A Phase 2B Multicenter, Randomized, Comparative Trial Of... | NCT00823979

ID	Type	Description	Link
2007-004392-19	EudraCT Number

Label	Type	Intervention Names
UK- 453,061 Dose One	Experimental	Drug: UK-453,061 Dose 1
UK- 453,061 Dose Two	Experimental	Drug: UK-453,061 Dose 2
Comparator	Active Comparator	Drug: Etravirine

Name	Type	Description	Arm Group Labels	Other Names
UK-453,061 Dose 1	Drug	UK 453,061 750 mg QD + one optimized NRTI + darunavir/ritonavir.	UK- 453,061 Dose One

Measure	Description	Time Frame
Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24	Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).	Week 24

Measure	Description	Time Frame
Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96	Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).	Weeks 48, 96
Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jeffrey Goodman Special Care Clinic		Los Angeles	California	90028	United States
Office of Anthony Mills, MD, Inc.

ID	Title	Description
FG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Human Immunodeficiency Virus Type 1 Ribonucleic Acid (HIV-1 RNA) Levels Less Than (<) 50 Copies/Milliliter (mL) at Week 24

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

ITT population. Participants who died, discontinued, lost to follow-up, switched/changed dose of anti-retro viral (ARV) drug not allowed by protocol, had missing plasma HIV-1 RNA data at 24 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure.

Posted

Number

percentage of participants

Week 24

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG002	Etravirine 200 mg	Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Units	Counts
Participants	OG00031 OG00132 OG00234

Title

Denominators

Categories

Title	Measurements
	OG00048.4 OG00143.8 OG00267.6

Secondary

Percentage of Participants With HIV-1 RNA Levels <50 Copies/mL at Week 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

ITT population. Participants who died, discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 48, 96 weeks were considered to have plasma HIV-1 RNA >=50 copies/mL and were referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.

Posted

Number

percentage of participants

Weeks 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL at Week 24, 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5).

ITT population. Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24, 48, 96 weeks were considered to have plasma HIV-1 RNA >=400 copies/mL and referred to as failure. n=participants evaluable at specified time point for each arm group, respectively.

Posted

Number

percentage of participants

Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Change From Baseline in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

Plasma HIV-1 RNA level was determined by the Roche Amplicor HIV-1 Monitor standard assay (version 1.5). For the log10 scale, all the HIV-1 RNA levels were log10 transformed prior to the average calculations. Baseline value calculated as average of measurements collected prior to and including Day 1 pre-dose.

ITT population. Participant discontinued before a visit of interest: value imputed as zero; not discontinued but observation is missing: last observation carried forward (LOCF) imputation used; missing baseline or no HIV-1 RNA level assessment: value imputed as zero.

Posted

Mean

Standard Deviation

log10 copies/mL

Baseline, Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Time-Averaged Difference (TAD) in log10 Transformed HIV-1 RNA Levels at Week 24, 48 and 96

TAD was calculated as (area under the curve of HIV-1 RNA levels [log10 copies/mL] from baseline to the time point of interest divided by time period in weeks) minus baseline HIV-1 RNA level (log10 copies/mL). Baseline value calculated as average of measurements collected at prior to and including Day 1 pre-dose. Due to early termination of the study decision was made not to derive TAD results for Week 96.

ITT population. Participant discontinued before a visit of interest: TAD imputed as zero; not discontinued but observation was missing at visit: TAD to the last non-missing timepoint; not discontinued and missing values between baseline and visit: ignore missing values; missing baseline or no HIV-1 RNA level assessment: TAD imputed as zero.

Posted

Mean

Standard Deviation

log10 copies/mL

Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Percentage of Participants With Response as Determined by the Time to Loss of Virologic Response (TLOVR50) Algorithm at Week 24, 48 and 96

TLOVR50 response (50 denotes lower limit of quantification [LLOQ] of assay=50 copies/mL): compliment to TLOVR50 failure. TLOVR50 failure based on observed HIV-1 RNA levels and failure events (death; permanent discontinuation of drug; lost to follow-up; new ARV drug; met treatment failure [TF] criteria). TF: an increase of at least (>=)3 times the baseline plasma HIV-1 RNA level at Week 2 or thereafter; failure to achieve HIV-1 RNA level <50 copies/mL at Week 24; starting at Week 2, an increase in HIV-1 RNA level to detectable levels (>50 copies/mL); HIV-1 RNA <1 log10 decrease from baseline at Week 4 or thereafter. TF were confirmed by second measurement >=14 days after first. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

ITT.Participants who died,discontinued,lost to follow-up,switched/changed dose of ARV drug not allowed by protocol,had missing plasma HIV-1 RNA data at 24,48 weeks were considered to have plasma HIV-1 RNA>=50 copies/mL;were referred as failure. Due to early termination of study,decision was made not to derive TLOVR50 responder analysis for Week 96.

Posted

Number

percentage of participants

Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Change From Baseline in Cluster of Differentiation 4 (CD4+) Absolute Lymphocyte Counts at Week 24, 48 and 96

Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

ITT population included all randomized participants who received at least 1 dose of study drug. Missing values were imputed using LOCF. Participants with missing baseline or no CD4+ count available on treatment imputed as no or zero change from baseline.

Posted

Mean

Standard Deviation

cells per microliter (cells/mcL)

Baseline, Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Change From Baseline in Cluster of Differentiation 4 (CD4+) Percentage Lymphocyte Counts at Week 24, 48, 96

Blood samples for immunological status assessed by CD4+ lymphocyte count. Baseline value was calculated as the average of the measurements collected prior to and including Day 1 pre-dose.

Posted

Mean

Standard Deviation

percentage of total lymphocytes

Baseline, Week 24, 48, 96

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Number of Participants With Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) Resistance-Associated Mutations (RAMs) and/or Phenotypic Susceptibility at Time of Treatment Failure Through Week 48

Genotypic and phenotypic resistance to NNRTIs based on International Acquired Immunodeficiency Syndrome (AIDS) Society, United States of America (IAS-USA) RAM guidelines were evaluated using Monogram Biosciences PhenoSenseGT Assay at Baseline. This was then repeated for all participants with HIV-1 viral load >500 copies/mL at treatment failure, up to Week 48.

Virology analysis set included a subset of participants from TLOVR50 failures who had valid genotypic or phenotypic susceptibility testing result and with plasma HIV-1 RNA >500 copies/mL at baseline and treatment failure.

Posted

Number

participants

Baseline through Week 48

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.

Secondary

Number of Participants With Laboratory Test Abnormalities

Laboratory analysis included blood chemistry, hematology and urinalysis.

Safety analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Number

participants

Baseline up to Week 48 or early termination

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG002	Etravirine 200 mg

Secondary

Population Pharmacokinetics (PK) of Lersivirine

Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Not Posted

Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

Participants

Secondary

Lersivirine Success Percentage With Reference to Median Minimum Observed Plasma Concentration (Cmin)

Simple quartile exposure analysis of success rate (viral load <50 copies/mL) versus median Cmin assesses the exposure response relationship. Percentage of participants with HIV-1 RNA level <50 copies/mL at median Cmin quartile were planned to be reported.

Due to the sparsity of the data, the ability to interpret the pharmacokinetic/pharmacodynamic (PK/PD) results was limited, thus the data was not reported.

Posted

Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48

ID	Title	Description
OG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
OG002

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Coronary artery disease	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Palpitations	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Sinus bradycardia	Cardiac disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Ear pain	Ear and labyrinth disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Hypothyroidism	Endocrine disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Conjunctivitis	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Conjunctivitis allergic	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Uveitis	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Visual acuity reduced	Eye disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0013 affected32 at risk EG0023 affected34 at risk
Cheilitis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Constipation	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Dental caries	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0008 affected31 at risk EG0017 affected32 at risk EG0026 affected34 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0012 affected32 at risk EG0021 affected34 at risk
Faeces hard	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Flatulence	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Gastritis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Glossodynia	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Nausea	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0008 affected31 at risk EG00114 affected32 at risk EG0024 affected34 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Oral disorder	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Salivary hypersecretion	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Vomiting	Gastrointestinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0006 affected31 at risk EG0013 affected32 at risk EG0023 affected34 at risk
Asthenia	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Fat tissue increased	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Fatigue	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Gait disturbance	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Pain	General disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hypersensitivity	Immune system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Abscess neck	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Acarodermatitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Acute sinusitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Body tinea	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Bronchitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Carbuncle	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Cellulitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Cystitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Dermatophytosis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Folliculitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Furuncle	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Gastroenteritis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0022 affected34 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Gingivitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hepatitis B	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Herpes simplex	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Herpes zoster	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0025 affected34 at risk
Hordeolum	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Influenza	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0004 affected31 at risk EG0010 affected32 at risk EG0024 affected34 at risk
Labyrinthitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Myringitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Nasopharyngitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Onychomycosis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Oral hairy leukoplakia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Otitis media	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Papilloma viral infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Paronychia	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Pharyngitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Rhinitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Sinusitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Tinea cruris	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Tinea pedis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Tonsillitis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Tooth abscess	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Trichomoniasis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0003 affected31 at risk EG0013 affected32 at risk EG0025 affected34 at risk
Urinary tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0013 affected32 at risk EG0023 affected34 at risk
Vaginal infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Radiation associated pain	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Blood cholesterol increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Blood glucose increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0022 affected34 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Blood triglycerides increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hepatic enzyme abnormal	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Hepatic enzyme increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Low density lipoprotein increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Tetrahydrocortisol urine increased	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Urine leukocyte esterase positive	Investigations	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected32 at risk EG0025 affected34 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0022 affected34 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0023 affected34 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Aphasia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Burning sensation	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Convulsion	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Disturbance in attention	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Dizziness	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected32 at risk EG0021 affected34 at risk
Headache	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected32 at risk EG0024 affected34 at risk
Hemiparesis	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Hemiplegia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hypersomnia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Hypogeusia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Memory impairment	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Muscle spasticity	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0021 affected34 at risk
Paraesthesia	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Somnolence	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Vasogenic cerebral oedema	Nervous system disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Anxiety	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Depressed mood	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Depression	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0023 affected34 at risk
Insomnia	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Nightmare	Psychiatric disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Proteinuria	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Renal failure acute	Renal and urinary disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Lung cyst	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Dyshidrosis	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0020 affected34 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Intertrigo	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0020 affected34 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0012 affected32 at risk EG0021 affected34 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0025 affected34 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Scar	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0002 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0012 affected32 at risk EG0021 affected34 at risk
Arterial spasm	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Hypertension	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Hypertensive crisis	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0000 affected31 at risk EG0011 affected32 at risk EG0020 affected34 at risk
Hypotension	Vascular disorders	MedDRA v15.1	Non-systematic Assessment	EG0001 affected31 at risk EG0010 affected32 at risk EG0021 affected34 at risk

ID	Title	Description
BG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
BG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
BG002	Etravirine 200 mg	Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lersivirine 750 mg	Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.	1	31	27	31
EG001	Lersivirine 1000 mg	Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.	4	32	25	32
EG002	Etravirine 200 mg	Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.	1	34	32	34