Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Comb... | NCT04021290

Name	Class
GlaxoSmithKline	INDUSTRY
PPD Development, LP	INDUSTRY

Label	Type	Description	Intervention Names
Participants receiving DTG/3TC FDC	Experimental	Eligible participants will be randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from Day 1 up to 52 weeks. Participants who complete 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	Drug: DTG/3TC FDC
Participants receiving CAR	Active Comparator	Eligible participants will continue to receive CAR from Day 1 up to 52 weeks.	Drug: CAR

Name	Type	Description	Arm Group Labels	Other Names
DTG/3TC FDC	Drug	DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route.

Measure	Description	Time Frame
Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48	Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.	Week 48

Measure	Description	Time Frame
Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 48	Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible participants must be able to understand and comply with protocol requirements, instructions, and restrictions; participant must be likely to complete the study as planned; participants should be considered appropriate candidates for participation in an investigative clinical trial with oral medication (example given [e.g.] no active problematic substance abuse, acute major organ disease, or potential long-term work assignments out of the country).
Participant should be aged 18 years or older (or older, if required by local regulatory agencies), at the time of signing the informed consent.
Participants living with HIV.
Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
Plasma HIV-1 RNA <50 c/mL at Screening.
Participant must be on uninterrupted current regimen (either the initial or second Combination antiretroviral therapy [cART] regimen) for at least 3 months prior to Screening.

i) Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification and must not have been done for suspected or established treatment failure. The following switches, if they are the only switches, would not be considered a change in regimen. a) A switch from a PI boosted with ritonavir (RTV) to the same PI boosted with cobicistat is allowed (and vice versa). b) A switch from 3TC to emtricitabine (FTC) (and vice versa). c) A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) (and vice versa).

ii) Acceptable stable cART regimens prior to Screening include 2 NRTIs plus a) INI (either the initial or second cART regimen) b) NNRTI (either the initial or second cART regimen) c) Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen).

A male or female participant.
A female participant is eligible to participate if she is not pregnant [as confirmed by a negative serum human chorionic gonadotrophin (hCG) test at screen and a negative urine hCG test at randomization (a local serum hCG test at randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization)], not breastfeeding, and at least one of the following conditions applies; not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period from 28 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication. All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner; The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
Participant must be capable of giving signed informed consent.
Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Exclusion Criteria:

Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease except cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells per cubic millimeter (mm^3) are not exclusionary.
Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
Participants with unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Participants with the evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Participant's positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti-HBc must be either total anti-HBc or anti-HBc immunoglobulin G (IgG), and not anti-HBc Immunoglobulin M (IgM). Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a TAF/TDF regimen are excluded.
Participants with anticipated need for any hepatitis C virus (HCV) therapy during the randomized phase of the study, or anticipated need for HCV therapy with a potential for adverse drug-drug interactions with DTG or 3TC.
Participants with untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
Participants with history or presence of allergy intolerance to the study interventions or their components or drugs of their class.
Participants with ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
Participants who in the investigator's judgment, poses a significant suicidality risk.
Participants with any pre-existing physical or mental condition which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study interventions or render the participant unable to take oral medication.
Use of any regimen consisting of single or dual ART (peri-partum treatment with single dose nevirapine is allowed).
Participants with current use of stavudine, didanosine, or nelfinavir.
Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
Participants receiving treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
Participants receiving treatment with any of the following agents within 28 days of Screening like radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant.
Participants with exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP).
Any evidence of major NRTI mutation or presence of any DTG resistance-associated mutation in any available prior resistance genotype assay test result, if known.
Participants with any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid abnormalities. A single repeat test is allowed during the Screening period to verify a result.
Participants with alanine aminotransferase (ALT) >= 5 times the upper limit of normal (ULN) or ALT >= 3 times ULN and bilirubin >= 1.5 times ULN (with >35 percent direct bilirubin).
Participants with creatinine clearance of <30 mL/min/1.73m^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method. Participants with creatinine clearance between 30 to 49 mL/min/1.73 m^2 are eligible after the medical monitor has provided approval after reviewing participant's current ART regimen.
Participants with any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant'sparticipation in the study of an investigational compound.
Participants within the 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.
Participants within the 12 month window prior to Screening and after confirmed suppression to <50 c/mL, 2 or more consecutive plasma HIV-1 RNA measurements >=50 c/mL. A single plasma HIV-1 RNA measurement >50 c/mL but less than 200 c/mL, with confirmation of return to <50 c/mL is allowed.
Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA >=400 c/mL).
Participants with any drug holiday during the 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.
Participants who are currently participating in or anticipate to be selected for any other interventional study after randomization.
Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board [IRB]) who participated in any study using an investigational drug or vaccine during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study, or participate simultaneously in another clinical study.

Name	Affiliation	Role
GSK Clinical Trials	ViiV Healthcare	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Los Angeles	California	90033	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
35235656	Background	Llibre JM, Brites C, Cheng CY, Osiyemi O, Galera C, Hocqueloux L, Maggiolo F, Degen O, Taylor S, Blair E, Man C, Wynne B, Oyee J, Underwood M, Curtis L, Bontempo G, van Wyk J. Efficacy and Safety of Switching to the 2-Drug Regimen Dolutegravir/Lamivudine Versus Continuing a 3- or 4-Drug Regimen for Maintaining Virologic Suppression in Adults Living With Human Immunodeficiency Virus 1 (HIV-1): Week 48 Results From the Phase 3, Noninferiority SALSA Randomized Trial. Clin Infect Dis. 2023 Feb 18;76(4):720-729. doi: 10.1093/cid/ciac130.
39225890

ID	Title	Description
FG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 5, 2020	Apr 18, 2022

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

Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) >=50 Copies/Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Category at Week 48

Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent To Treat-Exposed (ITT-E) population included all randomized participants who received at least one dose of study medication either DTG/3TC or CAR.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts
Participants	OG000246 OG001247

Title

Denominators

Categories

Title	Measurements
	OG0001 OG0013

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						Adjusted Difference in Percent (ADP)	-0.8			2-Sided	95	-2.4	0.8			ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor [PI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and integrase inhibitor [INI]).		Non-Inferiority	Non-inferiority was be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the CMH adjusted difference in the proportion of patients with plasma HIV-1 RNA ≥ 50 c/mL between each treatment group (DTG/3TC - CAR) is less than 5%.

Secondary

Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 48

Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent To Treat-Exposed

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Plasma HIV-1 RNA >=50 c/mL as Per FDA Snapshot Category at Week 24

Number of participants with plasma HIV 1 RNA >=50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA >=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent To Treat-Exposed

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Plasma HIV-1 RNA <50 c/mL Using the FDA Snapshot Algorithm at Week 24

Number of participants with plasma HIV 1 RNA <50 c/mL were evaluated using FDA snapshot algorithm at Week 24 to demonstrate the antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 24 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA <50 c/mL were termed as subjects with virologic success. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Intent To Treat-Exposed

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Week 24

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

Posted

Median

Inter-Quartile Range

cells/cubic millimeter (cells/mm^3)

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in CD4+ Cell Count for Week 48

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+ lymphocyte count was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

Posted

Median

Inter-Quartile Range

cells/mm^3

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in CD4+/ Cluster of Differentiation 8 (CD8+) Cell Counts Ratio for Week 24

CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 24 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

Posted

Median

Inter-Quartile Range

Ratio

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in CD4+/CD8+ Cell Counts Ratio for Week 48

CD4+/CD8+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Lymphocyte subsets were collected for assessment of this outcome measure by flow cytometry. Change from Baseline in CD4+/CD8+ lymphocyte cell count ratio was assessed at Week 48 to evaluate the immune effects of DTG/3TC FDC once daily compared to continuation of CAR. Plasma samples for lymphocyte subsets were collected.

Intent To Treat-Exposed. Only those participants with data available at specified time points were analyzed.

Posted

Median

Inter-Quartile Range

Ratio

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Disease Progression Through Week 24

Participants with disease progression included incidences of HIV-associated conditions, Acquired Immuno Deficiency Syndrome (AIDS) and death. HIV-associated conditions were assessed according to the 2014 HIV infection by Centers for Disease Control and Prevention (CDC) classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

Intent To Treat-Exposed

Posted

Count of Participants

Participants

Up to Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Disease Progression Through Week 48

Participants with disease progression included incidences of HIV-associated conditions, AIDS and death. HIV-associated conditions were assessed according to the 2014 HIV infection by CDC classification system for HIV Infection in adults to evaluate the immune effects of DTG /3TC FDC once daily compared to continuation of CAR.

Intent To Treat-Exposed

Posted

Count of Participants

Participants

Up to Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts

Secondary

Number of Participants With Adverse Events (AEs) and AEs Leading to Discontinuation

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Safety population included all randomized participants who received at least 1 dose of study intervention either DTG/3TC or CAR.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts

Secondary

Number of Participants With AEs by Severity Grades

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms

Safety population

Posted

Count of Participants

Participants

Up to 52 weeks

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks

Blood samples were collected to evaluate hepatobiliary abnormalities. Number of participants with Bilirubin (BIL), Alkaline phosphatase (ALP), Alanine Aminotransferase (ALT)/combination of these with levels more than the defined hepatobiliary abnormality criteria were presented. Hepatocellular injury is defined as ([ALT/ALT ULN]/[ALP/ALP ULN]) >= 5 and ALT >=3xULN.

Safety population

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with any AE were presented and AEs were graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms.

Safety population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 52 weeks

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Any AEs and AEs by Severity Grades for Those Participants With Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

Safety Population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 52 weeks

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Safety population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 52 weeks

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts

Secondary

Number of Participants With Any AEs Leading to Discontinuation Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.

Safety population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to 52 weeks

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts

Secondary

Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of 30-49 mL/Min/1.73m^2

Safety population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Number of Participants With Hepatobiliary Abnormalities Through 52 Weeks Based on Baseline Creatinine Clearance of >=50 mL/Min/1.73m^2

Safety population. Only those participants with data available at specified time points were analyzed.

Posted

Count of Participants

Participants

Up to Week 52

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Fasting Lipids at Week 24

Lipid parameters included total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.

Safety Population. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

milligram/deciliter (mg/dL)

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts
Participants

Secondary

Change From Baseline in Fasting Lipids at Week 48

Lipid parameters included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides.

Safety Population. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

mg/dL

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts
Participants

Secondary

Number of Participants With Observed Genotypic and Phenotypic Resistance to Antiretrovirals (ARVs) for Participants Meeting Confirmed Virologic Withdrawal (CVW) Criteria

Genotypic and phenotypic testing was conducted for participants who met the CVW criteria, i.e., one assessment with HIV-1 RNA ≥200 c/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 c/mL at any point in the study.

Confirmed Virologic Withdrawal (CVW) population. No participants met the CVW criteria over 48 weeks; therefore, the genotypic and phenotypic resistance virologic analyses were not assessed.

Posted

Up to week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Health Status by HIV Treatment Satisfaction Questionnaire (TSQ) at Week 24

The HIV Treatment Satisfaction Questionnaire (HIVTSQ) is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

ITT-E. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Health Status by HIV TSQ at Week 48

The HIVTSQ is a 10-item self-reported scale that consists of a total score ranging from 0 to 60. Higher scores indicate a greater level of patient-reported satisfaction with their current therapy.

ITT-E. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Units	Counts

Secondary

Change From Baseline in Health Status by Symptom Distress Module (SDM) at Week 24

SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health).

ITT-E. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Day 1) and Week 24

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Health Status by SDM at Week 48

ITT-E. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Day 1) and Week 48

ID	Title	Description
OG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
OG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.

Secondary

Change From Baseline in Health Status by SDM in Continuation Phase

Intent To Treat-Exposed (ITT-E) Continuation Phase population included participants who received at least one dose of DTG/3TC during continuation phase. Only those participants with data available at specified time points has been analyzed.

Posted

Mean

Standard Deviation

Scores on a scale

Baseline (Day 1) and Week 76, Week 100, and Week 132

ID	Title	Description
OG000	Continuation Phase-Participants Who Received DTG/3TC FDC	Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Pneumonia bacterial	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anal abscess	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cataract	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Cellulitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Death	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Deep vein thrombosis	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastroenteritis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastrointestinal stromal tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Renal impairment	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Tracheitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG00018 events16 affected246 at risk EG00120 events17 affected247 at risk EG0023 events3 affected96 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG00011 events11 affected246 at risk EG00116 events15 affected247 at risk EG0023 events3 affected96 at risk
Weight increased	Investigations	MedDRA25.0	Systematic Assessment	EG00020 events20 affected246 at risk EG0015 events5 affected247 at risk EG0023 events3 affected96 at risk
COVID-19	Infections and infestations	MedDRA25.0	Systematic Assessment	EG00014 events14 affected246 at risk EG0018 events8 affected247 at risk EG0023 events3 affected96 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG00015 events14 affected246 at risk EG0017 events7 affected247 at risk EG0023 events3 affected96 at risk
Nasopharyngitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG00012 events11 affected246 at risk EG00110 events9 affected247 at risk EG0023 events3 affected96 at risk
Dizziness	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG00015 events13 affected246 at risk EG0017 events6 affected247 at risk EG0021 events1 affected96 at risk
Insomnia	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG00015 events14 affected246 at risk EG0014 events4 affected247 at risk EG0021 events1 affected96 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0005 events5 affected246 at risk EG00111 events10 affected247 at risk EG0022 events2 affected96 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0007 events7 affected246 at risk EG0019 events8 affected247 at risk EG0020 events0 affected96 at risk
Syphilis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG00010 events9 affected246 at risk EG0015 events5 affected247 at risk EG0021 events1 affected96 at risk
Hypertension	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0007 events6 affected246 at risk EG0017 events7 affected247 at risk EG0022 events2 affected96 at risk
Pyrexia	General disorders	MedDRA25.0	Systematic Assessment	EG0008 events6 affected246 at risk EG0017 events7 affected247 at risk EG0020 events0 affected96 at risk
Anxiety	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0005 events5 affected246 at risk EG0016 events6 affected247 at risk EG0025 events5 affected96 at risk
Fatigue	General disorders	MedDRA25.0	Systematic Assessment	EG0005 events5 affected246 at risk EG0016 events6 affected247 at risk EG0020 events0 affected96 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0017 events7 affected247 at risk EG0020 events0 affected96 at risk
Nausea	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0007 events6 affected246 at risk EG0016 events4 affected247 at risk EG0021 events1 affected96 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0017 events5 affected247 at risk EG0021 events1 affected96 at risk
Gastroenteritis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0015 events5 affected247 at risk EG0022 events2 affected96 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0016 events4 affected247 at risk EG0020 events0 affected96 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0005 events5 affected246 at risk EG0013 events3 affected247 at risk EG0021 events1 affected96 at risk
Urinary tract infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0004 events3 affected246 at risk EG0015 events5 affected247 at risk EG0023 events3 affected96 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0016 events5 affected247 at risk EG0020 events0 affected96 at risk
Constipation	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0016 events6 affected247 at risk EG0020 events0 affected96 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0014 events4 affected247 at risk EG0020 events0 affected96 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0007 events6 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Renal impairment	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Blood creatinine increased	Investigations	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0013 events3 affected247 at risk EG0025 events5 affected96 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0015 events5 affected247 at risk EG0025 events5 affected96 at risk
Low density lipoprotein increased	Investigations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0014 events4 affected247 at risk EG0024 events4 affected96 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0005 events5 affected246 at risk EG0011 events1 affected247 at risk EG0022 events2 affected96 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Sleep disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0005 events4 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0013 events2 affected247 at risk EG0021 events1 affected96 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Blood cholesterol increased	Investigations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0013 events3 affected247 at risk EG0022 events2 affected96 at risk
Conjunctivitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0005 events4 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Flatulence	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0004 events4 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Sinusitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0014 events4 affected247 at risk EG0021 events1 affected96 at risk
Toothache	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Vomiting	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Bronchitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Chest pain	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Chlamydial infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0013 events2 affected247 at risk EG0020 events0 affected96 at risk
Depression	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0014 events4 affected247 at risk EG0020 events0 affected96 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastritis	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Influenza	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0021 events1 affected96 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0003 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Onychomycosis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Otitis externa	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Pharyngitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Proctitis gonococcal	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0004 events3 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Asthenia	General disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Chest discomfort	General disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected247 at risk EG0022 events2 affected96 at risk
Dental caries	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0013 events2 affected247 at risk EG0021 events1 affected96 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Haematuria	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Herpes zoster	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Hypoaesthesia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Influenza like illness	General disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Insulin resistance	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Oropharyngeal gonococcal infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Paraesthesia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Respiratory tract infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Rhinitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Sciatica	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0013 events3 affected247 at risk EG0020 events0 affected96 at risk
Suspected COVID-19	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Vertigo	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0003 events3 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Abnormal dreams	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Aspartate aminotransferase increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Blood glucose increased	Investigations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Blood pressure increased	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events1 affected247 at risk EG0022 events2 affected96 at risk
Blood triglycerides increased	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cataract	Eye disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Cellulitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Creatinine renal clearance increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Cystitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Ear infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Ear pain	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Feeling abnormal	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Fungal skin infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Furuncle	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastrointestinal infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Glomerular filtration rate decreased	Investigations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0023 events3 affected96 at risk
Gonococcal infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gonorrhoea	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Herpes simplex	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hot flush	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Loss of libido	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Memory impairment	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Metabolic syndrome	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Oral herpes	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0003 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Pain	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Periodontitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Platelet count decreased	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Presyncope	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Primary syphilis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Proteinuria	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Sensory loss	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Subcutaneous abscess	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Suicidal ideation	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Syncope	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Tonsillitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Transaminases increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0021 events1 affected96 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Urine protein/creatinine ratio increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events2 affected247 at risk EG0020 events0 affected96 at risk
Vaccination complication	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0002 events2 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Viral infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Weight decreased	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Acarodermatitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Acromegaly	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Adjustment disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Affective disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Ageusia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Alanine aminotransferase increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Alcohol abuse	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anal chlamydia infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anal fissure	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anorectal human papilloma virus infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Anosmia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Anxiety disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Back injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Bacterial vaginosis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Bipolar disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Blood cholesterol decreased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Blood creatine increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0022 events2 affected96 at risk
Blood glucose abnormal	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Blood insulin increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Blood prolactin increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Blood urine present	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Body tinea	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Bone formation increased	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Bronchitis viral	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Burning sensation	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Candida infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Cerumen impaction	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Chills	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Chronic sinusitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Colitis	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Conjunctivitis allergic	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Creatinine renal clearance decreased	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Crystal urine present	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Cyst	General disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dental restoration failure	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Depressed mood	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Diabetes insipidus	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dry eye	Eye disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Duodenitis	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dysgeusia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dyshidrotic eczema	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dysphagia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Dysplastic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dysplastic naevus syndrome	Congenital, familial and genetic disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Dysuria	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Ear pruritus	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Essential hypertension	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Eyelid infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Fall	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Finger deformity	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Folliculitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Food allergy	Immune system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Food poisoning	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Fungal infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastric cyst	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastric dilatation	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Gastroenteritis viral	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Genital herpes	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Genital herpes simplex	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Genitourinary chlamydia infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Gingival pain	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Glaucoma	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Glucose urine present	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Glycosuria	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hemianopia heteronymous	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hemiparesis	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hepatic enzyme increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Hypersensitivity	Immune system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Hypopituitarism	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Ill-defined disorder	General disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Initial insomnia	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Laryngitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Lip swelling	Gastrointestinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Localised infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Malaise	General disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Menstruation delayed	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Migraine	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Miliaria	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Mixed anxiety and depressive disorder	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Muscle fatigue	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0021 events1 affected96 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Neck injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Nerve compression	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Neuralgia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Nightmare	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Obesity	Metabolism and nutrition disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Ocular hypertension	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Oedema peripheral	General disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Otitis media acute	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Paronychia	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pelvic organ injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Penis injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Peripheral coldness	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Peripheral swelling	General disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0013 events1 affected247 at risk EG0020 events0 affected96 at risk
Peripheral venous disease	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pharyngeal chlamydia infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Pharyngeal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Pneumonia bacterial	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pneumonia viral	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Protein urine present	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Pseudofolliculitis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Pulse absent	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Renal colic	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
SARS-CoV-2 test positive	Investigations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Seasonal allergy	Immune system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Secondary hypothyroidism	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Secondary syphilis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Sinusitis bacterial	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Skin infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Skin injury	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Skin odour abnormal	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Skin plaque	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Solar dermatitis	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Solar lentigo	Skin and subcutaneous tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Stress	Psychiatric disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Stress at work	Social circumstances	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Tendon pain	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Thyroid disorder	Endocrine disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tinea capitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tinea infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Tinea pedis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tooth infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tracheitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Tremor	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Urethritis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Urethritis gonococcal	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Urine albumin/creatinine ratio increased	Investigations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0011 events1 affected247 at risk EG0020 events0 affected96 at risk
Urine odour abnormal	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA25.0	Systematic Assessment	EG0002 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Vasodilatation	Vascular disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Vision blurred	Eye disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0012 events1 affected247 at risk EG0020 events0 affected96 at risk
Visual acuity reduced	Eye disorders	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0020 events0 affected96 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0001 events1 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Bell's palsy	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Labyrinthitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Lymph gland infection	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Orchitis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Bladder pain	Renal and urinary disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk
Device physical property issue	Product Issues	MedDRA25.0	Systematic Assessment	EG0000 events0 affected246 at risk EG0010 events0 affected247 at risk EG0021 events1 affected96 at risk

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

ID	Term
D018986	Motor Vehicles
D014186	Transportation
D013676	Technology, Industry, and Agriculture

ID	Title	Description
BG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.
BG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Randomized Phase-Participants Who Received DTG/3TC FDC	Eligible participants were randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from day 1 up to 52 weeks. Participants who completed 52 weeks of treatment had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase.	1	246	7	246	179	246
EG001	Randomized Phase-Participants Who Received CAR	Eligible participants received CAR from day 1 up to 52 weeks. CAR included 2 nucleoside reverse transcriptase inhibitors (NTRIs) plus either an integrase inhibitor (INI), non-nucleoside reverse transcriptase inhibitor (NNRTI), or boosted protease inhibitor (PI) or atazanavir unboosted.	0	247	16	247	169	247
EG002	Continuation Phase-Participants Who Received DTG/3TC FDC	Participants who completed 52 weeks of treatment of DTG/3TC FDC had the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase up to week 132.	0	96	1	96	43	96