Study to Evaluate the Safety and Efficacy of E/C/F/TAF Ve... | NCT01797445

ID	Type	Description	Link
2013-000102-37	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
E/C/F/TAF (Double-Blind)	Experimental	E/C/F/TAF plus E/C/F/TDF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.	Drug: E/C/F/TAF Drug: E/C/F/TDF Placebo
E/C/F/TDF (Double-Blind)	Active Comparator	E/C/F/TDF plus E/C/F/TAF placebo for 144 weeks After 144 weeks, participants will continue to take their blinded study drug until treatment assignments have been unblinded.	Drug: E/C/F/TDF Drug: E/C/F/TAF Placebo
Open-Label E/C/F/TAF	Experimental	After the unblinding visit, in countries where E/C/F/TAF is not commercially available, participants (except in UK) who complete 144 weeks of study will be given the option to receive open-label E/C/F/TAF and attend study visits every 12 weeks until it becomes commercially available, or until Gilead terminates the study in that country.	Drug: E/C/F/TAF

Name	Type	Description	Arm Group Labels	Other Names
E/C/F/TAF	Drug	150/150/200/10 mg FDC tablet administered orally once daily	E/C/F/TAF (Double-Blind) Open-Label E/C/F/TAF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.	Week 96

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening
No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), or post-exposure prophylaxis (PEP) up to 6 months prior to screening
Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir DF
Normal electrocardiogram (ECG)
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance
Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 × ULN
Males and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug
Females who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing
Females who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range
Age ≥ 18 years

Key Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody positive
Individuals experiencing decompensated cirrhosis
Females who are breastfeeding
Positive serum pregnancy test
Have an implanted defibrillator or pacemaker
Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements
Participation in any other clinical trial (including observational trials) without prior approval
Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Name	Affiliation	Role
Gilead Study Director	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
Spectrum Medical Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25890673	Result	Sax PE, Wohl D, Yin MT, Post F, DeJesus E, Saag M, Pozniak A, Thompson M, Podzamczer D, Molina JM, Oka S, Koenig E, Trottier B, Andrade-Villanueva J, Crofoot G, Custodio JM, Plummer A, Zhong L, Cao H, Martin H, Callebaut C, Cheng AK, Fordyce MW, McCallister S; GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Lancet. 2015 Jun 27;385(9987):2606-15. doi: 10.1016/S0140-6736(15)60616-X. Epub 2015 Apr 15.
29627709

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	E/C/F/TAF	Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks. Open-Label Extension Phase: After the unblinding visit, in countries where E/C/F/TAF FDC was not commercially available, participants (except in UK) were given the option to receive the open-label E/C/F/TAF FDC until it became commercially available, or until Gilead terminated the study in that country.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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
	OG00091.6 OG00188.5

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	Null hypothesis: the E/C/F/TAF group was ≥ 12% worse than the E/C/F/TDF group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48; alternative hypothesis: the E/C/F/TAF group was < 12% worse than the E/C/F/TDF group.	Cochran-Mantel-Haenszel	P-value was from the Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA (≤ 100,000 or > 100,000 copies/mL) and region (US vs ex-US).	0.13		Difference in Percentages	3.1			2-Sided	95.002	-1.0	7.1			The difference in percentages and its 95.002% confidence interval (CI) were calculated based on the Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA and region stratum.

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Weeks 48 and 96

The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

Participants in the Full Analysis Set were analyzed.

Posted

Number

percentage of participants

Weeks 48 and 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count at Week 48

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

cells/µL

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ Cell Count at Week 96

Participants in the Full Analysis Set with available data were analyzed.

Posted

Mean

Standard Deviation

cells/µL

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

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

Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan.

The Hip DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline hip BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Hip BMD at Week 96

Hip BMD was assessed by DXA scan.

Participants in the Hip DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Spine BMD at Week 48

Spine BMD was assessed by DXA scan.

The Spine DXA Analysis Set included all participants who were randomized and received at least 1 dose of study drug, and have nonmissing baseline spine BMD values. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Spine BMD at Week 96

Spine BMD was assessed by DXA scan.

Participants in the Spine DXA Analysis Set were analyzed. Participants were grouped according to the treatment they actually received. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

percent change

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Creatinine at Week 48

The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

mg/dL

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Creatinine at Week 96

Participants in the Safety Analysis Set were analyzed. The missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Posted

Mean

Standard Deviation

mg/dL

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Treatment-emergent Proteinuria Through Week 48

Grades 1 (mild), 2 (moderate), and 3 (severe) were the highest treatment-emergent postbaseline grades for urine protein using the dipstick method. The worst postbaseline value is presented for each participant.

Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.

Posted

Number

percentage of participants

Baseline to Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Treatment-emergent Proteinuria Through Week 96

Participants in the Safety Analysis Set with at least 1 postbaseline urine protein value were analyzed.

Posted

Number

percentage of participants

Baseline to Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

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

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.

Participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

percent change

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

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

Urine RBP is a renal biomarker which is used to detect drug-induced kidney injury.

Participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

percent change

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 48

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.

Participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

percent change

Baseline; Week 48

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine Beta-2-microglobulin to Creatinine Ratio at Week 96

Urine Beta-2-microglobulin is a renal biomarker which is used to detect drug-induced kidney injury.

Participants in the Safety Analysis Set with available data were analyzed.

Posted

Median

Inter-Quartile Range

percent change

Baseline; Week 96

ID	Title	Description
OG000	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
OG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 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	E/C/F/TAF (Double-Blind Phase)	Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TAF group, who received E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks.	5	431	54	431	374	431
EG001	E/C/F/TDF (Double-Blind Phase)	Adverse events reported occurred during the Double-Blind Phase in participants from the E/C/F/TDF group, who received E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks.	4	435	68	435	366	435
EG002	Open-Label E/C/F/TAF From E/C/F/TAF	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TAF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.	0	141	4	141	32	141
EG003	Open-Label E/C/F/TAF From E/C/F/TDF	Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the E/C/F/TDF group and received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily.	0	119	2	119	27	119

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG0030 affected119 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Goitre	Endocrine disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Iridocyclitis	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Retinal detachment	Eye disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0010 affected435 at risk EG0021 affected141 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Palatal dysplasia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0013 affected435 at risk EG0020 affected141 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Chest pain	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0013 affected435 at risk EG0020 affected141 at risk EG003
Death	General disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0012 affected435 at risk EG0021 affected141 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Immune reconstitution inflammatory syndrome	Immune system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Abscess limb	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Anal abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Appendicitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0014 affected435 at risk EG0021 affected141 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Chorioretinitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Dengue fever	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Encephalitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Erysipelas	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0004 affected431 at risk EG0010 affected435 at risk EG0021 affected141 at risk EG003
Hepatitis A	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0010 affected435 at risk EG0021 affected141 at risk EG003
Herpes simplex	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Infectious colitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Lung abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Mastoiditis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Meningitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Meningitis meningococcal	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Orchitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Otitis externa	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Otitis media	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Penile abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Pneumonia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Rectal abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Scrotal abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Secondary syphilis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Sepsis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Shigella infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Vulval abscess	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
West Nile viral infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Wound infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Labelled drug-drug interaction medication error	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0013 affected435 at risk EG0020 affected141 at risk EG003
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Stab wound	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Alanine aminotransferase abnormal	Investigations	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Diabetic complication	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Intracranial pressure increased	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Migraine	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Nerve compression	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Sciatica	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Seizure	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Syncope	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Unresponsive to stimuli	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Acute psychosis	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Bipolar II disorder	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Depression	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0013 affected435 at risk EG0020 affected141 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Homicidal ideation	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Major depression	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG0002 affected431 at risk EG0012 affected435 at risk EG0020 affected141 at risk EG003
Renal haematoma	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Vaginal dysplasia	Reproductive system and breast disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0003 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG0000 affected431 at risk EG0011 affected435 at risk EG0020 affected141 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG0001 affected431 at risk EG0010 affected435 at risk EG0020 affected141 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.0)	Systematic Assessment	EG00029 affected431 at risk EG00124 affected435 at risk EG0022 affected141 at risk EG0032 affected119 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00033 affected431 at risk EG00134 affected435 at risk EG0020 affected141 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00024 affected431 at risk EG00133 affected435 at risk EG0020 affected141 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00099 affected431 at risk EG001114 affected435 at risk EG0020 affected141 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00023 affected431 at risk EG00115 affected435 at risk EG0021 affected141 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected431 at risk EG00127 affected435 at risk EG0021 affected141 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00078 affected431 at risk EG00186 affected435 at risk EG0021 affected141 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected431 at risk EG00119 affected435 at risk EG0021 affected141 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.0)	Systematic Assessment	EG00044 affected431 at risk EG00146 affected435 at risk EG0020 affected141 at risk EG003
Fatigue	General disorders	MedDRA (21.0)	Systematic Assessment	EG00053 affected431 at risk EG00152 affected435 at risk EG0021 affected141 at risk EG003
Pyrexia	General disorders	MedDRA (21.0)	Systematic Assessment	EG00037 affected431 at risk EG00132 affected435 at risk EG0020 affected141 at risk EG003
Bronchitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00038 affected431 at risk EG00126 affected435 at risk EG0022 affected141 at risk EG003
Chlamydial infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00024 affected431 at risk EG00120 affected435 at risk EG0021 affected141 at risk EG003
Folliculitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00019 affected431 at risk EG00126 affected435 at risk EG0022 affected141 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00023 affected431 at risk EG00121 affected435 at risk EG0020 affected141 at risk EG003
Gonorrhoea	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00026 affected431 at risk EG00120 affected435 at risk EG0021 affected141 at risk EG003
Influenza	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00025 affected431 at risk EG00118 affected435 at risk EG0021 affected141 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00068 affected431 at risk EG00175 affected435 at risk EG0025 affected141 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00022 affected431 at risk EG00125 affected435 at risk EG0020 affected141 at risk EG003
Sinusitis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00025 affected431 at risk EG00128 affected435 at risk EG0022 affected141 at risk EG003
Syphilis	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00042 affected431 at risk EG00144 affected435 at risk EG0022 affected141 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00087 affected431 at risk EG00182 affected435 at risk EG0022 affected141 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.0)	Systematic Assessment	EG00017 affected431 at risk EG00131 affected435 at risk EG0021 affected141 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00061 affected431 at risk EG00149 affected435 at risk EG0022 affected141 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00063 affected431 at risk EG00153 affected435 at risk EG0020 affected141 at risk EG003
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00034 affected431 at risk EG00138 affected435 at risk EG0022 affected141 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00031 affected431 at risk EG00126 affected435 at risk EG0022 affected141 at risk EG003
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.0)	Systematic Assessment	EG00029 affected431 at risk EG00125 affected435 at risk EG0020 affected141 at risk EG003
Dizziness	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00027 affected431 at risk EG00128 affected435 at risk EG0021 affected141 at risk EG003
Headache	Nervous system disorders	MedDRA (21.0)	Systematic Assessment	EG00098 affected431 at risk EG00180 affected435 at risk EG0024 affected141 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00034 affected431 at risk EG00143 affected435 at risk EG0020 affected141 at risk EG003
Depression	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00034 affected431 at risk EG00126 affected435 at risk EG0020 affected141 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (21.0)	Systematic Assessment	EG00051 affected431 at risk EG00137 affected435 at risk EG0021 affected141 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (21.0)	Systematic Assessment	EG00011 affected431 at risk EG00122 affected435 at risk EG0020 affected141 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00062 affected431 at risk EG00149 affected435 at risk EG0021 affected141 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00016 affected431 at risk EG00122 affected435 at risk EG0020 affected141 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.0)	Systematic Assessment	EG00025 affected431 at risk EG00139 affected435 at risk EG0020 affected141 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (21.0)	Systematic Assessment	EG00047 affected431 at risk EG00142 affected435 at risk EG0021 affected141 at risk EG003
Hypertension	Vascular disorders	MedDRA (21.0)	Systematic Assessment	EG00026 affected431 at risk EG00111 affected435 at risk EG0020 affected141 at risk EG003

Ancestor Terms

ID	Term
D000069547	Cobicistat
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D013844	Thiazoles
D013457	Sulfur Compounds
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
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
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	E/C/F/TAF	E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
BG001	E/C/F/TDF	E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
BG002	Total	Total of all reporting groups