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Tongue disorders	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0010 affected1,251 at risk
Tongue signs and symptoms	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Benign neoplasms gastrointestinal (excl oral cavity)	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Gastrointestinal inflammatory disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Oral dryness and saliva altered	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Abdominal findings abnormal	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Anal and rectal pains	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Dental disorders NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Faecal abnormalities NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastrointestinal dyskinetic disorders	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Gastrointestinal fistulae	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Inguinal hernias	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Oral soft tissue pain and paraesthesia	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Peptic ulcers and perforation	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Rectal inflammations NEC	Gastrointestinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG000138 affected1,253 at risk EG001104 affected1,251 at risk
Injection site reactions	General disorders	MedDRA 20.1	Non-systematic Assessment	EG00065 affected1,253 at risk EG00133 affected1,251 at risk
Asthenic conditions	General disorders	MedDRA 20.1	Non-systematic Assessment	EG00041 affected1,253 at risk EG00127 affected1,251 at risk
Febrile disorders	General disorders	MedDRA 20.1	Non-systematic Assessment	EG00017 affected1,253 at risk EG00115 affected1,251 at risk
Feelings and sensations NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG0019 affected1,251 at risk
General signs and symptoms NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG00110 affected1,251 at risk
Pain and discomfort NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0015 affected1,251 at risk
Administration site reactions NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0016 affected1,251 at risk
Oedema NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0015 affected1,251 at risk
Therapeutic and nontherapeutic responses	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0014 affected1,251 at risk
Vaccination site reactions	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0011 affected1,251 at risk
Mass conditions NEC	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0013 affected1,251 at risk
Withdrawal and rebound effects	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Inflammations	General disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Hepatobiliary disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Hepatocellular damage and hepatitis NEC	Hepatobiliary disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Cholecystitis and cholelithiasis	Hepatobiliary disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Cholestasis and jaundice	Hepatobiliary disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Hepatobiliary signs and symptoms	Hepatobiliary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG00025 affected1,253 at risk EG00114 affected1,251 at risk
Atopic disorders	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG0017 affected1,251 at risk
Allergies to foods, food additives, drugs and other chemicals	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0009 affected1,253 at risk EG0015 affected1,251 at risk
Allergic conditions NEC	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0011 affected1,251 at risk
Anaphylactic and anaphylactoid responses	Immune system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG000531 affected1,253 at risk EG001549 affected1,251 at risk
Upper respiratory tract infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG000275 affected1,253 at risk EG001254 affected1,251 at risk
Neisseria infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00079 affected1,253 at risk EG00183 affected1,251 at risk
Viral infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00075 affected1,253 at risk EG00172 affected1,251 at risk
Chlamydial infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00072 affected1,253 at risk EG00172 affected1,251 at risk
Treponema infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00032 affected1,253 at risk EG00141 affected1,251 at risk
Abdominal and gastrointestinal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00037 affected1,253 at risk EG00129 affected1,251 at risk
Herpes viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00031 affected1,253 at risk EG00130 affected1,251 at risk
Streptococcal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00022 affected1,253 at risk EG00131 affected1,251 at risk
Urinary tract infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00020 affected1,253 at risk EG00124 affected1,251 at risk
Lower respiratory tract and lung infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00016 affected1,253 at risk EG00114 affected1,251 at risk
Papilloma viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00012 affected1,253 at risk EG00117 affected1,251 at risk
Bacterial infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00015 affected1,253 at risk EG00111 affected1,251 at risk
Eye and eyelid infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0009 affected1,253 at risk EG00117 affected1,251 at risk
Skin structures and soft tissue infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00011 affected1,253 at risk EG00114 affected1,251 at risk
Dental and oral soft tissue infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0009 affected1,253 at risk EG00114 affected1,251 at risk
Ectoparasitic infestations	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG00115 affected1,251 at risk
Ear infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG00110 affected1,251 at risk
Staphylococcal infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG0015 affected1,251 at risk
Tinea infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0018 affected1,251 at risk
Influenza viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0015 affected1,251 at risk
Infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0014 affected1,251 at risk
Male reproductive tract infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0015 affected1,251 at risk
Fungal infections NEC	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0011 affected1,251 at risk
Hepatitis viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0014 affected1,251 at risk
Candida infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Molluscum contagiosum viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Epstein-Barr viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Giardia infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Tuberculous infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Amoebic infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Bone and joint infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Caliciviral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Clostridia infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Coxsackie viral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Cytomegaloviral infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Escherichia infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Haemophilus infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Helicobacter infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Nematode infections	Infections and infestations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG000108 affected1,253 at risk EG001101 affected1,251 at risk
Skin injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00028 affected1,253 at risk EG00120 affected1,251 at risk
Muscle, tendon and ligament injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00024 affected1,253 at risk EG00123 affected1,251 at risk
Non-site specific injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00013 affected1,253 at risk EG0019 affected1,251 at risk
Non-site specific procedural complications	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00012 affected1,253 at risk EG0018 affected1,251 at risk
Limb fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0009 affected1,253 at risk EG00110 affected1,251 at risk
Site specific injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG0018 affected1,251 at risk
Neurological and psychiatric procedural complications	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG0013 affected1,251 at risk
Bone and joint injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0015 affected1,251 at risk
Thermal burns	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0017 affected1,251 at risk
Exposures to agents or circumstances NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0012 affected1,251 at risk
Radiation injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Cerebral injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0012 affected1,251 at risk
Fractures and dislocations NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0014 affected1,251 at risk
Eye injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Skull fractures, facial bone fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0013 affected1,251 at risk
Thoracic cage fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Chest and lung injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Gastrointestinal and hepatobiliary procedural complications	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Ear injuries NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Overdoses NEC	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Poisoning and toxicity	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Reproductive system and breast injuries	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Spinal fractures and dislocations	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Vaccination related complications	Injury, poisoning and procedural complications	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG00039 affected1,253 at risk EG00163 affected1,251 at risk
Vascular tests NEC (incl blood pressure)	Investigations	MedDRA 20.1	Non-systematic Assessment	EG00028 affected1,253 at risk EG00147 affected1,251 at risk
Reproductive hormone analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0017 affected1,251 at risk
Liver function analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Red blood cell analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0012 affected1,251 at risk
Carbohydrate tolerance analyses (incl diabetes)	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Digestive enzymes	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Mineral and electrolyte analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Platelet analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Bacteria identification and serology (excl mycobacteria)	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Cardiac auscultatory investigations	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Coagulation and bleeding analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Heart rate and pulse investigations	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Investigations NEC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Musculoskeletal and soft tissue tests NEC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mycobacteria identification and serology	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Tissue enzyme analyses NEC	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
White blood cell analyses	Investigations	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG00027 affected1,253 at risk EG00120 affected1,251 at risk
Diabetes mellitus (incl subtypes)	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0013 affected1,251 at risk
Fat soluble vitamin deficiencies and disorders	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0015 affected1,251 at risk
Appetite disorders	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0011 affected1,251 at risk
Elevated cholesterol	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Disorders of purine metabolism	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0010 affected1,251 at risk
General nutritional disorders NEC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Potassium imbalance	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Fluid intake increased	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Food malabsorption and intolerance syndromes (excl sugar intolerance)	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Lipid metabolism and deposit disorders NEC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Water soluble vitamin deficiencies	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Elevated triglycerides	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Hyperlipidaemias NEC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Hypoglycaemic conditions NEC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Magnesium metabolism disorders	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Protein metabolism disorders NEC	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Sugar intolerance (excl glucose intolerance)	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Total fluid volume decreased	Metabolism and nutrition disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00097 affected1,253 at risk EG001107 affected1,251 at risk
Musculoskeletal and connective tissue pain and discomfort	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00047 affected1,253 at risk EG00149 affected1,251 at risk
Muscle pains	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00025 affected1,253 at risk EG00124 affected1,251 at risk
Joint related signs and symptoms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00017 affected1,253 at risk EG00119 affected1,251 at risk
Muscle related signs and symptoms NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0012 affected1,251 at risk
Tendon disorders	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Bone related signs and symptoms	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Arthropathies NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Bone disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Bursal disorders	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Intervertebral disc disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Muscle weakness conditions	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0013 affected1,251 at risk
Muscle tone abnormalities	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Cartilage disorders	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Extremity deformities	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Joint related disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Musculoskeletal and connective tissue infections and inflammations NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Osteoarthropathies	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Rheumatoid arthropathies	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Soft tissue disorders NEC	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Synovial disorders	Musculoskeletal and connective tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG00018 affected1,253 at risk EG00117 affected1,251 at risk
Skin neoplasms benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG00013 affected1,253 at risk EG00114 affected1,251 at risk
Lip and oral cavity neoplasms benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Skin neoplasms malignant and unspecified (excl melanoma)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Soft tissue neoplasms benign NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Nervous system neoplasms benign NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Reproductive neoplasms male benign NEC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG000103 affected1,253 at risk EG00188 affected1,251 at risk
Headaches NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG00039 affected1,253 at risk EG00141 affected1,251 at risk
Neurological signs and symptoms NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG00030 affected1,253 at risk EG00122 affected1,251 at risk
Paraesthesias and dysaesthesias	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG00010 affected1,253 at risk EG00111 affected1,251 at risk
Migraine headaches	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG0012 affected1,251 at risk
Sensory abnormalities NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG0011 affected1,251 at risk
Disturbances in consciousness NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0011 affected1,251 at risk
Mononeuropathies	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Peripheral neuropathies NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0011 affected1,251 at risk
Lumbar spinal cord and nerve root disorders	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Narcolepsy and hypersomnia	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Seizures and seizure disorders NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Cervical spinal cord and nerve root disorders	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Coordination and balance disturbances	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Disturbances in sleep phase rhythm	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Facial cranial nerve disorders	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Memory loss (excl dementia)	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mental impairment (excl dementia and memory loss)	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Neurologic visual problems NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Sleep disturbances NEC	Nervous system disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG00072 affected1,253 at risk EG00165 affected1,251 at risk
Depressive disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG00025 affected1,253 at risk EG00122 affected1,251 at risk
Anxiety symptoms	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG00020 affected1,253 at risk EG00117 affected1,251 at risk
Disturbances in initiating and maintaining sleep	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0008 affected1,253 at risk EG00112 affected1,251 at risk
Substance related and addictive disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0009 affected1,253 at risk EG0014 affected1,251 at risk
Attention deficit and disruptive behaviour disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0014 affected1,251 at risk
Anxiety disorders NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0011 affected1,251 at risk
Bipolar disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0013 affected1,251 at risk
Panic attacks and disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0012 affected1,251 at risk
Sexual desire disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0012 affected1,251 at risk
Stress disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Emotional and mood disturbances NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Schizophrenia NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Behaviour and socialisation disturbances	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Fear symptoms and phobic disorders (incl social phobia)	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Fluctuating mood symptoms	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mental disorders NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mood alterations with depressive symptoms	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Mood disorders NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Schizoaffective and schizophreniform disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Sleep disorders NEC	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Somatic symptom disorders	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Suicidal and self-injurious behaviour	Psychiatric disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG00019 affected1,253 at risk EG00123 affected1,251 at risk
Bladder and urethral symptoms	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG00011 affected1,253 at risk EG00112 affected1,251 at risk
Renal lithiasis	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0004 affected1,253 at risk EG0016 affected1,251 at risk
Urethral disorders NEC	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0014 affected1,251 at risk
Urinary abnormalities	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Urinary tract signs and symptoms NEC	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Bladder neoplasms	Renal and urinary disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG00027 affected1,253 at risk EG00126 affected1,251 at risk
Penile disorders NEC (excl erection and ejaculation)	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG00012 affected1,253 at risk EG0017 affected1,251 at risk
Reproductive tract signs and symptoms NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0014 affected1,251 at risk
Erection and ejaculation conditions and disorders	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0015 affected1,251 at risk
Prostate and seminal vesicles infections and inflammations	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0014 affected1,251 at risk
Reproductive tract disorders NEC (excl neoplasms)	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0011 affected1,251 at risk
Testicular and epididymal disorders NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0011 affected1,251 at risk
Breast signs and symptoms	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Scrotal disorders NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0012 affected1,251 at risk
Breast disorders NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Pelvic prolapse conditions	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Sexual function and fertility disorders NEC	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Spermatogenesis and semen disorders	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Testicular and epididymal neoplasms	Reproductive system and breast disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG000123 affected1,253 at risk EG00195 affected1,251 at risk
Upper respiratory tract signs and symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00049 affected1,253 at risk EG00144 affected1,251 at risk
Coughing and associated symptoms	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00034 affected1,253 at risk EG00124 affected1,251 at risk
Nasal congestion and inflammations	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00022 affected1,253 at risk EG00117 affected1,251 at risk
Paranasal sinus disorders (excl infections and neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG00015 affected1,253 at risk EG00110 affected1,251 at risk
Bronchospasm and obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0016 affected1,251 at risk
Pharyngeal disorders (excl infections and neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0014 affected1,251 at risk
Breathing abnormalities	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0013 affected1,251 at risk
Nasal disorders NEC	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0014 affected1,251 at risk
Respiratory tract disorders NEC	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0011 affected1,251 at risk
Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Pulmonary oedemas	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Respiratory failures (excl neonatal)	Respiratory, thoracic and mediastinal disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Any event in SOC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG000112 affected1,253 at risk EG00186 affected1,251 at risk
Dermatitis and eczema	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00029 affected1,253 at risk EG00117 affected1,251 at risk
Rashes, eruptions and exanthems NEC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00021 affected1,253 at risk EG00125 affected1,251 at risk
Apocrine and eccrine gland disorders	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00017 affected1,253 at risk EG00111 affected1,251 at risk
Dermal and epidermal conditions NEC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00011 affected1,253 at risk EG00111 affected1,251 at risk
Pruritus NEC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG00014 affected1,253 at risk EG0018 affected1,251 at risk
Erythemas	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0007 affected1,253 at risk EG0012 affected1,251 at risk
Psoriatic conditions	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0006 affected1,253 at risk EG0013 affected1,251 at risk
Acnes	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0003 affected1,253 at risk EG0013 affected1,251 at risk
Angioedemas	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Bullous conditions	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0011 affected1,251 at risk
Papulosquamous conditions	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0012 affected1,251 at risk
Pilar disorders NEC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Purpura and related conditions	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Skin and subcutaneous tissue ulcerations	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Skin cysts and polyps	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0011 affected1,251 at risk
Skin preneoplastic conditions NEC	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0010 affected1,251 at risk
Alopecias	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Dermatitis ascribed to specific agent	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Hyperkeratoses	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Hyperpigmentation disorders	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Photosensitivity and photodermatosis conditions	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Rosaceas	Skin and subcutaneous tissue disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Social circumstances	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Crime victims	Social circumstances	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk
Any event in SOC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG00033 affected1,253 at risk EG00149 affected1,251 at risk
Vascular hypertensive disorders NEC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG00025 affected1,253 at risk EG00142 affected1,251 at risk
Peripheral vascular disorders NEC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0005 affected1,253 at risk EG0014 affected1,251 at risk
Haemorrhages NEC	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0002 affected1,253 at risk EG0012 affected1,251 at risk
Lymphoedemas	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0001 affected1,253 at risk EG0010 affected1,251 at risk
Peripheral embolism and thrombosis	Vascular disorders	MedDRA 20.1	Non-systematic Assessment	EG0000 affected1,253 at risk EG0011 affected1,251 at risk

ID	Term
D015658	HIV Infections
D000257	Adenoviridae Infections

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases
D004266	DNA Virus Infections

ID	Title	Description
BG000	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid
BG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid
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	Vaccine	Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid Recombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid	1	1,253	77	1,253	833	1,253
EG001	Placebo	Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped. DNA vaccine placebo: 1 mL IM via Biojector® in either deltoid HIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid	11	1,251	95	1,251	828	1,251