Study to Evaluate the Safety and Efficacy of Emtricitabin... | NCT02842086

NCT02842086

ID	Type	Description	Link
2022-501763-40	Other Identifier	European Medicines Agency
2016-001399-31	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F/TAF	Experimental	F/TAF+ F/TDF placebo for at least 96 weeks	Drug: F/TAF Drug: F/TDF Placebo
F/TDF	Experimental	F/TDF+ F/TAF placebo for at least 96 weeks	Drug: F/TDF Drug: F/TAF Placebo
Open-label	Experimental	Once all participants have been on blinded treatment for at least 96 weeks, the study will be unblinded and participants will be offered the option to continue on open-label F/TAF treatment for 96 weeks.	Drug: F/TAF
Open-Label Extension	Experimental	Participants who remain on study at Open-label Week 96 will have the option to continue on open-label F/TAF treatment in the Open-label extension phase for 408 weeks.	Drug: F/TAF

Name	Type	Description	Arm Group Labels	Other Names
F/TAF	Drug	200/25 mg tablet administered orally once daily	F/TAF Open-Label Extension Open-label

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of HIV-1 Infection Per 100 Person Years (PY)	The incidence of HIV-1 infection rate per 100 PY was calculated as the number of participants who became HIV infected during the study after the first dose of study drug divided by the sum of all participants' years (where a year is 365.25 days) of follow-up while at risk of HIV infection during the study. HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab: Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)	When all participants completed minimum follow-up of 48 weeks and at least 50% of the participants completed 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 125 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase	Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.	Baseline, Week 48
Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase

Eligibility Module

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Beverly Hills	California	90211	United States

References Module

Citations

PubMed Identifier	Type	Citation
	Result	Hare B. The Phase 3 DISCOVER Study: Daily F/TAF or F/TDF for HIV Preexposure Prophylaxis [Presentation]. Conference on Retroviruses and Opportunistic Infections (CROI); 2019 04-07 March; Seattle, WA.
32711800	Result	Mayer KH, Molina JM, Thompson MA, Anderson PL, Mounzer KC, De Wet JJ, DeJesus E, Jessen H, Grant RM, Ruane PJ, Wong P, Ebrahimi R, Zhong L, Mathias A, Callebaut C, Collins SE, Das M, McCallister S, Brainard DM, Brinson C, Clarke A, Coll P, Post FA, Hare CB. Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER): primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial. Lancet. 2020 Jul 25;396(10246):239-254. doi: 10.1016/S0140-6736(20)31065-5.
39008999

Label	URL
Gilead Clinical Trials Website	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Descovy (DVY)	Blinded Phase: Descovy (DVY; emtricitabine/tenofovir alafenamide [F/TAF] 200/25 mg) fixed-dose combination (FDC) tablet plus placebo-to-match Truvada (TVD) (emtricitabine/tenofovir disoproxil fumarate [F/TDF] 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 19, 2021	Jun 28, 2022

Arm/Group Information

ID	Title	Description
BG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
BG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.160(0.064 to 0.330) OG0010.342(0.191 to 0.564)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Noninferiority was assessed using a 95.003% confidence interval (CI) constructed using a generalized model associated with a Poisson distribution and logarithmic link with the treatment group being the main effect and with a noninferiority margin of 1.62.					Rate Ratio	0.468			2-Sided	95.003	0.191	1.149					Non-Inferiority	Noninferiority of DVY to TVD was to be concluded if the upper bound of the 2-sided 95.003% CI of the rate ratio (DVY group over TVD group) in the HIV infection incidence rate was less than 1.62.

Secondary

Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Spine BMD at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants were grouped according to the treatment they actually received. Participants with available data were analyzed.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants

Secondary

Percent Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio at Week 48 in the Blinded Phase

Percent Change = Change from baseline at Week 48 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Participants in Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants by Urine Protein (UP) and Urine Protein to Creatinine Ratio (UPCR) Categories at Week 48 in the Blinded Phase

The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.

Participants in Safety Analysis Set with available data were analyzed.

Posted

Count of Participants

Participants

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Creatinine at Week 48 in the Blinded Phase

Participants in Safety Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 48

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Incidence of HIV-1 Infection Per 100 PY

HIV-1 infection is defined by one or more of the following criteria of contributing HIV tests performed via central lab or local lab:

Serologic evidence of seroconversion (reactive screening HIV Antigen/Antibody or Antibody test, confirmed by reactive HIV-1/HIV-2 differentiation assay), excluding HIV vaccinated participants, or
Virologic evidence of HIV-1 infection (positive qualitative HIV-1 RNA test or any detectable quantitative HIV-1 RNA test), or
Evidence of acute HIV-1 infection (reactive p24 Antigen or positive qualitative or quantitative RNA, in the absence of reactive HIV-1 Antibody results)

Participants in Full Analysis Set were analyzed.

Posted

Number

95% Confidence Interval

HIV-1 infections per 100 PY

When all participants have 96 weeks of follow-up after randomization or permanently discontinued from the study (maximum 157 weeks)

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Secondary

Percent Change From Baseline in Hip BMD at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

Participants in Hip DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Spine BMD at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

Participants in Spine DXA Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

Percent Change

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine Beta-2-Microglobulin to Creatinine Ratio at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Participants in Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine RBP to Creatinine Ratio at Week 96 in the Blinded Phase

Percent Change = Change from baseline at Week 96 visit/value at baseline * 100%.

For urine creatinine, value of < 1 was handled as a missing value in its summary and the calculation of related ratios.

Participants in Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

Percent Change

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Number of Participants by UP and UPCR Categories at Week 96 in the Blinded Phase

The UPCR was only calculated when corresponding UP ≥ 4.0 mg/dL. The UPCR "≤ 200 mg/g" category includes both participants with UP < 4.0 mg/dL and participants with UPCR ≤ 200 mg/g.

Participants in Safety Analysis Set with available data were analyzed.

Posted

Count of Participants

Participants

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Creatinine at Week 96 in the Blinded Phase

Participants in Safety Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

mg/dL

Baseline, Week 96

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Participants in Safety Analysis Set were analyzed.

Posted

Number

percentage of participants

First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality

Participants in Safety Analysis Set with available data were analyzed.

Posted

Number

percentage of participants

First dose date up to the data cut for end of blinded treatment (maximum: 157 weeks)

ID	Title	Description
OG000	Descovy (DVY)	Blinded Phase: DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.
OG001	Truvada (TVD)	Blinded Phase: TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Descovy (DVY)	DVY (F/TAF 200/25 mg) FDC tablet plus placebo-to-match TVD (F/TDF 200/300 mg) FDC tablet administered orally once daily for at least 96 weeks.	3	2,694	202	2,694	2,258	2,694
EG001	Truvada (TVD)	TVD (F/TDF 200/300 mg) FDC tablet plus placebo-to-match DVY (F/TAF 200/25 mg) FDC tablet administered orally once daily for at least 96 weeks.	3	2,693	186	2,693	2,229	2,693

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Angina pectoris	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0017 affected2,693 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Cardiac flutter	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Left ventricular failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0013 affected2,693 at risk
Myocarditis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Palpitations	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Pectus excavatum	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Sickle cell disease	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Hyperparathyroidism primary	Endocrine disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ocular myasthenia	Eye disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0012 affected2,693 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Colitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Constipation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Cyclic vomiting syndrome	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0013 affected2,693 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Enlarged uvula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Enteritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Mesenteritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Proctitis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Rectal lesion	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Volvulus	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Vomiting	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0014 affected2,693 at risk
Death	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Non-cardiac chest pain	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0011 affected2,693 at risk
Oedema peripheral	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Pyrexia	General disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Sudden death	General disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Treatment failure	General disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0012 affected2,693 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Amyloidosis	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Abdominal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Abscess limb	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Abscess oral	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Anal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0013 affected2,693 at risk
Appendicitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0009 affected2,694 at risk EG00110 affected2,693 at risk
Appendicitis perforated	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Brain abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Breast abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0007 affected2,694 at risk EG0015 affected2,693 at risk
Cellulitis of male external genital organ	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Cholecystitis infective	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Device related infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Diverticulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0003 affected2,694 at risk EG0013 affected2,693 at risk
Endocarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Epididymitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Erysipelas	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Eye infection gonococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0014 affected2,693 at risk
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Gastroenteritis shigella	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Giardiasis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Gonorrhoea	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Groin abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Hepatitis A	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0006 affected2,694 at risk EG0012 affected2,693 at risk
Infected bite	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Infective tenosynovitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0011 affected2,693 at risk
Large intestine infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Localised infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Lymphogranuloma venereum	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Malaria	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Measles	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Meningitis streptococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Neurosyphilis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Orchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Osteomyelitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Parotid abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Perineal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Perirectal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Peritonitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pharyngeal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Plasmodium falciparum infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0005 affected2,694 at risk EG0014 affected2,693 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Postoperative wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Proctitis chlamydial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pyelonephritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Rectal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Scrotal abscess	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0003 affected2,694 at risk EG0011 affected2,693 at risk
Septic shock	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Shigella infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Tonsillitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0012 affected2,693 at risk
Tooth infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0013 affected2,693 at risk
Viral pericarditis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Viral rash	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Wound infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0013 affected2,693 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Deep vein thrombosis postoperative	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0012 affected2,693 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 affected2,694 at risk EG0011 affected2,693 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0003 affected2,694 at risk EG0011 affected2,693 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Reactive gastropathy	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0004 affected2,694 at risk EG0011 affected2,693 at risk
Scrotal haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Tendon injury	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0012 affected2,693 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Astrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Carcinoid tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0003 affected2,694 at risk EG0010 affected2,693 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Testicular seminoma (pure)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Cerebral venous sinus thrombosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Facial paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Loss of consciousness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Migraine	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Myelitis transverse	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Nerve compression	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Paraesthesia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Partial seizures	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Polyneuropathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Presyncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Radiculopathy	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Sciatica	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Seizure	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Speech disorder	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Syncope	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0012 affected2,693 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Device dislocation	Product Issues	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Acute psychosis	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Alcohol use disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Alcoholism	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Anxiety	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Delirium	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Delusion	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0005 affected2,694 at risk EG0013 affected2,693 at risk
Intentional self-injury	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Major depression	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Panic attack	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Personality disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0013 affected2,693 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Substance abuse	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0011 affected2,693 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0008 affected2,694 at risk EG0015 affected2,693 at risk
Suicide attempt	Psychiatric disorders	MedDRA 22.1	Systematic Assessment	EG0005 affected2,694 at risk EG0011 affected2,693 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0007 affected2,694 at risk EG0012 affected2,693 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0012 affected2,693 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Renal colic	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Renal infarct	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0012 affected2,693 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Priapism	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0011 affected2,693 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Testicular torsion	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0011 affected2,693 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0012 affected2,693 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Vocal cord thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Alcohol use	Social circumstances	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Ligament operation	Surgical and medical procedures	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Medical device removal	Surgical and medical procedures	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0002 affected2,694 at risk EG0010 affected2,693 at risk
Haematoma	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk
Hypertension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 affected2,694 at risk EG0011 affected2,693 at risk
Hypotension	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 affected2,694 at risk EG0010 affected2,693 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000479 affected2,694 at risk EG001451 affected2,693 at risk
Nausea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG000209 affected2,694 at risk EG001204 affected2,693 at risk
Fatigue	General disorders	MedDRA 22.1	Systematic Assessment	EG000180 affected2,694 at risk EG001181 affected2,693 at risk
Anal chlamydia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000890 affected2,694 at risk EG001902 affected2,693 at risk
Gastroenteritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000171 affected2,694 at risk EG001141 affected2,693 at risk
Influenza	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000145 affected2,694 at risk EG001143 affected2,693 at risk
Nasopharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000399 affected2,694 at risk EG001402 affected2,693 at risk
Oropharyngeal gonococcal infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000871 affected2,694 at risk EG001838 affected2,693 at risk
Pharyngeal chlamydia infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000215 affected2,694 at risk EG001186 affected2,693 at risk
Pharyngitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000166 affected2,694 at risk EG001108 affected2,693 at risk
Proctitis gonococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000805 affected2,694 at risk EG001797 affected2,693 at risk
Syphilis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000413 affected2,694 at risk EG001392 affected2,693 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000402 affected2,694 at risk EG001346 affected2,693 at risk
Urethritis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000193 affected2,694 at risk EG001189 affected2,693 at risk
Urethritis chlamydial	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000346 affected2,694 at risk EG001314 affected2,693 at risk
Urethritis gonococcal	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG000259 affected2,694 at risk EG001255 affected2,693 at risk
Exposure to communicable disease	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG000554 affected2,694 at risk EG001548 affected2,693 at risk
Headache	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG000206 affected2,694 at risk EG001209 affected2,693 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG000152 affected2,694 at risk EG001136 affected2,693 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG000172 affected2,694 at risk EG001165 affected2,693 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 22.1	Systematic Assessment	EG000136 affected2,694 at risk EG001122 affected2,693 at risk

Ancestor Terms

ID	Term
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations

ID	Term
C000613801	emtricitabine tenofovir alafenamide
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination