Comparative Study of Three NNRTI-Sparing HAART Regimens | NCT00811954

NCT00811954

ID	Type	Description	Link
1U01AI068636	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Institute of Allergy and Infectious Diseases (NIAID)	NIH
Bristol-Myers Squibb	INDUSTRY
Gilead Sciences	INDUSTRY
Merck Sharp & Dohme LLC

Oversight Module

Description Module

Detailed Description

Of the five anti-HIV drug classes, four were recommended as first-line regimens for patients who have never received anti-HIV treatment before (treatment naive): nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), Integrase Inhibitors (INIs) and protease inhibitors (PIs). The U.S. Department of Health and Human Services (HHS) guidelines recommend that treatment-naive HIV infected patients be treated with a triple drug regimen that includes 2 NRTIs + 1 NNRTI, 2 NRTIs + INI, or 2 NRTIs + 1 PI as their initial treatment regimen.

According to data, an efavirenz (EFV)-containing regimen (2 NRTIs + 1 NNRTI, with EFVas the NNRTI) requires fewer pills for the patient, has mild and few side effects, and is more effective in reducing viral load than other regimens, making it the preferred choice for most patients. However, for some patients, an EFV-containing regimen is not feasible due to side effects, acquired NNRTI-resistant HIV virus, or other undesirable effects. For these patients, it is necessary to find alternative regimens with comparable safety and efficacy. This study examined how well different combinations of anti-HIV drugs work, including safety and drug tolerability for various combinations.

This was a phase III, prospective, randomized study. Participants was randomly assigned to one of three different groups (treatment arms)-A, B, or C -each representing a different drug combination regimen, none of which contained an NNRTI.

Arm A: Atazanavir (ATV) + Ritonavir (RTV) + Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF)

Arm B: Raltegravir (RAL) + FTC/TDF

Arm C: Darunavir (DRV) + RTV + FTC/TDF

The duration of this study was between 96 and 192 weeks, depending on when the participant enrolled. There were a total of 1,809 participants, approximately 600 per treatment arm. Screening and pre-entry evaluations must occur prior to the participant starting any study medication, treatments, or interventions. Participants were randomly assigned to their treatment groups at the entry visit and must begin treatment within 72 hours of randomization. Participants was told which group they were in and what medications they were administered. The study drugs were distributed at entry. All drugs were provided by the study with the exception of RTV, which would have to be obtained through the participant's primary care physician (Group A or C). If a participant was unable to tolerate any of the study medications during the course of the study then their doctor could switch them to another regimen.

During the study, participants was asked to return to the clinic at Weeks 4, 8, 16, 24, 36, and 48 and then every 16 weeks until the end of the study. They were also contacted by telephone during Week 2 to check on their status. Visits were last about 1 hour. At most visits, participants had a physical exam and answered questions about any medications they were taken. Additionally, participants completed questionnaires addressing their smoking and alcohol habits, had blood drawn, and were asked to give urine samples. At some visits, participants had to come to the clinic without having eaten for 8 hours. If the participant was female and able to become pregnant, a pregnancy test might be given at any visit if pregnancy was suspected.

Some participants of A5257 were asked to participate in an optional metabolic substudy A5260s. This substudy took place at only some study sites and continued last up to 144 weeks, including time on A5257. The primary focus of this substudy was to examine carotid artery intima-media thickness (CIMT) as it relates to both RTV- and RAL-containing regimens. Randomization, stratification, treatment assignments, and study visits were as per A5257.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A: ATV/RTV + FTC/TDF	Experimental	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.	Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Ritonavir Drug: Atazanavir
Arm B: RAL + FTC/TDF	Experimental	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.	Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Raltegravir
Arm C: DRV/RTV + FTC/TDF	Experimental	FTC/TDF, darunavir (DRV), and RTV, orally, once daily.	Drug: Emtricitabine/tenofovir disoproxil fumarate Drug: Darunavir Drug: Ritonavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emtricitabine/tenofovir disoproxil fumarate	Drug	200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally daily. A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative Probability of First Virologic Failure by Week 96	The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96. Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.	From study entry to week 96
Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96	The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.	From study entry to week 96

Secondary Outcomes

Measure	Description	Time Frame
Cumulative Incidence of First Adverse Event by Week 96	The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event. The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1 infected
No evidence of any exclusionary mutations defined as any major NRTI or PI resistance-associated mutation on any genotype or evidence of significant NRTI or PI resistance on any phenotype performed at any time prior to study entry. NNRTI-associated resistance mutations are not excluded. More information on this criterion can be found in the study protocol.
No prior anti-HIV therapy. More information on this criterion can be found in the study protocol.
Viral load is 1000 copies/mL or higher, as measured within 90 days prior to study entry
Certain laboratory values obtained within 60 days prior to study entry
Ability to obtain RTV by prescription
Completed cardiovascular risk assessment. More information on this criterion can be found in the study protocol.
Must agree to use acceptable forms of contraception while receiving study drugs and for 6 weeks after stopping the medications. More information on this criterion is available in the protocol.
Negative pregnancy test within 72 hours before initiating antiretroviral medication
Participating in research at any AIDS Clinical Trial Group (ACTG) clinical research site or select International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) group sites
Ability and willingness of subject or legal guardian/representative to give written informed consent

Exclusion Criteria:

Use of immunomodulators, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry. Those using stable physiologic glucocorticoid doses, a short course of pharmacologic glucocorticoid, corticosteroids for acute therapy treating an opportunistic infection, inhaled or topical corticosteroids, or granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) will not be excluded.
Known allergy or sensitivity to study drugs or their ingredients. A history of sulfa allergy is not excluded.
Any condition that, in the opinion of the investigator, would compromise the participant's ability to participate in the study
Serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 7 days prior to study entry
Requirement for any current medications that are prohibited with any study drugs
Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness
Any prior use of entecavir for treatment of hepatitis B for greater than 8 weeks while the participant was known to be HIV infected
Presence of decompensated cirrhosis
Pregnant or breastfeeding

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Jeffrey L. Lennox, MD	Emory HIV/AIDS CTU	Study Chair
Judith Silverstein Currier, MD, MSc	UCLA AIDS Prevention & Treatment CTU	Study Chair
Raphael Landovitz, MD, MSc	UCLA AIDS Prevention & Treatment CTU	Study Chair
Igho Ofotokun, MD	Emory HIV/AIDS CTU	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Therapeutics CRS		Birmingham	Alabama	35294-2050	United States
Miller Children's Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17720662	Background	Bartlett JA, Chen SS, Quinn JB. Comparative efficacy of nucleoside/nucleotide reverse transcriptase inhibitors in combination with efavirenz: results of a systematic overview. HIV Clin Trials. 2007 Jul-Aug;8(4):221-6. doi: 10.1310/hct0804-221.
18641035	Background	Duvivier C, Ghosn J, Assoumou L, Soulie C, Peytavin G, Calvez V, Genin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Arm A: ATV/RTV + FTC/TDF

Arm B: RAL + FTC/TDF

Arm C: DRV/RTV + FTC/TDF

Intention to treat: All eligible participants were included in the baseline characteristics.

Arm/Group Information

ID	Title	Description
BG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
BG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
BG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0002 BG0012 BG0022 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00038± 11 BG00137± 11 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000144 BG001148 BG002

Race/Ethnicity, Customized

Race/Ethnicity was collected prior to study entry

Number

participants

Title

Denominators

Categories

White Non-Hispanic

Title	Measurements
	BG000212 BG001212 BG002

HIV-1 RNA

HIV-1 RNA was calculated as the geometric mean of the two most recent HIV-1 RNA (log 10 copies/mL) obtained on or before study entry. In the event that these two values differed by more than 1log10 copy/mL, the outlying value (based on review of all HIV-1 RNA levels available prior to study entry by the study virologist) was excluded and baseline determined by the remaining sample. Note that screening HIV-1 RNA values were not sued in the calculation of baseline HIV-1 RNA levels.

Mean

Standard Deviation

log10 copies/mL

Title

Denominators

Categories

Title	Measurements
	BG0004.6± 0.7 BG001

CD4+ T-cell count

CD4+ T-cell counts were calculated as the mean of the two most recent values available on or before study entry.

Mean

Standard Deviation

cells/mm^3

Title

Denominators

Categories

Title	Measurements
	BG000309± 189 BG001306± 199

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

Cumulative Probability of First Virologic Failure by Week 96

The Kaplan-Meier estimate of the cumulative probability of virologic failure by week 96.

Time to virologic failure was defined as the first time from study entry to the first of two consecutive HIV-1 RNA >1000 copies/mL at or after week 16 and before week 24, or >200 copies/mL at or after week 24. Week 16 is defined to occur between 14 (98 days) and 18 weeks (126 days) after study entry, week 24 is defined to occur between 22 (154 days) and 26 (182 days) after study entry, and week 96 is defined to occur between 88 (616 days) and 104 (728 days) after study entry.

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

cumulative probability per 100 persons

From study entry to week 96

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Units	Counts
Participants	OG000605 OG001603 OG002601

Title

Denominators

Categories

Title	Measurements
	OG00013(10 to 16) OG00110(7 to 12) OG00215(12 to 18)

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	Treatment comparison was made using the difference (arm A - arm B) in the stratified Kaplan-Meier estimate for the week 96 cumulative probability of virologic failure with 97.5% confidence interval.					Cumulative probability difference	3.4			2-Sided	97.5	-0.7	7.4				Yes	Non-Inferiority or Equivalence	Confidence interval estimation was stratified by HIV-1 RNA level at screening using Greenwood's variance with the inverse of this variance used for the stratum weights. The pre-specified confidence bounds for equivalence were +/-10 percentage points.

Primary

Cumulative Incidence of Discontinuation of the RAL or PI Component of Randomized Treatment for Toxicity by Week 96

The cumulative incidence of discontinuation for toxicity by week 96 was estimated using competing risks with treatment discontinuation for other reasons considered as a competing event; participants completing the study on the RAL or PI component of their randomized regimen were considered censored at the earliest of the date of last patient contact and off study date.

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

cumulative events per 100 persons

From study entry to week 96

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)

Secondary

Cumulative Incidence of First Adverse Event by Week 96

The cumulative incidence of first adverse event (with and without total bilirubin and creatine kinase and measured from study entry) by week 96 was estimated using methods for competing risks. Discontinuation of randomized treatment prior to an adverse event was considered a competing event.

The time to the first of any post-entry Grade 2, 3, or 4 sign or symptom, or Grade 3 or 4 laboratory abnormality while on randomization. The protocol required reporting of signs and symptoms and laboratory values as follow: all signs and symptoms grade ≥2 post-entry to week 48, signs and symptoms grade >3 after week 48, and laboratory values grade >3 and all signs, symptoms, and laboratory values that led to a change in treatment, regardless of grade throughout out all post-entry follow-up.

As treated: Participants who had events occurring while on randomized treatment are included in this analysis: grade 2 events occurring in the after 48 weeks on study are excluded. Participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

cumulative events per 100 persons

From study entry to week 96

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001

Secondary

Cumulative Probability of Time to Loss of Virologic Response (TLOVR) by Week 96

The Kaplan-Meier estimate of the cumulative probability of TROVR by week 96.

A composite TLOVR endpoint defined in the CDER of the FDA document "Guidance for Industry - Antiretroviral Drugs Using Plasma HIV RNA Measurements - Clinical Consideration for Accelerated and Traditional Approval" (Appendix B, pages 20) http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf.

If participants never achieved a confirmed HIV-1 RNA≤200 cp/mL (on two consecutive visits) prior to death, permanent discontinuation of randomized treatment, or time of last available HIV-1 RNA evaluation, TLOVR was equal to 0; otherwise, TLOVR was the earliest time of permanent discontinuation of randomized treatment prior to study close-out period, time to confirmed levels >200 cp/mL, or time to death. If TLOVR is immediately preceded by a single missing scheduled visit or multiple consecutive missing scheduled visits, TLOVR is replaced by the first such missing visit.

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

cumulative probability per 100 persons

From study entry to week 96

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)

Secondary

Presence of Mutations Associated With NRTI Resistance

The number of participants with NRTI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Participants who met the criteria for virologic failure with successful sequencing at virologic failure

Posted

Number

participants

At the virologic failure at any time throughout the study (up to 213 weeks)

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF

Secondary

Presence of Mutations Associated With ATV/RTV or DRV/RTV Resistance

The number of participants with ATV/RTV or DRV/RTV resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Participants who met the criteria for virologic failure with successful sequencing at virologic failure

Posted

Number

participants

At the virologic failure at any time throughout the study (up to 213 weeks)

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF

Secondary

Presence of Mutations Associated With INI Resistance

The number of participants with INI resistance determined by the Stanford resistance scoring algorithm (Version 6.3). All sequencing was performed regardless of status on randomized treatment at the time of virologic failure; no sequencing was performed on subjects not meeting virologic failure.

Participants who met the criteria for virologic failure restricted to participants in the RAL group and random sample of participants in PI/RTV groups with successful sequencing at virologic failure.

Posted

Number

participants

At the virologic failure at any time throughout the study (up to 213 weeks)

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002

Secondary

CD4+ T-cell Count

The absolute levels of CD4+ T-cell counts (cells/mm3)

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment. Missing data were assumed missing completely at random.

Posted

Mean

95% Confidence Interval

cells/mm^3

At Weeks 24, 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

CD4+ T-cell Count Changes From Baseline

Change was calculated as the CD4+ T-cell count at week (24, 48, 96, and 144) minus the baseline CD4+ T-cell count

Posted

Mean

95% Confidence Interval

cells/mm^3

Study entry to weeks 24, 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Incidence of Death or AIDS Defining Events (CDC Category C)

The incidence of death or AIDS defining events (CDC category C) was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

events per 100 person-years

Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)

Secondary

Incidence of Targeted Serious Non-AIDS Defining Events (Renal Failure, Liver Disease, Serious Metabolic Disorder, and CVD)

The incidence of targeted serious non-AIDS defining events was estimated as number of incident events over total person years of follow-up. Multiple new events for a single subject were counted toward events totals in estimation of event incidence; generalized estimating equations were used to estimation of robust standard errors for the incidence.

Intention to treat: All eligible participants were included in the analysis: participants were analyzed per original assigned randomized treatment.

Posted

Number

95% Confidence Interval

events per 100 person-years

Study entry to off-study at any time throughout the study (up to 213 weeks), participant follow-up time was variable

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)

Secondary

Change in Fasting Total Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting total cholesterol at week (48, 96, and 144) minus the baseline fasting total cholesterol.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

mg/dL

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Change in Fasting HDL Cholesterol Level From Baseline

Only fasting results are included. Change was calculated as the fasting HDL cholesterol at week (48, 96, and 144) minus the baseline fasting HDL cholesterol.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

mg/dL

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Change in Fasting Triglycerides Level From Baseline

Only fasting results are included. Change was calculated as the fasting triglycerides at week (48, 96, and 144) minus the baseline fasting triglycerides.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

mg/dL

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Change in Fasting Plasma Glucose Level From Baseline

Only fasting results are included. Change was calculated as the fasting plasma glucose at week (48, 96, and 144) minus the baseline fasting plasma glucose.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

mg/dL

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Change in Framingham 10-year Risk of MI or Coronary Death From Baseline

Only risk score estimated with fasting lipid results were included. Change was calculated as the Framingham 10-year risk of MI or coronary death at week (48, 96, and 144) minus the baseline Framingham 10-year risk of MI or coronary death. Framingham 10-year risk of MI or coronary death was calculated using Hear Coronary Heart Disease (10-year risk) found at https://www.framinghamheartstudy.org/risk-functions/coronary-heart-disease/hard-10-year-risk.php.

Framingham 10-year risk of MI or coronary death was calculated according to age, laboratory values of total cholesterol and HDL cholesterol, smoking status, systolic blood pressure, and treatment for hypertension. The Framingham 10-year risk of MI or coronary death was calculated as: for males: <0 point (<1 percent risk) up to ≥17 points (≥30 percent risk); whereas for females: <9 points (<1 percent risk) up to ≥25 points (≥30 percent risk). Higher scores indicate high cardiovascular risk.

Intention to treat: All participants with fasting lipids data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

percent risk

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001

Secondary

Change in Waist Circumference From Baseline

Change was calculated as the waist circumference (based on mid-waist circumference) at week (48, 96, and 144) minus the baseline waist circumference.

Intention to treat: All participants with waist circumference data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Change in Waist:Height Ratio From Baseline

Change was calculated as the waist:height ratio at week (48, 96, and 144) minus the baseline waist:height ratio.

Intention to treat: All participants with waist circumference data were included, complete-case approach.

Posted

Mean

95% Confidence Interval

cm:cm

Study entry to weeks 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Secondary

Self-reported Adherence

Self-reported percentage of anti-HIV medications participant had taken during the last month at weeks 4, 24, 48, 96, and 144.

Intention to treat: All participants with fasting self-reported adherence data were included.

Posted

Mean

95% Confidence Interval

percentage of prescribed medication

At Weeks 4, 24, 48, 96, and 144

ID	Title	Description
OG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)
OG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)
OG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm A: ATV/RTV + FTC/TDF	Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)	139	605	565	605
EG001	Arm B: RAL + FTC/TDF	FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)	126	603	516	603
EG002	Arm C: DRV/RTV + FTC/TDF	FTC/TDF, darunavir (DRV), and RTV, orally, once daily. Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)	125	601	532	601

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Necrotising granulomatous lymphadenitis	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Angina unstable	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pericarditis	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Tachycardia	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Thyroid disorder	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Thyrotoxic crisis	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Eye disorder	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Necrotising retinitis	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Colitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Erosive oesophagitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected605 at risk EG0017 affected603 at risk EG0022 affected601 at risk
Cyst rupture	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Death	General disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Inflammation	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Influenza like illness	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0014 affected603 at risk EG0023 affected601 at risk
Ulcer	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hepatic congestion	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Anaphylactic shock	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hypersensitivity	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Immune reconstitution inflammatory syndrome	Immune system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Appendicitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected605 at risk EG0011 affected603 at risk EG0023 affected601 at risk
Appendicitis perforated	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Arthritis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Arthritis infective	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Atypical pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Bacteraemia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0006 affected605 at risk EG0015 affected603 at risk EG0025 affected601 at risk
Cryptococcosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Disseminated cytomegaloviral infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Diverticulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Ear infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Eye infection syphilitic	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Groin abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Hepatitis syphilitic	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Herpes virus infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Lobar pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Malaria	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Meningitis aseptic	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Meningitis viral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Mycobacterial infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Neurosyphilis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Osteomyelitis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pelvic abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pelvic inflammatory disease	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Pharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0008 affected605 at risk EG0016 affected603 at risk EG0028 affected601 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pneumonia cytomegaloviral	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Postoperative wound infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Proctitis herpes	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Prostatic abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pyelonephritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Secondary syphilis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Sepsis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0013 affected603 at risk EG0020 affected601 at risk
Septic shock	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Sinusitis bacterial	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Soft tissue infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Tooth abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Tubo-ovarian abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Viral infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Viral myocarditis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Laryngeal injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0013 affected603 at risk EG0020 affected601 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Blood bilirubin increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Blood cholesterol increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Blood creatinine increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Chest X-ray abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Haemoglobin decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Hepatic enzyme increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Laboratory test abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Liver function test abnormal	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0022 affected601 at risk
Neutrophil count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Staphylococcus test positive	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Transaminases increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0023 affected601 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Anal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0013 affected603 at risk EG0020 affected601 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Large cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Mucoepidermoid carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Carotid artery aneurysm	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Complex partial seizures	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Complicated migraine	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Embolic stroke	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0013 affected603 at risk EG0021 affected601 at risk
Hemiparesis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Migraine	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Status epilepticus	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Wernicke's encephalopathy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Blighted ovum	Pregnancy, puerperium and perinatal conditions	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hyperemesis gravidarum	Pregnancy, puerperium and perinatal conditions	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Acute psychosis	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Affective disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Bipolar disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Catatonia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Completed suicide	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected605 at risk EG0014 affected603 at risk EG0024 affected601 at risk
Drug abuse	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Hallucination, auditory	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Homicidal ideation	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Major depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Psychotic disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0012 affected603 at risk EG0020 affected601 at risk
Substance abuse	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0012 affected603 at risk EG0021 affected601 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0012 affected603 at risk EG0029 affected601 at risk
Suicide attempt	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected605 at risk EG0017 affected603 at risk EG0026 affected601 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0022 affected601 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0013 affected603 at risk EG0024 affected601 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected605 at risk EG0013 affected603 at risk EG0021 affected601 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected605 at risk EG0013 affected603 at risk EG0020 affected601 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0013 affected603 at risk EG0024 affected601 at risk
Mediastinal mass	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0022 affected601 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0021 affected601 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Alcohol detoxification	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Cyst removal	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hospitalisation	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Mastectomy	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0000 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Nephrectomy	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Hypertensive crisis	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0021 affected601 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected605 at risk EG0010 affected603 at risk EG0020 affected601 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ocular icterus	Eye disorders	MedDRA 17.0	Systematic Assessment	EG00040 affected605 at risk EG0011 affected603 at risk EG0020 affected601 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00035 affected605 at risk EG00123 affected603 at risk EG00232 affected601 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00031 affected605 at risk EG00125 affected603 at risk EG00223 affected601 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00061 affected605 at risk EG00145 affected603 at risk EG00267 affected601 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00061 affected605 at risk EG00143 affected603 at risk EG00259 affected601 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00042 affected605 at risk EG00129 affected603 at risk EG00240 affected601 at risk
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG00041 affected605 at risk EG00136 affected603 at risk EG00235 affected601 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG00037 affected605 at risk EG00139 affected603 at risk EG00237 affected601 at risk
Bronchitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00028 affected605 at risk EG00133 affected603 at risk EG00228 affected601 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG00036 affected605 at risk EG00128 affected603 at risk EG00229 affected601 at risk
Alanine aminotransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG00068 affected605 at risk EG00159 affected603 at risk EG00246 affected601 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG00073 affected605 at risk EG00177 affected603 at risk EG00269 affected601 at risk
Blood bilirubin increased	Investigations	MedDRA 17.0	Systematic Assessment	EG000318 affected605 at risk EG00120 affected603 at risk EG00212 affected601 at risk
Blood cholesterol increased	Investigations	MedDRA 17.0	Systematic Assessment	EG000212 affected605 at risk EG001152 affected603 at risk EG002227 affected601 at risk
Blood creatinine increased	Investigations	MedDRA 17.0	Systematic Assessment	EG000105 affected605 at risk EG00173 affected603 at risk EG00298 affected601 at risk
Blood glucose decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00065 affected605 at risk EG00189 affected603 at risk EG00282 affected601 at risk
Blood glucose increased	Investigations	MedDRA 17.0	Systematic Assessment	EG000115 affected605 at risk EG00195 affected603 at risk EG002105 affected601 at risk
Blood phosphorus decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00070 affected605 at risk EG00167 affected603 at risk EG00270 affected601 at risk
Blood sodium decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00057 affected605 at risk EG00165 affected603 at risk EG00255 affected601 at risk
Low density lipoprotein increased	Investigations	MedDRA 17.0	Systematic Assessment	EG000184 affected605 at risk EG001139 affected603 at risk EG002183 affected601 at risk
Neutrophil count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00074 affected605 at risk EG00185 affected603 at risk EG00274 affected601 at risk
Platelet count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00025 affected605 at risk EG00132 affected603 at risk EG00224 affected601 at risk
White blood cell count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG00034 affected605 at risk EG00135 affected603 at risk EG00232 affected601 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00029 affected605 at risk EG00129 affected603 at risk EG00232 affected601 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00025 affected605 at risk EG00133 affected603 at risk EG00223 affected601 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00049 affected605 at risk EG00149 affected603 at risk EG00235 affected601 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00045 affected605 at risk EG00148 affected603 at risk EG00246 affected601 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG00047 affected605 at risk EG00160 affected603 at risk EG00253 affected601 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00054 affected605 at risk EG00153 affected603 at risk EG00246 affected601 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00029 affected605 at risk EG00132 affected603 at risk EG00222 affected601 at risk

ID	Term
D015658	HIV Infections

Ancestor Terms

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
D000069480	Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
D000068898	Raltegravir Potassium
D000069454	Darunavir
D019438	Ritonavir
D000069446	Atazanavir Sulfate

Ancestor Terms

ID	Term
D000068698	Tenofovir
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D000068679	Emtricitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides
D004338	Drug Combinations
D004364	Pharmaceutical Preparations
D011760	Pyrrolidinones
D011759	Pyrrolidines
D013449	Sulfonamides
D000577	Amides
D002219	Carbamates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D013450	Sulfones
D013457	Sulfur Compounds
D005663	Furans
D013844	Thiazoles
D001393	Azoles
D011725	Pyridines
D009842	Oligopeptides
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

FTC/TDF, darunavir (DRV), and RTV, orally, once daily.

Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)