Strategic Timing of Antiretroviral Treatment | NCT00867048

ID	Type	Description	Link
U01AI068641	U.S. NIH Grant/Contract		View source
2008-006439-12	EudraCT Number

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
Copenhagen HIV Programme	OTHER_GOV
Medical Research Council	OTHER_GOV
Kirby Institute

Label	Type	Description	Intervention Names
Early ART	Experimental	Initiate ART immediately following randomization	Drug: All licensed antiretroviral medications
Deferred ART	Active Comparator	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops	Drug: All licensed antiretroviral medications

Name	Type	Description	Arm Group Labels	Other Names
All licensed antiretroviral medications	Drug	In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Measure	Description	Time Frame
Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality		full follow-up, 9.3 years

Measure	Description	Time Frame
AIDs or AIDs Related Death	participant count	full follow-up, 9.3 years
Specific Non-AIDS Diagnoses		full follow-up, 9.3 years

Name	Affiliation	Role
James D Neaton, PhD	University of Minnesota	Principal Investigator
Abdel Babiker, PhD	Medical Research Council Clinical Trials Unit, London	Study Chair
Jens Lundgren, MD, DMSc	Copenhagen HIV Programme	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Alhambra	California	91803	United States
VA Greater Los Angeles Healthcare System

PubMed Identifier	Type	Citation	Retractions
22547421	Background	Babiker AG, Emery S, Fatkenheuer G, Gordin FM, Grund B, Lundgren JD, Neaton JD, Pett SL, Phillips A, Touloumi G, Vjechaj MJ; INSIGHT START Study Group. Considerations in the rationale, design and methods of the Strategic Timing of AntiRetroviral Treatment (START) study. Clin Trials. 2013;10(1 Suppl):S5-S36. doi: 10.1177/1740774512440342. Epub 2012 Apr 30.
26192873	Result	INSIGHT START Study Group; Lundgren JD, Babiker AG, Gordin F, Emery S, Grund B, Sharma S, Avihingsanon A, Cooper DA, Fatkenheuer G, Llibre JM, Molina JM, Munderi P, Schechter M, Wood R, Klingman KL, Collins S, Lane HC, Phillips AN, Neaton JD. Initiation of Antiretroviral Therapy in Early Asymptomatic HIV Infection. N Engl J Med. 2015 Aug 27;373(9):795-807. doi: 10.1056/NEJMoa1506816. Epub 2015 Jul 20.

Label	URL
INSIGHT network website, including information on the START trial	View source

ID	Title	Description
FG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Aug 28, 2017

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

Composite Endpoint of AIDS, Serious Non-AIDS Diagnoses, and All-cause Mortality

Posted

Count of Participants

Participants

full follow-up, 9.3 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Units	Counts
Participants	OG0002325 OG0012359

Title

Denominators

Categories

Title	Measurements
	OG000133 OG001215

Secondary

AIDs or AIDs Related Death

participant count

Posted

Count of Participants

Participants

full follow-up, 9.3 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Units	Counts
Participants	OG000

Secondary

Specific Non-AIDS Diagnoses

Posted

Count of Participants

Participants

full follow-up, 9.3 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Units	Counts
Participants	OG000

Secondary

Death, All-cause Mortality

Count of participants

Posted

Count of Participants

Participants

full follow-up, 9.3 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.

Units	Counts
Participants	OG000

Secondary

Quality of Life- Mean Change From Baseline in a Visual Analog Scale (VAS) for Perceived Current Health

Mean change from baseline of the VAS. This was a single data item where participants self-reported their perceived current state of health on a scale of 0-100 (0=worst possible and 100=best possible).

Posted

Mean

Standard Deviation

units on a scale

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Transmission Risk Behavior Outcome 1

Proportion of participants identifying as men who have sex with men (MSM) engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Change in Neurocognitive Function (in a Subset of Participants)

Mean change from baseline of the QNPZ-8 score. In the Neurology substudy of START, participants were administered a neuropsychological test battery of 8 tests (grooved peg board, finger tapping, Color Trails 1 and 2, Semantic Verbal Fluency, WAIS III Digit Symbol, HVLT-R Learning, HVLT-R Delayed Recall). Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Test scores were standardized to z-scores using baseline values as reference such that baseline values had a mean of 0 and standard deviation of 1. Z-scores > 0 indicate improvement over baseline levels. The quantitative neuropsychological performance z-score (QNPZ-8) was the mean of the z-scores across the the 8 tests. Analyses were by intention-to-treat principles.

Posted

Mean

95% Confidence Interval

units on a scale

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Large Artery Elasticity (in a Subset of Participants)

Mean change from baseline in large arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

Posted

Mean

Full Range

mL/mmHg x 10

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Rate of Lung Function Decline (in a Subset of Participants) Among

Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

Posted

Mean

95% Confidence Interval

mL/yr

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Changes in Bone Mineral Density (in a Subset of Participants) Measure 1

Mean percent change from baseline in bone mineral density at the spine. In the bone mineral density (BMD) substudy of START, participants underwent dual-enery x-ray absorptionmetry (DXA) to measure BMD at the spine and hip at baseline and annually. Analyses were by intention-to-treat principles.

Posted

Mean

95% Confidence Interval

percent

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Transmission Risk Behavior Outcome 2

Percentage of participants identifying as hetrosexual engaging in condomless sex with HIV serodifferent partners (CLS-D) at study month 12. Participant completed a self-reported questionnaire on transmission risk behavior during the "past two months" at the month 12 visit following randomization.

Posted

Count of Participants

Participants

12 month visit

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Small Artery Elasticity (in a Subset of Participants)

Mean change from baseline in small arterial elasticity. In the Arterial Elasticity substudy of START, participants had non-invasive measurements of radial artery blood pressure waveforms recorded at baseline, study months 4, 8, and 12, and then annually. Small arterial elasticity (SAE) and large arterial elasticity (LAE) were derived from analysis of the diastolic pulse waveform. Analyses were by intention-to-treat principles.

Posted

Mean

Full Range

mL/mmHg x 10

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Rate of Lung Function Decline (in a Subset of Participants) Among Non-smokers

Rate of lung function decline (slope of forced expiratory volume (FEV1)) over follow-up among self-reported non-smokers at study entry. In the pulmonary substudy of START, participants had post-bronchodilator spirometry measures collected at baseline and annually. Analyses were by intention-to-treat principles.

Posted

Mean

95% Confidence Interval

mL/yr

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Secondary

Changes in Bone Mineral Density (in a Subset of Participants) Measure 2

Posted

Mean

95% Confidence Interval

percent

4.5 years

ID	Title	Description
OG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.
OG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms. ART dosage and frequency were based on clinical decision in accordance with local/national prescribing guidelines.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0006 events5 affected2,325 at risk EG0017 events7 affected2,359 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events1 affected2,359 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected2,325 at risk EG0016 events6 affected2,359 at risk
Angina pectoris	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Angina unstable	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Arrhythmia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Atrial flutter	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cardiac failure	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0006 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Coronary artery disease	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Foetal arrhythmia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected2,325 at risk EG0012 events2 affected2,359 at risk
Palpitations	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Subvalvular aortic stenosis	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Alagille syndrome	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Anencephaly	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Congenital hydrocephalus	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Congenital hydronephrosis	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Microcephaly	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Ventricular septal defect	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Disorder of orbit	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Opsoclonus myoclonus	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Retinal artery occlusion	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Vision blurred	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0014 events2 affected2,359 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abdominal strangulated hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Colitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0011 events1 affected2,359 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0010 events0 affected2,359 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0014 events4 affected2,359 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Enteritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Gastritis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0013 events3 affected2,359 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Gastrointestinal toxicity	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Ileus	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected2,325 at risk EG0010 events0 affected2,359 at risk
Intra-abdominal fluid collection	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Megacolon	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Obstruction gastric	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Oesophageal achalasia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0016 events4 affected2,359 at risk
Proctitis	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0015 events5 affected2,359 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Vomiting	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0015 events4 affected2,359 at risk
Chills	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Complication of device insertion	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Death	General disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG00112 events12 affected2,359 at risk
Drowning	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Drug withdrawal syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Fatigue	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gait disturbance	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Impaired self-care	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Influenza like illness	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Necrobiosis	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Non-cardiac chest pain	General disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Peripheral swelling	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pyrexia	General disorders	MedDRA 25.0	Systematic Assessment	EG0008 events8 affected2,325 at risk EG00112 events11 affected2,359 at risk
Strangulated hernia	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0014 events4 affected2,359 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0016 events5 affected2,359 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Cholelithiasis migration	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0014 events3 affected2,359 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected2,325 at risk EG0012 events2 affected2,359 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Anaphylactic shock	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Hypersensitivity	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Sarcoidosis	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abdominal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abdominal infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abscess limb	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0007 events7 affected2,325 at risk EG0014 events4 affected2,359 at risk
Abscess neck	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Acute hepatitis B	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Acute hepatitis C	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0012 events2 affected2,359 at risk
Anal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 events5 affected2,325 at risk EG00114 events13 affected2,359 at risk
Appendicitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG00024 events24 affected2,325 at risk EG00117 events17 affected2,359 at risk
Appendicitis perforated	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Arteriovenous graft site abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Arthritis bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Bronchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0012 events2 affected2,359 at risk
Bronchitis viral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Burn infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Campylobacter sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Catheter site infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cellulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected2,325 at risk EG00112 events10 affected2,359 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Complicated appendicitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cryptosporidiosis infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dengue fever	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dengue haemorrhagic fever	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Device related infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Diabetic foot infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Diverticulitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0014 events3 affected2,359 at risk
Diverticulitis intestinal haemorrhagic	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dysentery	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Embolic pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Endocarditis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Epididymitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0011 events1 affected2,359 at risk
Epiglottic abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Erysipelas	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0014 events4 affected2,359 at risk
Escherichia pyelonephritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Extradural abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Febrile infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Fournier's gangrene	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Furuncle	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastroenteritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG00110 events10 affected2,359 at risk
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastrointestinal infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Genital herpes simplex	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Giardiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gonorrhoea	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Groin abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
HIV associated nephropathy	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
HIV peripheral neuropathy	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Hepatitis A	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0006 events6 affected2,325 at risk EG0014 events4 affected2,359 at risk
Hepatitis C	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Herpes simplex necrotising retinopathy	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Herpes zoster	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0013 events3 affected2,359 at risk
Infected skin ulcer	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Influenza	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0017 events7 affected2,359 at risk
Intervertebral discitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Large intestine infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Liver abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Localised infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Lymph node abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Lymphogranuloma venereum	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Malaria	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG00110 events9 affected2,359 at risk
Meningitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Meningitis streptococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Meningitis viral	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Mononucleosis syndrome	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Mycobacterium abscessus infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Necrotising fasciitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Neurosyphilis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0017 events6 affected2,359 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Orchitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0014 events4 affected2,359 at risk
Osteomyelitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Otitis media acute	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Paronychia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Parotid abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Parotitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0016 events4 affected2,359 at risk
Perirectal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Peritonitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pertussis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pilonidal disease	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pneumococcal bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pneumonia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Postoperative wound infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Proctitis chlamydial	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pyelonephritis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0012 events2 affected2,359 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pyomyositis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Rectal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Renal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Rubella	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Scrotal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Secondary syphilis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0016 events6 affected2,359 at risk
Sepsis syndrome	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Septic shock	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0013 events3 affected2,359 at risk
Shigella infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Soft tissue infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Strongyloidiasis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Syphilis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0014 events4 affected2,359 at risk
Tertiary syphilis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tonsillitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0013 events3 affected2,359 at risk
Tonsillitis streptococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tooth abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tuberculosis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Typhoid fever	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Urinary tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0007 events5 affected2,325 at risk EG0013 events3 affected2,359 at risk
Urosepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Varicella	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Viral infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Viral pharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Wound infection	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Wound sepsis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0004 events3 affected2,325 at risk EG0014 events4 affected2,359 at risk
Accidental poisoning	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0015 events4 affected2,359 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Carbon monoxide poisoning	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Fracture of penis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0013 events3 affected2,359 at risk
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0014 events4 affected2,359 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0010 events0 affected2,359 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0015 events5 affected2,359 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0014 events4 affected2,359 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Nasal injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Post-traumatic neck syndrome	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Reactive gastropathy	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Testicular injury	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Blood glucose increased	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Gout	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG00112 events3 affected2,359 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Fracture nonunion	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0015 events4 affected2,359 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0011 events1 affected2,359 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Benign hydatidiform mole	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Castleman's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Extragonadal primary seminoma (pure)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Fibrosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Neurilemmoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Seminoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Testicular germ cell cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Transitional cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Aphasia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Arachnoid cyst	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Bell's palsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0016 events5 affected2,359 at risk
Cognitive disorder	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Demyelination	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dizziness	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0010 events0 affected2,359 at risk
Drug withdrawal convulsions	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Epilepsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0012 events2 affected2,359 at risk
Facial paresis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Headache	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0013 events3 affected2,359 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Hydrocephalus	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Idiopathic intracranial hypertension	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Intracranial mass	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Migraine	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Paraesthesia	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Partial seizures	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Polyneuropathy	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Postictal state	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Seizure	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected2,325 at risk EG0013 events3 affected2,359 at risk
Spinal cord compression	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Syncope	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abortion incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0014 events4 affected2,359 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Cephalo-pelvic disproportion	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected2,325 at risk EG0012 events2 affected2,359 at risk
Foetal death	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0013 events3 affected2,359 at risk
Foetal distress syndrome	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0004 events4 affected2,325 at risk EG0015 events5 affected2,359 at risk
Gestational hypertension	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Haemorrhage in pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Oligohydramnios	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Premature delivery	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Premature labour	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Premature rupture of membranes	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Prolonged labour	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0012 events2 affected2,359 at risk
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Umbilical cord prolapse	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Acute psychosis	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Affective disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Agitation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events1 affected2,359 at risk
Alcoholism	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Anxiety	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0015 events3 affected2,359 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0011 events1 affected2,359 at risk
Burnout syndrome	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events1 affected2,359 at risk
Cardiovascular somatic symptom disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Completed suicide	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0015 events5 affected2,359 at risk
Conversion disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Delirium	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Depression	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0009 events8 affected2,325 at risk EG00118 events13 affected2,359 at risk
Depression suicidal	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0011 events1 affected2,359 at risk
Drug abuse	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Drug dependence	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Hallucination	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Homicidal ideation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Intentional self-injury	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Major depression	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0008 events7 affected2,325 at risk EG0013 events3 affected2,359 at risk
Mental disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Panic attack	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Persecutory delusion	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Psychiatric decompensation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0003 events2 affected2,325 at risk EG0013 events2 affected2,359 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Schizophrenia	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0013 events2 affected2,359 at risk
Self-injurious ideation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Substance abuse	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0013 events3 affected2,359 at risk
Substance-induced mood disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0006 events3 affected2,325 at risk EG0014 events3 affected2,359 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG00022 events14 affected2,325 at risk EG00122 events16 affected2,359 at risk
Suicide attempt	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG00034 events24 affected2,325 at risk EG00122 events20 affected2,359 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG00011 events11 affected2,325 at risk EG0016 events6 affected2,359 at risk
Anuria	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
End stage renal disease	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0013 events3 affected2,359 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0014 events4 affected2,359 at risk
Nephropathy	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Renal colic	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Renal failure	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0012 events2 affected2,359 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Urinary retention	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Abnormal uterine bleeding	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Cystocele	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Genital rash	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Priapism	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Testicular pain	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Uterine adhesions	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0005 events4 affected2,325 at risk EG0018 events5 affected2,359 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0011 events1 affected2,359 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0003 events3 affected2,325 at risk EG0015 events5 affected2,359 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Restrictive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Tracheomalacia	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Panniculitis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Xanthoma	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Homicide	Social circumstances	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Substance use	Social circumstances	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Appendicectomy	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0012 events2 affected2,359 at risk
Aortic aneurysm	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Aortitis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,325 at risk EG0011 events1 affected2,359 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0005 events5 affected2,325 at risk EG0015 events3 affected2,359 at risk
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Hypertensive crisis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0010 events0 affected2,359 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,325 at risk EG0011 events1 affected2,359 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0002 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk
Vena cava thrombosis	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,325 at risk EG0010 events0 affected2,359 at risk

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

ID	Title	Description
BG000	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
BG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.
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	Early ART	Initiate ART immediately following randomization All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	66	2,325	428	2,325	0	0
EG001	Deferred ART	Defer ART until the CD4+ count declines to <350 cells/cu mm or AIDS develops All licensed antiretroviral medications: In both arms, participants may be prescribed any licensed antiretroviral medication, in accordance with national treatment guidelines. The nature of the intervention is the timing of when to begin treatment with these medications, as described in the two treatment arms.	85	2,359	500	2,359	0	0