Attachment Inhibitor Comparison in Heavily Treatment Experienced Patients
Official Title
A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir (BMS-663068/GSK3684934) in Heavily Treatment Experienced Subjects Infected With Multi-drug Resistant HIV-1 (BRIGHTE Study)
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
May 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 23, 2015Actual
Primary Completion Date
Aug 18, 2016Actual
Completion Date
Jan 28, 2027Estimated
First Submitted Date
Feb 9, 2015
First Submission Date that Met QC Criteria
Feb 12, 2015
First Posted Date
Feb 13, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 2, 2018
Results First Submitted that Met QC Criteria
Aug 20, 2018
Results First Posted Date
Sep 18, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 26, 2026
Last Update Posted Date
Jun 17, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Not provided
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
The purpose of this study is to determine whether the BMS Attachment Inhibitor (BMS-663068) is effective in the treatment of heavily treatment experienced HIV-1 patients with multi-drug resistance.
Detailed Description
Not provided
Conditions Module
Conditions
HIV Infections
Keywords
Not provided
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
371Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
A1: BMS-663068
Experimental
Phase 1: BMS-663068 600 mg tablets orally twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
B1: Placebo + BMS-663068
Active Comparator
Phase 1: Placebo twice daily for 8 days. Phase 2: BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
Other: Placebo
BMS-663068
Experimental
BMS-663068 600 mg tablets orally twice daily for 48 weeks or longer.
Drug: BMS-663068
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-663068
Drug
BMS-663068
A1: BMS-663068
B1: Placebo + BMS-663068
BMS-663068
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort
Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Day 1 and Day 8
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort
The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Men and non-pregnant women with chronic HIV-1 infection
Antiretroviral-experienced with documented historical or baseline resistance, intolerability, and/or contraindications to antiretrovirals in at least three classes
Failing current antiretroviral regimen with a confirmed plasma HIV-1 RNA ≥ 400 c/mL (first value from Investigator, second from Screening labs)
Must have ≤ 2 classes with at least 1 but no more than 2 fully-active antiretrovirals remaining which can be effectively combined to form a viable new regimen, based on current and/or documented historical resistance testing and tolerability and safety
Able to receive ≥ 1 fully active approved antiretroviral as part of the OBT from Day 9 onwards in the Randomized Cohort
Subjects without any remaining fully active approved antiretroviral may be enrolled in the Non-Randomized Cohort
Exclusion Criteria:
Chronic untreated Hepatitis B virus (HBV) (however, patients with chronic treated HBV are eligible)
HIV-2 infection
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 7 x ULN
Alkaline Phosphatase > 5 x ULN
Bilirubin ≥ 1.5 x Upper limit of normal (ULN) (unless subject is currently on atazanavir and has predominantly unconjugated hyperbilirubinemia)
Kozal M, Aberg J, Pialoux G, Cahn P, Thompson M, Molina JM, Grinsztejn B, Diaz R, Castagna A, Kumar P, Latiff G, DeJesus E, Gummel M, Gartland M, Pierce A, Ackerman P, Llamoso C, Lataillade M; BRIGHTE Trial Team. Fostemsavir in Adults with Multidrug-Resistant HIV-1 Infection. N Engl J Med. 2020 Mar 26;382(13):1232-1243. doi: 10.1056/NEJMoa1902493.
A total of 731 participants were screened, of which 371 were included in either Randomized Cohort or Non-randomized Cohort and received at least one dose of study treatment. The results presented are based on Week 96 interim analysis. Data collection is still on-going and additional results will be provided after study completion.
Recruitment Details
This was a 2 cohort Phase 3 study conducted in heavily treatment experienced (HTE) participants infected with multi-drug resistant human immunodeficiency virus (HIV)-1. Participants were assigned to either the Randomized Cohort (participants received either fostemsavir or placebo) or Non-randomized Cohort (all participants received fostemsavir).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
Periods
Title
Milestones
Reasons Not Completed
Double-blind Period-Up to 8 Days
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Placebo
Other
Placebo
B1: Placebo + BMS-663068
Day 1 and Day 8
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
The durability of response (that is, the number of participants achieving HIV-1 RNA <40 c/mL) at Weeks 24, 48 and 96 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24, 48 and 96 or those who changed OBT due to lack of efficacy through Weeks 24, 48 and 96 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA <40 c/mL) at Weeks 24, 48 and 96 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
At Weeks 24, 48 and 96
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Up to Week 96 analysis cut-off date
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Baseline and up to Week 96 analysis cut-off date
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Baseline and up to Week 96 analysis cut-off date
Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort
Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Up to Week 96 analysis cut-off date
Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Day 1 and Day 8
Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
Day 1 and Day 8
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Percentage CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort
Plasma samples were collected for emergent drug resistance testing. The number of participants with emergent viral genotypic substitutions of interest in the GP160 domain was identified by the next-generation sequencing (NGS) assay. Protocol defined virologic failure (PDVF) through Week 96 Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. The criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at any time after prior confirmed suppression to <400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, > 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is >=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at or after Week 24.
Week 96
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, i.e., the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR<1 indicates that FC is smaller on-treatment than at Baseline. FCR >3 indicates that on-treatment FC is 3 times greater than it was at Baseline.
Benlarbi M, Richard J, Clemente T, Bourassa C, Tolbert WD, Prakash M, Chandravanshi M, Clark A, Pazgier M, Durand M, Castagna A, Finzi A. Fostemsavir Decreases the Levels of Anti-gp120 CD4-Induced Antibodies in Heavily Treatment-Experienced People With HIV. J Infect Dis. 2026 Feb 18;233(2):247-256. doi: 10.1093/infdis/jiaf461.
Clark A, Prakash M, Chabria S, Pierce A, Castillo-Mancilla JR, Wang M, Du F, Tenorio AR. Inflammatory Biomarker Reduction With Fostemsavir Over 96 Weeks in Heavily Treatment-Experienced Adults With Multidrug-Resistant HIV-1 in the BRIGHTE Study. Open Forum Infect Dis. 2024 Aug 26;11(9):ofae469. doi: 10.1093/ofid/ofae469. eCollection 2024 Sep.
Llibre JM, Aberg JA, Walmsley S, Velez J, Zala C, Crabtree Ramirez B, Shepherd B, Shah R, Clark A, Tenorio AR, Pierce A, Du F, Li B, Wang M, Chabria S, Warwick-Sanders M. Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to 5 years in the phase 3 BRIGHTE study. Front Immunol. 2024 May 28;15:1394644. doi: 10.3389/fimmu.2024.1394644. eCollection 2024.
Aberg JA, Shepherd B, Wang M, Madruga JV, Mendo Urbina F, Katlama C, Schrader S, Eron JJ, Kumar PN, Sprinz E, Gartland M, Chabria S, Clark A, Pierce A, Lataillade M, Tenorio AR. Week 240 Efficacy and Safety of Fostemsavir Plus Optimized Background Therapy in Heavily Treatment-Experienced Adults with HIV-1. Infect Dis Ther. 2023 Sep;12(9):2321-2335. doi: 10.1007/s40121-023-00870-6. Epub 2023 Sep 26.
Gartland M, Cahn P, DeJesus E, Diaz RS, Grossberg R, Kozal M, Kumar P, Molina JM, Mendo Urbina F, Wang M, Du F, Chabria S, Clark A, Garside L, Krystal M, Mannino F, Pierce A, Ackerman P, Lataillade M. Week 96 Genotypic and Phenotypic Results of the Fostemsavir Phase 3 BRIGHTE Study in Heavily Treatment-Experienced Adults Living with Multidrug-Resistant HIV-1. Antimicrob Agents Chemother. 2022 Jun 21;66(6):e0175121. doi: 10.1128/aac.01751-21. Epub 2022 May 3.
Anderson SJ, Murray M, Cella D, Grossberg R, Hagins D, Towner W, Wang M, Clark A, Pierce A, Llamoso C, Ackerman P, Lataillade M. Patient-Reported Outcomes in the Phase III BRIGHTE Trial of the HIV-1 Attachment Inhibitor Prodrug Fostemsavir in Heavily Treatment-Experienced Individuals. Patient. 2022 Jan;15(1):131-143. doi: 10.1007/s40271-021-00534-y. Epub 2021 Jun 28.
Lataillade M, Lalezari JP, Kozal M, Aberg JA, Pialoux G, Cahn P, Thompson M, Molina JM, Moreno S, Grinsztejn B, Diaz RS, Castagna A, Kumar PN, Latiff GH, De Jesus E, Wang M, Chabria S, Gartland M, Pierce A, Ackerman P, Llamoso C. Safety and efficacy of the HIV-1 attachment inhibitor prodrug fostemsavir in heavily treatment-experienced individuals: week 96 results of the phase 3 BRIGHTE study. Lancet HIV. 2020 Nov;7(11):e740-e751. doi: 10.1016/S2352-3018(20)30240-X.
Lagishetty C, Moore K, Ackerman P, Llamoso C, Magee M. Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis. Clin Transl Sci. 2020 Jul;13(4):769-776. doi: 10.1111/cts.12763. Epub 2020 Mar 19.
FG001
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
FG002
Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period
Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
FG00069 subjects
FG001203 subjects
FG0020 subjects
COMPLETED
FG00068 subjects
FG001199 subjects
FG0020 subjects
NOT COMPLETED
FG0001 subjects
FG0014 subjects
FG0020 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
No longer meets study criteria
FG0000 subjects
FG0011 subjects
FG0020 subjects
Open Label Period-Up to 96 Weeks
Type
Comment
Milestone Data
STARTED
FG00068 subjects
FG001199 subjects
FG00299 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00068 subjects
FG001199 subjects
FG00299 subjects
Type
Comment
Reasons
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
No longer meets criteria
FG000
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
BG001
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
BG002
Non-randomized Cohort-fostemsavir 600 mg BID-Open Label Period
Eligible participants in the Non-randomized Cohort had zero remaining fully active and approved antiretroviral regimens at Baseline. Participants received fostemsavir 600 mg BID in combination with OBT.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00069
BG001203
BG00299
BG003371
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
BG00043.0± 11.02
BG00145.2± 12.72
BG00248.1± 11.53
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00160
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Race customized
Title
Measurements
Black or African American
BG00018
BG00142
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
Mean Change in Logarithm to the Base 10 (log10) HIV-1 Ribonucleic Acid (RNA) From Day 1 at Day 8-Randomized Cohort
Plasma samples were collected for analysis of HIV-1 RNA. Mean change in log10 HIV-1 RNA from Day 1 was estimated using analysis of covariance (ANCOVA) with log10 HIV-1 RNA change from Day 1 at Day 8 as dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 log10 HIV-1 RNA as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. The analysis was performed on Intent-to-Treat Exposed (ITT-E) Population which comprised of all randomized participants who received at least one dose of study treatment. Missing HIV-1 RNA values at Day 8 were imputed using (a) Day 1 Observation Carried Forward (D1OCF) for participants without a value during blinded treatment (i.e, imputing a zero change from Day 1) or (b) Last Observation Carried Forward (LOCF) for participants with an early value during blinded treatment before the Day 8 analysis visit window.
ITT-E Population. Participants with missing Day 1 HIV-1 RNA values were not analyzed.
Posted
Least Squares Mean
95% Confidence Interval
Log10 copies per milliliter (c/mL)
Day 1 and Day 8
ID
Title
Description
OG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
OG001
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
Units
Counts
Participants
OG00069
OG001201
Title
Denominators
Categories
Title
Measurements
OG000-0.166(-0.326 to -0.007)
OG001-0.791(-0.885 to -0.698)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
<0.0001
Hypothesis test:µfostemsavir=µPlacebo where µ is a common intercept.
Mean Difference (Net)
-0.625
2-Sided
95
-0.810
-0.441
Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.
Superiority
Secondary
Percentage of Participants With HIV-1 RNA Decreases From Day 1 That Exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8-Randomized Cohort
The percentage of participants in the Randomized Cohort with HIV-1 RNA decreases from Day 1 that exceed 0.5 log10 c/mL and 1.0 log10 c/mL at Day 8 was determined by comparing HIV-1 RNA Day 1 measurement of each participant to their Day 8 measurement. This was an ITT analysis that classified participants without HIV-1 RNA at Day 1 or Day 8 as failures. The percentage of responders along with 95% confidence interval based on Wilson score is presented.
ITT-E Population
Posted
Number
95% Confidence Interval
Percentage of participants
Day 1 and Day 8
ID
Title
Description
OG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
OG001
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
Secondary
Percentage of Participants With HIV-1 RNA <40 c/mL at Weeks 24, 48 and 96-Randomized Cohort
The durability of response (that is, the number of participants achieving HIV-1 RNA <40 c/mL) at Weeks 24, 48 and 96 of open-label fostemsavir plus OBT in the Randomized Cohort was assessed using the Food and Drug Administration (FDA) snapshot algorithm in which participants without HIV-1 RNA at Weeks 24, 48 and 96 or those who changed OBT due to lack of efficacy through Weeks 24, 48 and 96 were counted as failures. The percentage of participants in the Randomized Cohort who achieved virologic success (HIV-1 RNA <40 c/mL) at Weeks 24, 48 and 96 is presented along with 95% Wilson confidence interval. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
ITT-E Population
Posted
Number
95% Confidence Interval
Percentage of participants
At Weeks 24, 48 and 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Secondary
Number of Participants With On-treatment Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation (AELD)-Randomized Cohort
An SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or causes prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; an important medical event that may jeopardize the participant or require intervention. Number of participants with on-treatment SAEs and AEs leading to withdrawal of study treatment is presented. SAEs and AELDs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Safety Population.
Posted
Count of Participants
Participants
Up to Week 96 analysis cut-off date
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Secondary
Number of Participants With Toxicity Grade Increase in Clinical Chemistry Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Laboratory toxicities were graded for severity according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with clinical chemistry toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Baseline and up to Week 96 analysis cut-off date
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Secondary
Number of Participants With Toxicity Grade Increase in Hematology Results to Grade 3-4 Relative to Baseline-Randomized Cohort
Laboratory toxicities were graded for severity according to the DAIDS grading system: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (potentially life-threatening). Baseline is defined as the latest pre-dose assessment. The number of participants with hematology toxicity grade increase to Grade 3-4 at anytime post-Baseline relative to Baseline is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Safety Population. Only participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Posted
Count of Participants
Participants
Baseline and up to Week 96 analysis cut-off date
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Secondary
Number of Participants With Centers for Disease Control (CDC) Class C Events-Randomized Cohort
Disease progression during open label fostemsavir plus OBT was assessed based on the occurrence of new AIDS defining events (CDC Class C events) or death. The number of participants with on-treatment CDC Class C AIDS events is presented. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
Safety Population
Posted
Count of Participants
Participants
Up to Week 96 analysis cut-off date
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Units
Counts
Participants
Secondary
Change From Day 1 in Cluster of Differentiation (CD) 4+ T-cell Count at Day 8-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell counts from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an in-dependent variable, and Day 1 CD4+ cell count as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (i.e., imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Posted
Least Squares Mean
95% Confidence Interval
Cells per cubic millimeter
Day 1 and Day 8
ID
Title
Description
OG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
OG001
Randomized Cohort-fostemsavir 600 mg BID
Secondary
Change in CD4+ T- Cell Count Percentage From Day 1 at Day 8-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Mean change in CD4+ T- cell count percentage from Day 1 at Day 8 was analyzed using one-way ANCOVA with change of CD4+ cell count percentage from Day 1 at Day 8 as the dependent variable, treatment (fostemsavir or placebo) as an independent variable, and Day 1 CD4+ cell count percentage as a continuous covariate. Change from Day 1 was calculated as value at Day 8 minus value at Day 1. Missing CD4+ cell count values at Day 8 were imputed using (a) D1OCF for participants without a value during blinded treatment (ie, imputing a zero change from Day 1), or (b) LOCF for participants with an early value during blinded treatment before the Day 8 analysis visit window.
ITT-E Population. Only those participants with data available at the specified time points were analyzed.
Posted
Least Squares Mean
95% Confidence Interval
Percentage of CD4+T- cells
Day 1 and Day 8
ID
Title
Description
OG000
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
OG001
Randomized Cohort-fostemsavir 600 mg BID
Secondary
Change From Baseline in log10 HIV-1 RNA for Fostemsavir When Given With OBT Through Week 96-Randomized Cohort
Blood samples were collected for the analysis of HIV-1 RNA. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline. All the participants received fostemsavir during the open-label period irrespective of the original arms to which they were randomized; hence, the combined totals for Randomized Cohort is presented as pre-specified in protocol and reporting and analysis plan.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Log10 c/mL
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Units
Counts
Secondary
Change From Baseline in CD4+ T- Cell Count Through Week 96-Randomized Cohort
CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Cells per cubic millimeter
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in CD4+ T- Cell Count Percentage Through Week 96
Percentage CD4+ T- cell counts were assessed by flow cytometry. Baseline is defined as the last non-missing value on or before the date of first dose of study treatment. Change from Baseline was calculated as the value at post-dose visit minus the value at Baseline.
ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
Posted
Mean
Standard Deviation
Percentage of CD4+ T- cells
Baseline and at Day 8, Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84 and 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks
Units
Counts
Participants
OG000
Secondary
Number of Participants With Treatment-emergent Viral Genotypic Substitution of Interest in the GP160 Domain as a Measure of Genotypic Resistance-Randomized Cohort
Plasma samples were collected for emergent drug resistance testing. The number of participants with emergent viral genotypic substitutions of interest in the GP160 domain was identified by the next-generation sequencing (NGS) assay. Protocol defined virologic failure (PDVF) through Week 96 Population comprised of all participants with available phenotypic and genotypic resistance data meeting at the time protocol defined virologic failure (PDVF) was met. The criteria for PDVF was a) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at any time after prior confirmed suppression to <400 c/mL prior to Week 24 or Confirmed, or last available prior to discontinuation, > 1 log10 c/mL increase in HIV-1 RNA at any time above nadir level where nadir is >=40 c/mL prior to Week 24. b) Confirmed, or last available prior to discontinuation, HIV-1 RNA >=400 c/mL at or after Week 24.
PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.
Posted
Count of Participants
Participants
Week 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Secondary
Number of Participants With Indicated Fold Change Ratio (FCR) Using the Monogram PhenoSense Entry Assay-Randomized Cohort
The phenotypic resistance to a drug is defined in terms of a fold change (FC) in IC50s, i.e., the ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of a reference strain (wild type control). FCR was calculated as FC at PDVF divided by Baseline FC. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. FCR<1 indicates that FC is smaller on-treatment than at Baseline. FCR >3 indicates that on-treatment FC is 3 times greater than it was at Baseline.
PDVF through Week 96 Population. Only participants available at the specified time point were analyzed.
Posted
Count of Participants
Participants
Week 96
ID
Title
Description
OG000
Randomized Cohort
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants were randomized to receive fostemsavir 600 mg BID or placebo along with their current failing antiretroviral regimen during the double-blind period for 8 days. During the open-label period, all participants received open-label fostemsavir 600 mg BID in combination with OBT for at least 96 weeks.
Units
Counts
Participants
Time Frame
On-treatment non-SAEs and SAEs were collected from the start of study treatment until Week 96 data cut-off date. The data presented for Randomized Cohort-Placebo and Randomized Cohort-fostemsavir 600 mg BID represent safety events during the double-blind period (Up to Day 8). The safety data presented in the Randomized Cohort-Total, Non-Randomized Cohort-fostemsavir 600 mg BID and Fostemsavir Total columns represent safety events during fostemsavir dosing until the Week 96 data cut-off date.
Description
Non-SAEs and SAEs were collected in the Safety Population which comprised of all participants who received at least one dose of study treatment. One participant was excluded from the Randomized Cohort-Total and Total fostemsavir population as the participant took only placebo and had discontinued during the double-blind period.
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
Randomized Cohort-Placebo
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received placebo twice daily (BID) along with their currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants received fostemsavir 600 mg BID with an optimized background therapy (OBT).
2
69
2
69
16
69
EG001
Randomized Cohort-fostemsavir 600 mg BID
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
10
203
4
203
45
203
EG002
Non-randomized Cohort-fostemsavir 600 mg BID
This reporting group includes HTE HIV-1 infected participants who were assigned to the Non-randomized Cohort and received fostemsavir 600 mg BID and OBT. Non-randomized Cohort participants are assigned based on their screening status of having no remaining classes of fully active antiretroviral that can combined in a new drug regimen. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
17
99
48
99
92
99
EG003
Randomized Cohort-Total
This reporting group includes all participants in the Randomized Cohort. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
12
271
92
271
214
271
EG004
Total Fostemsavir
This reporting group included all enrolled participants (Randomized Cohort and Non-randomized Cohort) and who received fostemsavir 600 mg during the open-label period. The data reported are safety events during fostemsavir dosing until the Week 96 data cut-off date.
29
370
140
370
306
370
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0012 events2 affected203 at risk
EG0024 events3 affected99 at risk
EG00315 events12 affected271 at risk
EG00419 events15 affected370 at risk
Cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0024 events3 affected99 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0024 events4 affected99 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Anal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events3 affected99 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events3 affected99 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events3 affected99 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events2 affected99 at risk
EG003
Seizure
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events2 affected99 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Cervical dysplasia
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Cytomegalovirus colitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG0020 events0 affected99 at risk
EG003
HIV-associated neurocognitive disorder
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Hepatitis A
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Immune reconstitution inflammatory syndrome
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events1 affected99 at risk
EG003
Penile squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Progressive multifocal leukoencephalopathy
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Pseudomonal sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Septic shock
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Abdominal wall abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Adenovirus infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Anal ulcer
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Anogenital dysplasia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Anorectal cellulitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Arterial bypass thrombosis
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Blood HIV RNA increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Bronchitis bacterial
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Bronchopulmonary aspergillosis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Burns third degree
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cardiovascular disorder
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Central nervous system immune reconstitution inflammatory response
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Chest pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Clostridium difficile infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cytomegalovirus chorioretinitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events1 affected99 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Diffuse large B-cell lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Disorientation
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Disseminated cytomegaloviral infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Facial pain
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
General physical health deterioration
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Generalised oedema
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hepatitis B reactivation
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Histoplasmosis disseminated
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Inflammatory bowel disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Kaposi's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Kidney infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Kidney rupture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lumbar radiculopathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lung squamous cell carcinoma stage IV
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Malabsorption
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Meningitis coccidioides
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Meningoencephalitis viral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Mononeuropathy
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Muscle spasticity
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Non-small cell lung cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Open fracture
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Orchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Oropharyngeal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Osteomyelitis acute
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Ovarian cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Paranoia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pharyngeal oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Pneumonia cytomegaloviral
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0022 events1 affected99 at risk
EG003
Pneumonia pneumococcal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pneumonia streptococcal
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Prostatic abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Reactive gastropathy
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Salmonella bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Schizophrenia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Septic rash
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Shunt thrombosis
Injury, poisoning and procedural complications
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Tonsil cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Transaminases increased
Investigations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Tremor
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Tuberculosis liver
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0021 events1 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG0020 events0 affected99 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0003 events3 affected69 at risk
EG0018 events8 affected203 at risk
EG00248 events25 affected99 at risk
EG00384 events60 affected271 at risk
EG004132 events85 affected370 at risk
Nausea
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0004 events4 affected69 at risk
EG00114 events14 affected203 at risk
EG00231 events21 affected99 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG00221 events15 affected99 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0012 events2 affected203 at risk
EG00224 events19 affected99 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0005 events5 affected69 at risk
EG0016 events6 affected203 at risk
EG00213 events12 affected99 at risk
EG003
Pyrexia
General disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0011 events1 affected203 at risk
EG00224 events16 affected99 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG00212 events11 affected99 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0027 events5 affected99 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG00215 events13 affected99 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0012 events2 affected203 at risk
EG00213 events9 affected99 at risk
EG003
Fatigue
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected69 at risk
EG0013 events3 affected203 at risk
EG00216 events16 affected99 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG00213 events11 affected99 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG00211 events9 affected99 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0013 events3 affected203 at risk
EG0027 events6 affected99 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG00214 events12 affected99 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0013 events3 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG00213 events10 affected99 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG00214 events10 affected99 at risk
EG003
Asthenia
General disorders
MedDRA 20.1
Systematic Assessment
EG0002 events2 affected69 at risk
EG0012 events2 affected203 at risk
EG00213 events12 affected99 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0012 events2 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0023 events3 affected99 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0027 events7 affected99 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0012 events2 affected203 at risk
EG0022 events2 affected99 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events5 affected99 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG0028 events6 affected99 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events6 affected99 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0029 events8 affected99 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG0028 events6 affected99 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0028 events6 affected99 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events6 affected99 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0011 events1 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0025 events5 affected99 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events5 affected99 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 20.1
Systematic Assessment
EG0001 events1 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events5 affected99 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0026 events6 affected99 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 20.1
Systematic Assessment
EG0000 events0 affected69 at risk
EG0010 events0 affected203 at risk
EG0025 events5 affected99 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
GSKClinicalSupportHD@gsk.com
ID
Term
D015658
HIV Infections
Ancestor Terms
ID
Term
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C576364
fostemsavir
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0014 subjects
FG0024 subjects
Pregnancy
FG0000 subjects
FG0011 subjects
FG0020 subjects
Non-compliance with study drug
FG0003 subjects
FG0018 subjects
FG0026 subjects
Lost to Follow-up
FG0004 subjects
FG0013 subjects
FG0021 subjects
Death
FG0001 subjects
FG0017 subjects
FG00215 subjects
Withdrawal by Subject
FG0000 subjects
FG0015 subjects
FG0021 subjects
Adverse Event
FG0003 subjects
FG0012 subjects
FG0024 subjects
Lack of Efficacy
FG0003 subjects
FG0019 subjects
FG0026 subjects
Ongoing at the time of analysis
FG00054 subjects
FG001159 subjects
FG00261 subjects
45.6
± 12.20
10
BG00382
Male
BG00057
BG001143
BG00289
BG003289
23
BG00383
American Indian or Alaska Native
BG0001
BG0016
BG0021
BG0038
Asian
BG0000
BG0012
BG0020
BG0032
Native Hawaiian or other Pacific islander
BG0000
BG0011
BG0020
BG0031
White
BG00048
BG001137
BG00274
BG003259
Mixed
BG0001
BG0016
BG0021
BG0038
Hispanic
BG0000
BG0012
BG0020
BG0032
Mestizo
BG0001
BG0012
BG0020
BG0033
North African
BG0000
BG0011
BG0020
BG0031
Mulatto
BG0000
BG0011
BG0020
BG0031
Brown
BG0000
BG0012
BG0020
BG0032
White and African descent
BG0000
BG0011
BG0020
BG0031
Units
Counts
Participants
OG00069
OG001203
Title
Denominators
Categories
>0.5 log10 c/mL
Title
Measurements
OG00018.84(11.35 to 29.61)
OG00164.53(57.74 to 70.79)
>1.0 log10 c/mL
Title
Measurements
OG00010.14(5.00 to 19.49)
OG00145.81(39.10 to 52.68)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Net)
45.69
2-Sided
95
32.95
55.45
Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for >0.5 log10 c/mL.
Other
OG000
OG001
Mean Difference (Net)
35.67
2-Sided
95
24.16
44.25
Difference between treatment groups (fostemsavir 600 mg BID-Placebo) and 95% confidence interval using Newcombe method is presented for >1.0 log10 c/mL.
Other
Units
Counts
Participants
OG000272
Title
Denominators
Categories
Week 24
Title
Measurements
OG00053(47.0 to 58.8)
Week 48
Title
Measurements
OG00054(47.7 to 59.5)
Week 96
Title
Measurements
OG00060(54.0 to 65.6)
Units
Counts
Participants
OG000272
Title
Denominators
Categories
SAE
Title
Measurements
OG00092
AELD
Title
Measurements
OG00014
Units
Counts
Participants
OG000272
Title
Denominators
Categories
Albumin; n=268
ParticipantsOG000268
Title
Measurements
OG0001
Alkaline phosphatase; n=268
ParticipantsOG000268
Title
Measurements
OG0003
Alanine aminotransferase; n=268
ParticipantsOG000268
Title
Measurements
OG00014
Amylase; n=268
ParticipantsOG000268
Title
Measurements
OG0002
Aspartate aminotransferase; n=268
ParticipantsOG000268
Title
Measurements
OG00010
Bicarbonate; n=268
ParticipantsOG000268
Title
Measurements
OG0001
Direct bilirubin; n=268
ParticipantsOG000268
Title
Measurements
OG00020
Bilirubin; n=268
ParticipantsOG000268
Title
Measurements
OG0007
Calcium; n=268
ParticipantsOG000268
Title
Measurements
OG0009
Cholesterol; n=221
ParticipantsOG000221
Title
Measurements
OG00010
Creatine kinase; n=268
ParticipantsOG000268
Title
Measurements
OG0006
Creatinine; n=268
ParticipantsOG000268
Title
Measurements
OG00052
Estimated creatinine clearance; n=268
ParticipantsOG000268
Title
Measurements
OG00075
Glucose/hyperglycemia; n=267
ParticipantsOG000267
Title
Measurements
OG0006
Glucose/hypoglycemia; n=267
ParticipantsOG000267
Title
Measurements
OG0002
Potassium/hyperkalemia; n=268
ParticipantsOG000268
Title
Measurements
OG0004
Potassium/hypokalemia; n=268
ParticipantsOG000268
Title
Measurements
OG0000
Low density lipoprotein (LDL) cholesterol; n=216
ParticipantsOG000216
Title
Measurements
OG0008
Lipase; n=268
ParticipantsOG000268
Title
Measurements
OG00013
Sodium/hypernatremia; n=268
ParticipantsOG000268
Title
Measurements
OG0000
Sodium/hyponatremia; n=268
ParticipantsOG000268
Title
Measurements
OG0000
Triglycerides; n=221
ParticipantsOG000221
Title
Measurements
OG00011
Urate; n=268
ParticipantsOG000268
Title
Measurements
OG0009
Units
Counts
Participants
OG000272
Title
Denominators
Categories
Hemoglobin; n=268
ParticipantsOG000268
Title
Measurements
OG00016
Neutrophils; n=268
ParticipantsOG000268
Title
Measurements
OG00010
Platelets; n=267
ParticipantsOG000267
Title
Measurements
OG0002
Leukocytes; n=268
ParticipantsOG000268
Title
Measurements
OG0004
OG000
272
Title
Denominators
Categories
Title
Measurements
OG00023
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
Units
Counts
Participants
OG00069
OG001196
Title
Denominators
Categories
Title
Measurements
OG00018.9(4.7 to 33.0)
OG00118.5(10.1 to 26.8)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Net)
-0.4
2-Sided
95
-16.8
16.0
Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.
Other
Eligible participants in the Randomized Cohort had one to two fully active antiretrovirals remaining at Baseline. Participants received fostemsavir 600 milligram (mg) BID along with currently failing antiretroviral regimen for 8 days during the randomized, double-blind period. During the open-label period, all participants continued to receive fostemsavir 600 mg BID with an OBT.
Units
Counts
Participants
OG00069
OG001196
Title
Denominators
Categories
Title
Measurements
OG0000.243(-0.216 to 0.703)
OG0010.860(0.588 to 1.133)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mean Difference (Net)
0.617
2-Sided
95
0.082
1.151
Difference in covariate-adjusted least squares means between treatment groups (Fostemsavir 600 mg BID-Placebo) is presented.