Multicenter, Randomized, Double-Blind, Double-Dummy, Phas... | NCT00708162

ID	Type	Description	Link
2007-004225-26	EudraCT Number

Label	Type	Description	Intervention Names
Elvitegravir	Experimental	EVG 85 mg or 150 mg + RAL placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their background regimen will receive EVG 85 mg; all other participants will receive EVG 150 mg.	Drug: Elvitegravir Drug: RAL placebo Drug: Background regimen
Raltegravir	Active Comparator	RAL 800 mg (400 mg twice daily) + EVG placebo + background regimen in the Randomized Phase, followed by EVG 85 mg or 150 mg + background regimen in the Open-Label Phase. Participants receiving LPV/r or ATV/r as part of their background regimen in the Open-Label Phase will receive EVG 85 mg; all other participants will receive EVG 150 mg.	Drug: Raltegravir Drug: EVG placebo Drug: Background regimen

Name	Type	Description	Arm Group Labels	Other Names
Elvitegravir	Drug	Elvitegravir (EVG) tablet administered orally once daily with food	Elvitegravir

Measure	Description	Time Frame
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.	Week 48

Measure	Description	Time Frame
Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96	The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

Name	Affiliation	Role
Javier Szwarcberg, MD, MPH	Gilead Sciences	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Southwest Center for HIV/AIDS		Phoenix	Arizona	85006	United States
Health for Life Clinic, PLLC

PubMed Identifier	Type	Citation	Retractions
22015077	Result	Molina JM, Lamarca A, Andrade-Villanueva J, Clotet B, Clumeck N, Liu YP, Zhong L, Margot N, Cheng AK, Chuck SL; Study 145 Team. Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. Lancet Infect Dis. 2012 Jan;12(1):27-35. doi: 10.1016/S1473-3099(11)70249-3. Epub 2011 Oct 18.

ID	Title	Description
FG000	Elvitegravir	Elvitegravir (EVG) 85 or 150 mg tablet once daily plus raltegravir (RAL) placebo plus background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

ITT Analysis Set

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000351 OG001351

Title

Denominators

Categories

Title	Measurements
	OG00059.0 OG00157.8

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The planned sample size of 700 HIV-1 infected participants, (350 in each group) was estimated to provide at least 85% power to establish noninferiority in the percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL through Week 48. For sample size and power computation, it was assumed that both elvitegravir and raltegravir arms have a response rate of 0.74, that a noninferiority margin was 0.10, and that the significance level of the test was 1-sided 0.025 level.					Difference in percentages	1.1			2-Sided	95	-6.0	8.2			The difference in percentages and its 95% confidence interval (CI) were based on stratum-adjusted HIV-1 RNA level and the class of second agent (NRTI or other classes) using Mantel-Haenszel (MH) proportions and normal approximation.

Secondary

Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

ITT Analysis Set

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

ITT Analysis Set

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96

The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

ITT Analysis Set

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)

Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.

ITT Analysis Set

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)

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

ITT Analysis Set

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96

The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

ITT Analysis Set

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.

ITT Analysis Set

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants

Secondary

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

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.

ITT Analysis Set

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.

ITT Analysis Set

Posted

Number

percentage of participants

Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.

ITT Analysis Set

Posted

Number

percentage of participants

Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HIV-1 RNA at Week 48

The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.

Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline to Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in HIV-1 RNA at Week 96

The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.

Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline to Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4 Cell Count at Week 48

The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.

Participants in the ITT Analysis Set with evaluable change data at Week 48 were analyzed.

Posted

Mean

Standard Deviation

cells/mm^3

Baseline to Week 48

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4 Cell Count at Week 96

The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.

Participants in the ITT Analysis Set with evaluable change data at Week 96 were analyzed.

Posted

Mean

Standard Deviation

cells/mm^3

Baseline to Week 96

ID	Title	Description
OG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
OG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coombs positive haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Cardiac arrest	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Cardiac failure	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Cardiac tamponade	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Coronary artery disease	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Mitral valve prolapse	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Myocardial infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0023 affected505 at risk
Pericardial effusion	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pericarditis	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Haemophilia	Congenital, familial and genetic disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Basedow's disease	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cushing's syndrome	Endocrine disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Retinal detachment	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0012 affected358 at risk EG0021 affected505 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Ascites	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Colitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Gastritis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Odynophagia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0014 affected358 at risk EG0024 affected505 at risk
Drug withdrawal syndrome	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Non-cardiac chest pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Hypersensitivity	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Immune reconstitution inflammatory syndrome	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Abscess limb	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Acute hepatitis B	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Anal abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Appendicitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Arthritis infective	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Biliary sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Breast abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0014 affected358 at risk EG0023 affected505 at risk
Bursitis infective	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Candida infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0005 affected354 at risk EG0015 affected358 at risk EG0028 affected505 at risk
Enterocolitis bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Epididymitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Extradural abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Folliculitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Genital herpes	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Hepatitis A	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Herpes simplex	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Herpes zoster	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Infectious colitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Influenza	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Liver abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Meningitis aseptic	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Muscle abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Neurosyphilis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Osteomyelitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Parotid abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Periorbital cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Perirectal abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00012 affected354 at risk EG0017 affected358 at risk EG00215 affected505 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Postoperative wound infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pyelonephritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Septic shock	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Skin infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Spinal cord abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Streptococcal sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Urosepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Viral infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0012 affected358 at risk EG0023 affected505 at risk
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Skull fractured base	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0022 affected505 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Liver function test abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Hyperosmolar hyperglycaemic state	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Anal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Anal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Hodgkin's disease stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Oral papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Primary effusion lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Queyrat erythroplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Aphasia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Ataxia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Carotid artery dissection	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cerebral infarction	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0012 affected358 at risk EG0022 affected505 at risk
Dizziness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Embolic stroke	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Epilepsy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Hemiparesis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Loss of consciousness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Partial seizures	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Seizure	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0012 affected358 at risk EG0023 affected505 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0023 affected505 at risk
Syncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0010 affected358 at risk EG0027 affected505 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Acute psychosis	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Alcohol abuse	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Anxiety	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Confusional state	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Drug dependence	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Homicidal ideation	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Major depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Mental status changes	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Substance abuse	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0021 affected505 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0003 affected354 at risk EG0014 affected358 at risk EG0024 affected505 at risk
Suicide attempt	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0011 affected358 at risk EG0025 affected505 at risk
Calculus urinary	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0012 affected358 at risk EG0020 affected505 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Renal tubular acidosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0011 affected358 at risk EG0022 affected505 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 affected354 at risk EG0011 affected358 at risk EG0025 affected505 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Pulmonary cavitation	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Aortic stenosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Haemodynamic instability	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Haemorrhage	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Hypertensive crisis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0011 affected358 at risk EG0020 affected505 at risk
Shock	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 affected354 at risk EG0010 affected358 at risk EG0021 affected505 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00024 affected354 at risk EG00118 affected358 at risk EG00240 affected505 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG000120 affected354 at risk EG00177 affected358 at risk EG002158 affected505 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00014 affected354 at risk EG0019 affected358 at risk EG00228 affected505 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00045 affected354 at risk EG00141 affected358 at risk EG00261 affected505 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG00022 affected354 at risk EG00128 affected358 at risk EG00230 affected505 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG00039 affected354 at risk EG00125 affected358 at risk EG00255 affected505 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected354 at risk EG00119 affected358 at risk EG00229 affected505 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00034 affected354 at risk EG00134 affected358 at risk EG00257 affected505 at risk
Folliculitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00018 affected354 at risk EG0017 affected358 at risk EG00225 affected505 at risk
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00015 affected354 at risk EG0017 affected358 at risk EG00228 affected505 at risk
Influenza	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00015 affected354 at risk EG00110 affected358 at risk EG00230 affected505 at risk
Nasopharyngitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00040 affected354 at risk EG00132 affected358 at risk EG00256 affected505 at risk
Oral herpes	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00015 affected354 at risk EG0016 affected358 at risk EG00226 affected505 at risk
Sinusitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00028 affected354 at risk EG00128 affected358 at risk EG00248 affected505 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00075 affected354 at risk EG00159 affected358 at risk EG002116 affected505 at risk
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG00028 affected354 at risk EG00135 affected358 at risk EG00252 affected505 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG00012 affected354 at risk EG00120 affected358 at risk EG00226 affected505 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00030 affected354 at risk EG00128 affected358 at risk EG00257 affected505 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00042 affected354 at risk EG00136 affected358 at risk EG00268 affected505 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected354 at risk EG00113 affected358 at risk EG00228 affected505 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00014 affected354 at risk EG00111 affected358 at risk EG00226 affected505 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00028 affected354 at risk EG00125 affected358 at risk EG00248 affected505 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG00049 affected354 at risk EG00137 affected358 at risk EG00263 affected505 at risk
Anxiety	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG00016 affected354 at risk EG0019 affected358 at risk EG00233 affected505 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG00033 affected354 at risk EG00133 affected358 at risk EG00249 affected505 at risk
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG00026 affected354 at risk EG00121 affected358 at risk EG00242 affected505 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG00041 affected354 at risk EG00147 affected358 at risk EG00265 affected505 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG00018 affected354 at risk EG00110 affected358 at risk EG00224 affected505 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG00028 affected354 at risk EG00129 affected358 at risk EG00240 affected505 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG00014 affected354 at risk EG00126 affected358 at risk EG00239 affected505 at risk

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

ID	Term
D011760	Pyrrolidinones
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Elvitegravir	EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
BG001	Raltegravir	RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Elvitegravir	Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during the Randomized Phase EVG 85 or 150 mg tablet once daily plus RAL placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.	73	354	279	354
EG001	Raltegravir	Adverse events in this reporting group are those experienced by participants in the Raltegravir group during the Randomized Phase RAL 400 mg tablet twice daily plus EVG placebo plus background regimen (1 fully-active RTV-boosted PI plus 1 or 2 additional agents) in the Randomized Phase, followed by EVG 85 or 150 mg tablet once daily plus background regimen in the Open-Label Phase.	86	358	250	358
EG002	All Elvitegravir	Adverse events in this reporting group are those experienced by participants in the Elvitegravir group during both the Randomized Phase and Open-Label Phase, and those experienced by participants in the Raltegravir group following switch to EVG in the Open-Label Phase only.	127	505	394	505