A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 In... | NCT00951015 | Trialant
NCT00951015
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Jan 16, 2018Actual
Enrollment
208Actual
Phase
Phase 2
Conditions
Infection, Human Immunodeficiency Virus
Interventions
GSK1349572
efavirenz
Countries
United States
France
Germany
Italy
Russia
Spain
Protocol Section
Identification Module
NCT ID
NCT00951015
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
112276
Secondary IDs
Not provided
Brief Title
A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects
Official Title
A Phase IIb Study to Select a Once Daily Dose of GSK1349572 Administered With Either Abacavir/Lamivudine or Tenofovir/Emtricitabine in HIV-1 Infected Antiretroviral Therapy Naive Adult Subjects
Acronym
ING112276
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Apr 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 30, 2009
Primary Completion Date
Feb 26, 2010Actual
Completion Date
Dec 22, 2016Actual
First Submitted Date
Jul 30, 2009
First Submission Date that Met QC Criteria
Jul 30, 2009
First Posted Date
Aug 3, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 22, 2013
Results First Submitted that Met QC Criteria
Aug 22, 2013
Results First Posted Date
Nov 11, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 17, 2011
Certification/Extension First Submitted that Passed QC Review
Mar 17, 2011
Certification/Extension First Posted Date
Mar 28, 2011Estimated
Last Update Submitted Date
Dec 14, 2017
Last Update Posted Date
Jan 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
Shionogi
INDUSTRY
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This Phase IIb study in HIV-infected antiretroviral naive subjects will select an optimal once daily dose of GSK1349572 from a range of doses for future evaluation.
Detailed Description
This Phase IIb study in HIV-infected antiretroviral naive adult subjects will include a dose-ranging evaluation of GSK1349572 10mg, 25mg and 50mg once daily blinded doses and a control arm of open label efavirenz 600mg once daily. Background ART for all study subjects will be chosen by the investigators and will be either Truvada or Epzicom/Kivexa. Data from the three doses of GSK1349572 will be compared on the basis of antiviral activity, safety/tolerability and pharmacokinetics over 16-24 weeks.
Several planned interim analyses will evaluate data in real time; any doses considered inferior will be dropped and subjects on those doses of GSK1349572 will have the option to switch to either the highest dose still under investigation or the selected dose. Subjects will be able to remain in the study, unless they reach a stopping criterion, for at least 96 weeks.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
Keywords
GSK1349572
emtricitabine
tenofovir
efavirenz
abacavir
antiretroviral therapy naive
dose selection
HIV-1 Infection
integrase inhibitor
HIV infection
once daily
lamivudine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
208Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
10 mg GSK1349572
Experimental
subjects will receive GSK1349572 10mg once daily blinded to dose
Drug: GSK1349572
25mg GSK1349572
Experimental
subjects will receive GSK1349572 25mg once daily blinded to dose
Drug: GSK1349572
50mg GSK1349572
Experimental
subjects will receive GSK1349572 50mg once daily blinded to dose
Drug: GSK1349572
efavirenz control
Other
efavirenz will serve as the internal control arm
Drug: efavirenz
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GSK1349572
Drug
investigational HIV-1 integrase inhibitor
10 mg GSK1349572
25mg GSK1349572
50mg GSK1349572
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Viral Change Over the Initial 2 Weeks of Treatment
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.
Baseline and Week 2
Other Outcomes
Measure
Description
Time Frame
Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points
Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.
HIV-1 infected male or female adults at least 18 years of age. Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol);
HIV-1 infection with a screening plasma HIV-1 RNA greater than or equal to 1000copies/mL;
CD4+ cell count greater than or equal to 200cells/mm3 (or higher as local guidelines dictate);
ART-naive (less than or equal to 10 days of prior therapy with any antiretroviral agent). Any previous exposure to an HIV integrase inhibitor other than GSK1349572 will be exclusionary.
No evidence of viral resistance to any antiretroviral drug indicative of primary transmitted resistance at screening;
Able to understand and comply with protocol requirements;
Able to provide written informed consent prior to screening;
French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Note: Subjects starting abacavir as part of the NRTI backbone must have been screened and be negative for the HLA-B*5701 allele.
Exclusion Criteria:
Any pre-existing or serious mental or physical disorder which could compromise ability to comply with the protocol or compromise subject safety;
Women who are pregnant or breastfeeding;
An active AIDS-defining condition at the screening visit;
Previous participation in an experimental drug and/or vaccine trial(s) within 30 days or 5 half-lives;
History of clinically relevant pancreatitis or hepatitis within the previous 6 months, including HBsAg positive result. Asymptomatic HCV infection will not be exclusionary, however subject who will require HCV therapy during the trial should be excluded. Any subject with a history of liver cirrhosis with or without hepatitis viral co-infection will be excluded.
Any condition which could interfere with the absorption, distribution, metabolism or excretion of the drug;
Any acute or Grade 4 laboratory abnormality at screening;
History of upper gastrointestinal bleed and/or subjects with active peptic ulcer disease;
Estimated creatinine clearance <50 mL/min;
Alanine aminotransferase (ALT) greater than or equal to 5 times ULN;
Alanine aminotransferase (ALT) greater than or equal to 3xULN and bilirubin greater than or equal to 1.5xULN (with >35% direct bilirubin);
Lipase greater than or equal to 3xULN;
Hemoglobin < 100 g/L(10 g/dL);
History of allergy to the study drugs or their components or drugs of their class;
Treatment with radiation therapy, cytotoxic chemotherapeutic agents, any agents with activity against HIV-1 or immunomodulators within 28 days prior to screening;
Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to screening;
History of protocol-defined cardiac diseases;
Personal or family history of prolonged QT syndrome;
Any clinically significant finding, as specified in the protocol, on electrocardiograph (ECG);
Significant blood loss in excess of 500 mL within a 56 day period prior to screening visit;
Immunization within 30 days prior to first dose of investigational product;
French subjects: The subject has participated in any study using an investigational drug 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 the subject will participate simultaneously in another clinical study.
van Lunzen J, Maggiolo F, Arribas JR, Rakhmanova A, Yeni P, Young B, Rockstroh JK, Almond S, Song I, Brothers C, Min S. Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial. Lancet Infect Dis. 2012 Feb;12(2):111-8. doi: 10.1016/S1473-3099(11)70290-0. Epub 2011 Oct 20.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 278 par were screened of which 70 were screen failures and 208 were randomized; 205 received at least one dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population. 17 participants out of 155 from DTG arm withdrew during Randomization phase and total 138 participants were enrolled in an Open-label phase.
Recruitment Details
Randomization Phase participants received Dolutegravir (DTG 10, 25 or 50 milligrams[mg]) with Placebo/Efavirenz (EFV) for 96 Weeks . DTG participants who completed 96 Weeks continued or were switched to receive DTG 50 mg in Open label phase until DTG was locally available.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and Abacavir/lamivudine (ABC/3TC) 600 mg/300 mg or tenofovir/emtricitabine (TDF/FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
approved therapy for HIV-1 infection, used as an internal study control
efavirenz control
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
Number of Participants With New HIV-associated Conditions of the Indicated Class
HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.
From Baseline up to Week 96
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.
From Baseline up to Week 96
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.
From Baseline up to Week 96/Early Withdrawal
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
From Baseline up to Week 96/Early Withdrawal
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.
From Baseline up to Week 96/Early Withdrawal
Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
From Baseline up to Week 96/Early Withdrawal
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data
From Baseline up to Week 96/Early Withdrawal
Plasma DTG Concentration
Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
Week 2, Week 12, and Week 24
AUC(0-tau) of DTG
The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG
The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
Pre-dose Concentration (C0) and C0 Avg of DTG
The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
Week 2, Week 12, and Week 24
Time to Maximal Drug Concentration (Tmax) of DTG
Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures
Week 2
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
Week 96
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.
Week 96
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles
Week 96
Bakersfield
California
93301
United States
GSK Investigational Site
Long Beach
California
90813
United States
GSK Investigational Site
San Francisco
California
94115
United States
GSK Investigational Site
Denver
Colorado
80209
United States
GSK Investigational Site
Washington D.C.
District of Columbia
20037
United States
GSK Investigational Site
Fort Lauderdale
Florida
33306
United States
GSK Investigational Site
Fort Lauderdale
Florida
33308
United States
GSK Investigational Site
Fort Lauderdale
Florida
33316
United States
GSK Investigational Site
Orlando
Florida
32804
United States
GSK Investigational Site
Santa Fe
New Mexico
87505
United States
GSK Investigational Site
Charlotte
North Carolina
28209
United States
GSK Investigational Site
Dallas
Texas
75246
United States
GSK Investigational Site
Lyon
69317
France
GSK Investigational Site
Montpellier
34295
France
GSK Investigational Site
Nantes
44093
France
GSK Investigational Site
Paris
75018
France
GSK Investigational Site
Paris
75475
France
GSK Investigational Site
Paris
75651
France
GSK Investigational Site
Frankfurt am Main
Hesse
60311
Germany
GSK Investigational Site
Hanover
Lower Saxony
30625
Germany
GSK Investigational Site
Hamburg
20146
Germany
GSK Investigational Site
Hamburg
20246
Germany
GSK Investigational Site
Bergamo
Lombardy
24127
Italy
GSK Investigational Site
Brescia
Lombardy
25123
Italy
GSK Investigational Site
Milan
Lombardy
20127
Italy
GSK Investigational Site
Milan
Lombardy
20157
Italy
GSK Investigational Site
Saint Petersburg
190103
Russia
GSK Investigational Site
Saint Petersburg
196645
Russia
GSK Investigational Site
Smolensk
214006
Russia
GSK Investigational Site
Badalona
08916
Spain
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
Madrid
28034
Spain
GSK Investigational Site
Madrid
28041
Spain
GSK Investigational Site
Madrid
28046
Spain
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
FG002
DTG 50 mg QD
Participants received DTG 50 mg matching placebo and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
FG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
FG004
Open-label DTG 50 mg QD
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
FG00053 subjects
FG00151 subjects
FG00251 subjects
FG00350 subjects
FG0040 subjects
COMPLETED
FG00048 subjects
FG00144 subjects
FG00246 subjects
FG00340 subjects
FG0040 subjects
NOT COMPLETED
FG0005 subjects
FG0017 subjects
FG0025 subjects
FG00310 subjects
FG0040 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0035 subjects
FG0040 subjects
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
Protocol-Defined Stopping Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0013 subjects
FG0021 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG004
Open-label Phase
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004138 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
DTG 10 mg QD
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
BG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
BG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
BG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00053
BG00151
BG00251
BG00350
BG004205
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00034.2± 9.25
BG00137.0± 9.79
BG00237.0± 8.89
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG0015
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
African American/African Heritage (HER)
Title
Measurements
BG0007
BG0016
BG002
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 Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16
Plasma samples were collected for quantitative HIV-1 RNA analysis at Week 16. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason. Data are reported per the Week 16 report. In later cuts of the data, the Week 16 values may have changed (because of the nature of the TLOVR algorithm).ITT-E Population included all randomized participants who received at least one dose of study medication
ITT-E Population
Posted
Number
participants
Week 16
ID
Title
Description
OG000
DTG 10 mg QD
Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (QD) for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG003
Title
Denominators
Categories
Title
Measurements
OG00051
OG00147
OG00246
OG003
Secondary
Viral Change Over the Initial 2 Weeks of Treatment
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline and Week 2. Viral change is defined as the change in plasma HIV-1 RNA over the initial 2 weeks of treatment, calculated as the value at Week 2 minus the value at Baseline. Only those participants available at the specified time point were analyzed.
ITT-E Population.
Posted
Mean
Standard Deviation
Log10 c/mL
Baseline and Week 2
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Change From Baseline in HIV-1 RNA at the Indicated Time Points
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.
ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Secondary
Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points
Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT-E Population.
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Secondary
Number of Participants With New HIV-associated Conditions of the Indicated Class
HIV-associated conditions were assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the acquired immunodeficiency syndrome (AIDS) surveillance case definition.
ITT-E Population
Posted
Number
Participants
From Baseline up to Week 96
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Secondary
Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)
Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CAT A at Baseline (BS) to CAT B event (EV), CAT A at BS to a CAT C EV; CAT B at BS to a CAT C EV; CAT C at BS to a new CAT C EV; or CAT A, B, or C at BS to death.
ITT-E Population
Posted
Number
Participants
From Baseline up to Week 96
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Number of Participants With Plasma HIV-1 RNA <50 c/mL
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<50 copies/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Number of Participants With Plasma HIV-1 RNA <400 c/mL
Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96. The analysis was performed using the time to loss of virological response (TLOVR) dataset. In the TLOVR dataset, participant responses at a specified threshold of HIV-1 RNA (<400 c/mL) are determined by using the Food and Drug Administration's TLOVR algorithm. Using the TLOVR algorithm, participants are considered to have failed on therapy if they never achieved confirmed RNA levels below the threshold, if they had confirmed rebound of RNA above the threshold, if they made a non-permitted change in background regimen, or if they permanently discontinued investigational product for any reason.
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)
An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity; or is a congenital anomaly/birth defect. All clinically suspected cases of hypersensitivity reaction to abacavir in participants receiving abacavir/lamivudine were reported as SAEs. Medical or scientific judgment was to have been exercised in other situations. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold >=3%) and SAEs.
Safety Population:All participants who received at least one dose of the study medication
Posted
Number
Participants
From Baseline up to Week 96/Early Withdrawal
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities
Blood samples were collected for the measurement of clinical chemistry and hematology parameters. Toxicities were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).
Safety Population
Posted
Number
Participants
From Baseline up to Week 96/Early Withdrawal
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Secondary
Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Genotypic Resistance Population: all participants in the ITT-E Population with available on-treatment genotypic data, excluding participants who were not protocol-defined virologic failures.
On-treatment Genotypic Resistance Population.
Posted
Number
Participants
From Baseline up to Week 96/Early Withdrawal
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Secondary
Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance
For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.
On-treatment Genotypic Resistance Population
Posted
Number
Participants
From Baseline up to Week 96/Early Withdrawal
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
Secondary
Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance
The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. Fold increase in DTG FC at the time of PDVF was derived as the PDVF FC/Baseline FC ratio. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of <1 log10 copies/mL by Week 4, with subsequent confirmation, unless plasma HIV-1 RNA is <400 copies/mL; confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 without evidence of prior suppression to <400copies/mL or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to >=400 copies/mL after prior confirmed suppression to <400 copies/mL; confirmed plasma HIV-1 RNA levels >0.5 log10 copies/mL above the nadir value, where nadir is the lowest HIV-1 value >=400 copies/mL.On-treatment Phenotypic Resistance Population: all participants in the ITT-E Population with available on-treatment phenotypic data
On-treatment Phenotypic Resistance Population
Posted
Number
Participants
From Baseline up to Week 96/Early Withdrawal
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Secondary
Plasma DTG Concentration
Blood samples for the determination of plasma DTG concentration were collected from the participants randomized to receive DTG, at the following time points: pre-dose and 2-4 hours post-dose at Weeks 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. The Pharmacokinetic (PK) Summary Population is comprised of all participants who received DTG and underwent intensive PK sampling or limited PK sampling during the study and provided evaluable DTG PK parameters. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles).Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
PK Summary Population.
Posted
Mean
Standard Deviation
Micrograms per milliliter (µg/mL)
Week 2, Week 12, and Week 24
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Secondary
AUC(0-tau) of DTG
The area under the time concentration curve over the dosing interval (AUC[0-tau]) of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed.
PK Summary Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours*µg/mL
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
Secondary
Maximal Concentration (Cmax), Minimal Concentration (Cmin), and Concentration at the End of Dosing Interval (Ctau) of DTG
The Cmax, Cmax, and Ctau of DTG were determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
PK Summary Population. Only those participants available at the specified time points were analyzed.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
ID
Title
Description
OG000
DTG 10 mg OD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
OG001
DTG 25 mg OD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
OG002
DTG 50 mg OD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
Secondary
Pre-dose Concentration (C0) and C0 Avg of DTG
The plasma DTG C0 of DTG was determined using limited/sparse PK sampling at Week 2, Week 12, and Week 24. C0 avg was calculated at Week 24 as the mean of the C0 of DTG at Week 2, Week 12, and Week 24. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Only those participants available at the specified time points were analyzed (represented by n=X, X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Summary Population.
PK Summary Population.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram per milliliter (µg/mL)
Week 2, Week 12, and Week 24
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG002
DTG 50 mg QD
Secondary
Time to Maximal Drug Concentration (Tmax) of DTG
Tmax of DTG was determined using non-compartmental analysis based on intensive PK sampling at the following time points: pre-dose; 2, 3, 4, 8, and 24 hours post-dose at Week 2. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.
PK Summary Population. Only those participants available at the specified time points were analyzed.
Posted
Median
Full Range
Hours
Pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Secondary
Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters
Relationships between Week 2 plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in plasma HIV-1 RNA at Week 2 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between plasma HIV-1 RNA and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. PK/Pharmacodynamic (PD) Analysis Population: all participants with available PD measures (e.g., safety and/or efficacy data) and with evaluable DTG plasma concentration data considered suitable for investigation of relationship with the PD measures
PK/PD Analysis Population.Only those participants available at the specified time points were analyzed.
Posted
Number
Pearson's correlation coefficient
Week 2
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Secondary
Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters
Relationships between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], C0avg [average pre-dose concentration], and Ctau [concentration at the end of the dosing interval]) and the change from Baseline in CD4+ cell counts at Week 96 (calculated as the post-Baseline value minus the value at Baseline) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between CD4+ cell counts and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association.Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed.Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
PK/PD Analysis Population.
Posted
Number
Pearson's correlation coefficient
Week 96
ID
Title
Description
OG000
DTG 10 mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Secondary
Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters
Relationships between log-transformed plasma DTG PK parameters (AUC[0-tau], Cmax, C0, C0avg, Ctau, and Cmin) and safety parameters (AE occurrence, maximum AE intensity, alanine aminotransferase [ALT], change from Baseline [CFB] in ALT, total bilirubin, CFB in total bilirubin, creatine kinase, CFB in creatine kinase, triglycerides, CFB in triglycerides, lipase, CFB in lipase, total cholesterol [TC], CFB in TC) was assessed using Pearson's correlation analyses. The Pearson's correlation coefficient is a measure of the correlation between safety parameters and plasma DTG PK parameters and ranges from -1 to 1. A value of 0 indicates no statistical association; a value close to -1 or 1 indicates a higher association. The presence of >=1 AE was used for AE occurrence. The most severe AE grade/intensity was used for maximum AE intensity. Maximum laboratory values per participant were used for safety parameters. CFB was calculated as the post-Baseline value minus the value at Baseline.
PK/PD Analysis Population.Only those participants available at the specified time points were analyzed
Posted
Number
Pearson's correlation coefficient
Week 96
ID
Title
Description
OG000
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
Units
Counts
Secondary
Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters
Logistic regressions were performed to examine the correlation between plasma DTG PK parameters (AUC[0-tau] [area under the time concentration curve over the dosing interval], Cmax [maximal concentration], Ctau [concentration at the end of the dosing interval], and C0avg [average pre-dose concentration]) on log scales and the presence of gastrointestinal system organ class AEs (abdominal pain, diarrhea, nausea, and vomiting) at Week 96. Data are presented as estimates from logistic regression, which is a measure of the association between AEs of special interest and plasma DTG PK parameters. A value of 0 indicates no statistical association; a large absolute value of the estimate indicates higher association. Because PK was assessed for DTG, no participants in the EFV treatment group were analyzed. Results are presented for participants in any DTG group (overall DTG).Only those participants available at the specified time points were analyzed represented by n=X in the category titles
PK/PD Analysis Population.
Posted
Number
estimated effect
Week 96
ID
Title
Description
OG000
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
Units
Counts
Other Pre-specified
Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points
Change from Baseline in CD8+ cell count data are not available; CD8+ data are only listed on a per-participant basis and were not summarized.
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG001
DTG 25 mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Time Frame
Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to end of study.
Description
SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
DTG 10mg QD
Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
2
53
6
53
49
53
EG001
DTG 25mg QD
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
0
51
4
51
46
51
EG002
DTG 50mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
0
51
7
51
45
51
EG003
EFV 600mg
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
0
50
7
50
46
50
EG004
Open-label DTG 50 mg QD
All DTG participants were switched to or continued DTG 50 mg with either ABC/3TC orally at 600 mg/300 mg (1 tablet) or TDF/FTC orally QD during the Open label phase
2
138
16
138
112
138
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Device malfunction
Product Issues
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG0031 events1 affected50 at risk
EG0041 events1 affected138 at risk
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Burkitt's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lipomatosis
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Mallory-Weiss syndrome
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Meningitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pneumococcal sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Primary syphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00010 events7 affected53 at risk
EG00110 events7 affected51 at risk
EG00210 events6 affected51 at risk
EG0037 events5 affected50 at risk
EG004
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 events6 affected53 at risk
EG00110 events9 affected51 at risk
EG0028 events7 affected51 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG00010 events10 affected53 at risk
EG0019 events8 affected51 at risk
EG0026 events6 affected51 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0009 events7 affected53 at risk
EG00110 events6 affected51 at risk
EG00212 events8 affected51 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 events5 affected53 at risk
EG0014 events4 affected51 at risk
EG0028 events6 affected51 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 events5 affected53 at risk
EG0013 events2 affected51 at risk
EG0023 events2 affected51 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0017 events7 affected51 at risk
EG0026 events6 affected51 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0005 events5 affected53 at risk
EG0016 events5 affected51 at risk
EG0024 events4 affected51 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0016 events6 affected51 at risk
EG0023 events2 affected51 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 events3 affected53 at risk
EG0012 events2 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0014 events3 affected51 at risk
EG0023 events3 affected51 at risk
EG003
Syphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events3 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0005 events5 affected53 at risk
EG0014 events4 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0006 events4 affected53 at risk
EG0012 events1 affected51 at risk
EG0023 events2 affected51 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0014 events3 affected51 at risk
EG0028 events6 affected51 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0006 events5 affected53 at risk
EG0013 events3 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0017 events4 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected53 at risk
EG0013 events2 affected51 at risk
EG0024 events3 affected51 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0012 events2 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events3 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0010 events0 affected51 at risk
EG0023 events3 affected51 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0013 events3 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Asthenia
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected53 at risk
EG0013 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events2 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0005 events4 affected53 at risk
EG0013 events3 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00010 events3 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected53 at risk
EG0013 events3 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0012 events2 affected51 at risk
EG0023 events3 affected51 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 events3 affected53 at risk
EG0014 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0012 events2 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0012 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0013 events3 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hypertension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0012 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0013 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events3 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0004 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0013 events3 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0015 events4 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Proctitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Acarodermatitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0013 events3 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Ear infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Faeces soft
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Furuncle
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0023 events2 affected51 at risk
EG003
Gonorrhoea
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Malaise
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Nightmare
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Otitis media
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 events3 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Stress
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urethritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Herpes virus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Hypertransaminasaemia
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Melanocytic naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events1 affected51 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Acute stress disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Amoebic dysentery
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Angular cheilitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anogenital dysplasia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0004 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Blood glucose increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Body tinea
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cystitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Dermatophytosis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Facet joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0013 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0012 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Genital herpes
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Genital lesion
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Giardiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0014 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperinsulinaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events2 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lipase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Loss of libido
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Papilloma viral infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Poor quality sleep
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Prurigo
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0022 events2 affected51 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Shigella infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Skin hyperpigmentation
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Superinfection bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Syncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Acute hepatitis C
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Adverse drug reaction
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Affect lability
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ageusia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Allergy to arthropod sting
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Amylase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0012 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Anal pap smear abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal skin tags
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal sphincter hypertonia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ankle impingement
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anorectal disorder
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anorectal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anorectal ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anosmia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Anxiety disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Aortic arteriosclerosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Arterial fibrosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Asthmatic crisis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Astigmatism
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bacterial test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Breast discomfort
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bronchopneumopathy
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Bulimia nervosa
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Candida infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Cardiac murmur
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cerumen impaction
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Chalazion
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Change of bowel habit
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Cholestasis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chondropathy
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Chronic kidney disease
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Cluster headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dark circles under eyes
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Drug intolerance
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Ear congestion
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Electrocardiogram repolarisation abnormality
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Endometritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Enterocolitis viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Epididymitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
External ear cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Face injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fat redistribution
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Febrile infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Feeling drunk
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Feeling hot
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Food allergy
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastritis viral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastroenteritis shigella
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gastrointestinal disorder
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
General physical health deterioration
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Genital herpes simplex
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Genital infection fungal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Genitourinary chlamydia infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Goitre
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Gynaecomastia
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hallucination
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hand dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Helicobacter infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hot flush
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypertonia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyperventilation
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hypoaesthesia oral
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Impetigo
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Infected naevus
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Injection site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Intestinal polyp
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Joint abscess
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Leukoplakia oral
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Libido increased
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lipoatrophy
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Listless
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Liver function test increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lower respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Lymphogranuloma venereum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Micturition urgency
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Migraine
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Multiple allergies
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Myopia
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Myosclerosis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neurosyphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Nodule
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Oedema
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pancreatic atrophy
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Paronychia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Patellofemoral pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Penile discharge
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Perianal erythema
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Periodontitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Peripheral coldness
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Peyronie's disease
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pharyngeal disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Phlebitis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pilonidal cyst
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Presbyacusis
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Primary syphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Proctitis gonococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Prostatic adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Pulpitis dental
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rectal polyp
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Rubella
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Scrotal haematoma
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Secondary syphilis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Skin candida
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Skin erosion
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Snoring
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Solar dermatitis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Stress fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Substance use disorder
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tinea cruris
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tinea infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tongue biting
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Tongue discolouration
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Tongue disorder
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Toxocariasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Trigeminal neuralgia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urethral discharge
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urethritis gonococcal
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urethritis noninfective
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Urinary hesitation
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urinary sediment present
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vaccination complication
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vision blurred
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Visual field defect
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0021 events1 affected51 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0011 events1 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Weight increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected53 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected51 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
ViiV Healthcare
866-435-7343
ID
Term
D007239
Infections
D000163
Acquired Immunodeficiency Syndrome
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012897
Slow Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C562325
dolutegravir
C098320
efavirenz
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
0 subjects
0 subjects
88 subjects
50 subjects
0 subjects
FG0043 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00412 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00412 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00414 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0048 subjects
40.7
± 11.19
BG00437.2± 10.00
6
BG0036
BG00428
Male
BG00042
BG00146
BG00245
BG00344
BG004177
8
BG0034
BG00425
American Indian or Alaska Native
Title
Measurements
BG0001
BG0013
BG0024
BG0032
BG00410
Japanese/East Asian HER/South East Asian HER
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0041
Native Hawaiian or other Pacific Islander
Title
Measurements
BG0003
BG0010
BG0020
BG0030
BG0043
White
Title
Measurements
BG00041
BG00142
BG00238
BG00343
BG004164
African American/African HER & White
Title
Measurements
BG0000
BG0010
BG0021
BG0030
BG0041
Asian & White
Title
Measurements
BG0001
BG0010
BG0020
BG0030
BG0041
50
29
Units
Counts
Participants
OG00053
OG00150
OG00250
OG00348
Title
Denominators
Categories
Title
Measurements
OG000-2.387± 0.4595
OG001-2.365± 0.5458
OG002-2.392± 0.4241
OG003-1.930± 0.4312
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Week 1, n=53, 50, 48, 50
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG000-1.815± 0.3999
OG001-1.773± 0.4650
OG002-1.738± 0.3840
OG003
Week 2, n=53, 50, 50, 48
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00348
Week 4, n=53, 50, 50, 45
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00345
Week 8, n=52, 50, 49, 45
ParticipantsOG00052
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00345
Week 12, n=53, 49, 49, 45
ParticipantsOG00053
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00345
Week 16, n=52, 49, 49, 45
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00345
Week 20, n=52, 48, 49, 44
ParticipantsOG00052
ParticipantsOG00148
ParticipantsOG00249
ParticipantsOG00344
Week 24, n=52, 49, 48, 45
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00248
ParticipantsOG00345
Week 32, n=52, 49, 47, 45
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00345
Week 40, n=51, 48, 47, 44
ParticipantsOG00051
ParticipantsOG00148
ParticipantsOG00247
ParticipantsOG00344
Week 48, n=51, 48, 48, 45
ParticipantsOG00051
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00345
Week 60, n=50, 48, 48, 44
ParticipantsOG00050
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00344
Week 72, n=51, 47, 48, 44
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG00344
Week 84, n=51, 47, 47, 43
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00343
Week 96, n=48, 44, 46, 39
ParticipantsOG00048
ParticipantsOG00144
ParticipantsOG00246
ParticipantsOG00339
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Week 1, n=53, 50, 48, 50
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00248
ParticipantsOG00350
Title
Measurements
OG00085.0(18.0 to 134.0)
OG00194.5(40.0 to 160.0)
OG00275.5(18.5 to 129.5)
OG003
Week 2, n=53, 50, 50, 47
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00347
Week 4, n=53, 50, 50, 45
ParticipantsOG00053
ParticipantsOG00150
ParticipantsOG00250
ParticipantsOG00345
Week 8, n=52, 50, 49, 44
ParticipantsOG00052
ParticipantsOG00150
ParticipantsOG00249
ParticipantsOG00344
Week 12, n=53, 48, 48, 45
ParticipantsOG00053
ParticipantsOG00148
ParticipantsOG00248
ParticipantsOG00345
Week 16, n=52, 49, 49, 44
ParticipantsOG00052
ParticipantsOG00149
ParticipantsOG00249
ParticipantsOG00344
Week 20, n=52, 48, 49, 44
ParticipantsOG00052
ParticipantsOG00148
ParticipantsOG00249
ParticipantsOG00344
Week 24, n=51, 49, 47, 44
ParticipantsOG00051
ParticipantsOG00149
ParticipantsOG00247
ParticipantsOG00344
Week 32, n=50, 48, 47, 44
ParticipantsOG00050
ParticipantsOG00148
ParticipantsOG00247
ParticipantsOG00344
Week 40, n=50, 48, 47, 44
ParticipantsOG00050
ParticipantsOG00148
ParticipantsOG00247
ParticipantsOG00344
Week 48, n=51, 47, 47, 45
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00247
ParticipantsOG00345
Week 60, n=51, 48, 47, 43
ParticipantsOG00051
ParticipantsOG00148
ParticipantsOG00247
ParticipantsOG00343
Week 72, n=51, 47, 48, 44
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00248
ParticipantsOG00344
Week 84, n=51, 47, 46, 42
ParticipantsOG00051
ParticipantsOG00147
ParticipantsOG00246
ParticipantsOG00342
Week 96, n=48, 44, 46, 39
ParticipantsOG00048
ParticipantsOG00144
ParticipantsOG00246
ParticipantsOG00339
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Category B
Title
Measurements
OG0002
OG0010
OG0021
OG0031
Category C
Title
Measurements
OG0000
OG0010
OG0021
OG003
Death
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
CAT A at Baseline to a CAT C event
Title
Measurements
OG0000
OG0010
OG0020
OG0030
CAT B at Baseline to a CAT C event
Title
Measurements
OG0000
OG0010
OG0021
OG003
CAT C at Baseline to a new CAT C event
Title
Measurements
OG0000
OG0010
OG0020
OG003
CAT A, B, or C at Baseline to death
Title
Measurements
OG0001
OG0010
OG0020
OG003
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Week 1
Title
Measurements
OG0006
OG0014
OG0024
OG003
Week 2
Title
Measurements
OG00022
OG00119
OG00211
OG003
Week 4
Title
Measurements
OG00037
OG00135
OG00231
OG003
Week 8
Title
Measurements
OG00046
OG00145
OG00243
OG003
Week 12
Title
Measurements
OG00050
OG00146
OG00245
OG003
Week 16
Title
Measurements
OG00051
OG00146
OG00247
OG003
Week 20
Title
Measurements
OG00051
OG00147
OG00247
OG003
Week 24
Title
Measurements
OG00051
OG00146
OG00247
OG003
Week 32
Title
Measurements
OG00050
OG00145
OG00246
OG003
Week 40
Title
Measurements
OG00049
OG00145
OG00246
OG003
Week 48
Title
Measurements
OG00048
OG00145
OG00246
OG003
Week 60
Title
Measurements
OG00048
OG00144
OG00246
OG003
Week 72
Title
Measurements
OG00048
OG00144
OG00245
OG003
Week 84
Title
Measurements
OG00047
OG00143
OG00246
OG003
Week 96
Title
Measurements
OG00042
OG00140
OG00245
OG003
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Baseline
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Week 1
Title
Measurements
OG00025
OG00120
OG00216
OG003
Week 2
Title
Measurements
OG00045
OG00145
OG00241
OG003
Week 4
Title
Measurements
OG00052
OG00149
OG00248
OG003
Week 8
Title
Measurements
OG00052
OG00149
OG00249
OG003
Week 12
Title
Measurements
OG00052
OG00149
OG00249
OG003
Week 16
Title
Measurements
OG00052
OG00148
OG00249
OG003
Week 20
Title
Measurements
OG00052
OG00148
OG00249
OG003
Week 24
Title
Measurements
OG00052
OG00147
OG00248
OG003
Week 32
Title
Measurements
OG00052
OG00147
OG00248
OG003
Week 40
Title
Measurements
OG00050
OG00147
OG00248
OG003
Week 48
Title
Measurements
OG00050
OG00147
OG00248
OG003
Week 60
Title
Measurements
OG00050
OG00146
OG00248
OG003
Week 72
Title
Measurements
OG00050
OG00146
OG00247
OG003
Week 84
Title
Measurements
OG00050
OG00145
OG00247
OG003
Week 96
Title
Measurements
OG00046
OG00143
OG00246
OG003
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Any AE
Title
Measurements
OG00050
OG00146
OG00246
OG00346
Any SAE
Title
Measurements
OG0005
OG0015
OG0027
OG003
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00053
OG00151
OG00251
OG00350
Title
Denominators
Categories
Alanine amino transferase
Title
Measurements
OG0007
OG00111
OG0023
OG00319
Cholesterol
Title
Measurements
OG00018
OG00116
OG00213
OG003
Creatinine kinase
Title
Measurements
OG00017
OG0016
OG0027
OG003
Lipase
Title
Measurements
OG00011
OG00113
OG00211
OG003
Triglycerides
Title
Measurements
OG0000
OG0011
OG0022
OG003
Alkaline phosphatase
Title
Measurements
OG0001
OG0010
OG0021
OG003
Amylase
Title
Measurements
OG0002
OG0013
OG0021
OG003
Aspartate amino transferase
Title
Measurements
OG00012
OG0018
OG0026
OG003
Carbon dioxide content/bicarbonate
Title
Measurements
OG00028
OG00124
OG00223
OG003
Creatinine
Title
Measurements
OG0000
OG0014
OG0020
OG003
Hypercalcemia
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hyperglycaemia
Title
Measurements
OG00016
OG00115
OG00217
OG003
Hyperkalemia
Title
Measurements
OG0000
OG0010
OG0021
OG003
Hypernatremia
Title
Measurements
OG0001
OG0011
OG0021
OG003
Hypocalcemia
Title
Measurements
OG0004
OG0015
OG0025
OG003
Hypoglycaemia
Title
Measurements
OG0003
OG0013
OG0025
OG003
Hypokalemia
Title
Measurements
OG0004
OG0011
OG0023
OG003
Hyponatremia
Title
Measurements
OG0006
OG00112
OG0027
OG003
Low-density lipoprotein cholesterol
Title
Measurements
OG00014
OG00115
OG00211
OG003
Magnesium
Title
Measurements
OG0007
OG0016
OG0025
OG003
Phosphate, inorganic
Title
Measurements
OG0009
OG00115
OG00214
OG003
Total bilirubin
Title
Measurements
OG0003
OG0014
OG0023
OG003
Activated partial thromboplastin time
Title
Measurements
OG0007
OG00112
OG0026
OG003
Hemoglobin
Title
Measurements
OG0000
OG0011
OG0020
OG003
International normalized ratio
Title
Measurements
OG0006
OG0019
OG0026
OG003
Platelet count
Title
Measurements
OG0001
OG0014
OG0021
OG003
Prothrombin time
Title
Measurements
OG0007
OG0018
OG0027
OG003
Total neutrophils
Title
Measurements
OG0009
OG0017
OG0026
OG003
White blood cell count
Title
Measurements
OG0001
OG0011
OG0021
OG003
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG0002
OG0011
OG0020
OG0031
Title
Denominators
Categories
A23A/V
Title
Measurements
OG0001
OG0010
OG0030
S255N
Title
Measurements
OG0001
OG0010
OG0030
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG0002
OG0011
OG0020
OG0031
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0030
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG0002
OG0011
OG0020
OG0030
Title
Denominators
Categories
<1 fold
Title
Measurements
OG0000
OG0011
1-<2 fold
Title
Measurements
OG0002
OG0010
2-<4 fold
Title
Measurements
OG0000
OG0010
4-<8 fold
Title
Measurements
OG0000
OG0010
>=8 fold
Title
Measurements
OG0000
OG0010
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00048
OG00146
OG00246
OG0030
Title
Denominators
Categories
Week 2, Pre-dose, n=46, 44, 43, 0
ParticipantsOG00046
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG0030
Title
Measurements
OG0000.3580± 0.18321
OG0010.6779± 0.44085
OG0021.4044± 0.88041
Week 2, 2-4 hours post-dose, n=31, 29, 29, 0
ParticipantsOG00031
ParticipantsOG00129
ParticipantsOG00229
ParticipantsOG0030
Week 12, Pre-dose, n= 46, 45, 44, 0
ParticipantsOG00046
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG0030
Week 12, 2-4 hours post-dose, n=48, 45, 45, 0
ParticipantsOG00048
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
Week 24, Pre-dose, n=45, 44, 44, 0
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG0030
Week 24, 2-4 hours post-dose, n=45, 45, 45, 0
ParticipantsOG00045
ParticipantsOG00145
ParticipantsOG00245
ParticipantsOG0030
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG0030
Title
Denominators
Categories
Title
Measurements
OG00016.0± 40
OG00123.1± 48
OG00248.1± 40
OG003
EFV 600 mg OD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG0030
Title
Denominators
Categories
Cmax
Title
Measurements
OG0001.10± 37
OG0011.71± 43
OG0023.40± 27
Cmin
Title
Measurements
OG0000.33± 64
OG0010.44± 68
OG0020.94± 74
Ctau
Title
Measurements
OG0000.37± 55
OG0010.45± 71
OG0021.05± 72
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg QD.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00049
OG00146
OG00246
OG0030
Title
Denominators
Categories
C0, Week 2, n=46, 44, 43, 0
ParticipantsOG00046
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG0030
Title
Measurements
OG0000.31± 58
OG0010.57± 62
OG0021.20± 61
C0, Week 12, n=46, 45, 44, 0
ParticipantsOG00046
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG0030
C0, Week 24, n=45, 44, 44, 0
ParticipantsOG00045
ParticipantsOG00144
ParticipantsOG00244
ParticipantsOG0030
C0 avg, n=48, 46, 46, 0
ParticipantsOG00048
ParticipantsOG00146
ParticipantsOG00246
ParticipantsOG0030
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
Units
Counts
Participants
OG00015
OG00115
OG00215
OG0030
Title
Denominators
Categories
Title
Measurements
OG0002.0(2.0 to 4.0)
OG0012.0(2.0 to 8.0)
OG0022.0(1.9 to 4.0)
Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG004
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)
Units
Counts
Participants
OG00015
OG00115
OG00215
OG0030
OG00445
Title
Denominators
Categories
AUC(0-tau)
Title
Measurements
OG0000.426
OG001-0.018
OG002-0.258
OG004-0.086
Cmax
Title
Measurements
OG0000.452
OG001-0.051
OG002-0.150
OG004
Ctau
Title
Measurements
OG0000.273
OG001-0.100
OG002-0.263
OG004
OG002
DTG 50 mg QD
Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG003
EFV 600 mg QD
Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally QD for 96 weeks.
OG004
Overall DTG
All participants who received DTG in any DTG treatment group (DTG 10 mg QD, DTG 25 mg QD, and DTG 50 mg QD)