A Study To Assess GW433908 (Fosamprenavir) Containing Reg... | NCT00296504 | Trialant
NCT00296504
Sponsor
ViiV Healthcare
Status
Completed
Last Update Posted
Apr 19, 2013Estimated
Enrollment
753Actual
Phase
Phase 3
Conditions
Infection, Human Immunodeficiency Virus
Interventions
fosamprenavir (GW433908)
ritonavir
Countries
United States
Brazil
Chile
France
Italy
Portugal
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00296504
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
APV30005
Secondary IDs
Not provided
Brief Title
A Study To Assess GW433908 (Fosamprenavir) Containing Regimens In HIV-1 Infected Subjects
Official Title
An Open-Label Phase III Study to Assess the Long Term Safety Profile of GW433908 Containing Regimens in HIV-1 Infected Subjects
Acronym
Not provided
Organization
ViiV HealthcareINDUSTRY
Status Module
Record Verification Date
Jun 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Nov 2001
Primary Completion Date
Oct 2010Actual
Completion Date
Oct 2010Actual
First Submitted Date
Feb 24, 2006
First Submission Date that Met QC Criteria
Feb 24, 2006
First Posted Date
Feb 27, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 30, 2011
Results First Submitted that Met QC Criteria
Sep 30, 2011
Results First Posted Date
Nov 8, 2011Estimated
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
Apr 11, 2013
Last Update Posted Date
Apr 19, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ViiV HealthcareINDUSTRY
Collaborators
Name
Class
GlaxoSmithKline
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
GW433908 (fosamprenavir; FPV)is a pro-drug of amprenavir (APV) which is more water soluble and can be formulated into a tablet with a reduced pill burden (four 700mg tablets of FPV versus sixteen 150mg capsules daily for APV. This study is designed to provide additional information on long term safety and tolerability of FPV containing regimens for those subjects who received FPV in previous GlaxoSmithKline studies.
Detailed Description
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship.
Conditions Module
Conditions
Infection, Human Immunodeficiency Virus
Keywords
antiretroviral therapy naive subjects
fosamprenavir
HIV-1
protease inhibitor
pro-drug
antiretroviral therapy
LEXIVA
AGENERASE
GW433908
amprenavir
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
753Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
fosamprenavir (GW433908)
Drug
ritonavir
Drug
fosamprenavir (GW433908)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Any Adverse Event (AE): Interim Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants With Any Adverse Event (AE): Final Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
Post January 2006; for up to 241 weeks
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
Weeks 120, 180, 204, 216, and 432
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant/non-lactating females >/=13 years of age (or >/= 18 years of age according to local requirements).
Received fosamprenavir through prior participation in APV20001, APV30002, APV30003 or PRO30017 or have participated in APV30001 or other studies as deemed appropriate by the project team.
Exclusion Criteria:
Permanent discontinuation of GW433908 in a previous study due to intolerance.
An active CDC Class C Event.
Any condition which, in the opinion of the investigator, would preclude a subject from participation.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
13 Years
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
GSK Clinical Trials
ViiV Healthcare
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
GSK Investigational Site
Fountain Valley
California
92708
United States
GSK Investigational Site
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants are divided into arms depending on the regimen they received in Studies APV30001, APV30002, and APV30003 or whether they were PI-naïve or PI-experienced at the time they enrolled into other studies. For the final analysis, 111 participants are included who continued in APV30005 after 31 January 2006 until study completion.
Recruitment Details
APV30005 enabled Human Immunodeficiency Virus (HIV)-infected participants who had received a Fosamprenavir (FPV)-containing or other regimen in a number of studies, including APV30001, APV30002, and APV30003, to receive FPV until 31 January 2006 (Interim Analysis) or until commercial supplies of FPV were available locally, whichever was later.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
FPV Population (APV30001)
Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
FG001
NFV Population (APV30001)
Periods
Title
Milestones
Reasons Not Completed
Interim Analysis
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
Argentina
Australia
Austria
Belgium
Canada
Costa Rica
Germany
Hungary
Israel
Latvia
Panama
Poland
Puerto Rico
South Africa
Switzerland
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Baseline (Day 1) and Weeks 48, 96, 132, and 168
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
Weeks 120, 180, 204, 216, and 432
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
Baseline (Day 1) and Weeks 48, 96, 132, and 168
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
Weeks 120, 180, 204, 216, and 432
Baseline and Weeks 48, 120, 180, and 216
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
Baseline and Weeks 12, 24, 48, 60, 96, and 132
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Baseline and Weeks 48, 120, 168, 180, 204, and 216
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
Baseline and Weeks 24, 48, 96, 132, and 168
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
Weeks 180, 240, 300, 360, 420, and 432
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed.
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
San Francisco
California
94115-1931
United States
GSK Investigational Site
Denver
Colorado
80262
United States
GSK Investigational Site
Fort Lauderdale
Florida
33145
United States
GSK Investigational Site
Orlando
Florida
32804
United States
GSK Investigational Site
Orlando
Florida
32806
United States
GSK Investigational Site
Sarasota
Florida
34239
United States
GSK Investigational Site
Tampa
Florida
33614
United States
GSK Investigational Site
Manhasset
New York
11030
United States
GSK Investigational Site
Galveston
Texas
77555-1188
United States
GSK Investigational Site
Campinas
São Paulo
13083970
Brazil
GSK Investigational Site
Santiago
Región Metro de Santiago
Chile
GSK Investigational Site
Le Kremlin-Bicêtre
94275
France
GSK Investigational Site
Marseille
13005
France
GSK Investigational Site
Paris
75475
France
GSK Investigational Site
Paris
75970
France
GSK Investigational Site
Vandœuvre-lès-Nancy
54511
France
GSK Investigational Site
Villejuif
94805
France
GSK Investigational Site
Genoa
Liguria
16128
Italy
GSK Investigational Site
Coimbra
3000-075
Portugal
GSK Investigational Site
Badajoz
6080
Spain
GSK Investigational Site
Barcelona
08036
Spain
GSK Investigational Site
London
NW3 2QG
United Kingdom
GSK Investigational Site
London
SE1 7EH
United Kingdom
FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
FG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
FG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
FG004
FPV/RTV Once Daily (QD) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
FG005
FPV/RTV Twice Daily (BID) Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
FG006
Protease Inhibitor (PI)-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
FG007
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
FG008
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
FG000119 subjects
FG00118 subjects
FG002221 subjects
FG00354 subjects
FG00473 subjects
FG00578 subjects
FG006104 subjects
FG00786 subjects
FG0080 subjects
Ongoing
FG00032 subjects
FG00112 subjects
FG00216 subjects
FG00322 subjects
FG0040 subjects
FG0050 subjects
FG00630 subjects
FG0071 subjects
FG0080 subjects
COMPLETED
FG00043 subjects
FG0010 subjects
FG002116 subjects
FG00311 subjects
FG00436 subjects
FG00541 subjects
FG00630 subjects
FG00737 subjects
FG0080 subjects
NOT COMPLETED
FG00076 subjects
FG00118 subjects
FG002105 subjects
FG00343 subjects
FG00437 subjects
FG00537 subjects
FG00674 subjects
FG00749 subjects
FG0080 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0008 subjects
FG0010 subjects
FG00212 subjects
FG0030 subjects
FG0045 subjects
FG0055 subjects
FG0069 subjects
FG0073 subjects
FG0080 subjects
Lost to Follow-up
FG00013 subjects
FG0013 subjects
FG00226 subjects
FG0038 subjects
FG004
Clinical Progression
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Insufficient Viral Load Response
FG0005 subjects
FG0011 subjects
FG00212 subjects
FG0032 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG0034 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Insufficient CD4 Response
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Switched to Commercially Available Drug
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
FG004
Pregnancy
FG0004 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Participant Non-compliant
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Participant Wanted to Become Pregnant
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
To Simplify Treatment
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Participant Had Problems with Alcohol
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Participant Moved
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Participant Was Incarcerated
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Resistance to FPV
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Principle Investigator Discretion
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Principle Investigator Terminated Study
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Non-adherence
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Site Closing
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Personnel at Site
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Missed Schedule Date
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Inclusion in Other Protocol
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Participant Stopped
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician and Participant Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant Stopped HIV Medications
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Study Ended
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Participant Needed Interferon
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Ongoing
FG00032 subjects
FG00112 subjects
FG00216 subjects
FG00322 subjects
FG004
Final Analysis
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG008111 subjectsContinued in study; commercial supplies of FPV were unavailable locally at end of Interim Analysis.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
BG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
BG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
BG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
BG004
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
BG005
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
BG006
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
BG007
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000119
BG00118
BG002221
BG00354
BG00473
BG00578
BG006104
BG00786
BG008753
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00036.3(17 to 70)
BG00135.8(22 to 54)
BG00237.7(19 to 69)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00036
BG0019
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG00034
BG0011
BG002
Number of Participants with the Indicated CDC Classification of HIV Infection
The Centers for Disease Control and Prevention (CDC) 1993 classification system for HIV infection was based on three clinical categories (A, B, and C). Category A comprised asymptomatic acute or primary HIV infection or persistent generalized lymphadenopathy (lymphnode disease). Category B comprised symptomatic conditions not included in clinical categories A or C but attributed to a cell-mediated immunity defect or for which the clinical course or management was complicated by HIV infection. Category C comprised AIDS-defining conditions.
Number
participants
Title
Denominators
Categories
Asymptomatic or lymphadenopathy
Title
Measurements
BG00081
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Any Adverse Event (AE): Interim Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
Posted
Number
participants
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
OG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
OG004
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG005
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG006
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
OG007
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Units
Counts
Participants
OG000119
OG00118
OG002221
OG003
Title
Denominators
Categories
Title
Measurements
OG000117
OG00116
OG002215
OG003
Primary
Number of Participants With Any Adverse Event (AE): Final Analysis
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A list of all adverse events is reported in the "Other (Non-Serious) Adverse Events" section.
All participants who remained in the study after January 31, 2006.
Posted
Number
participants
Post January 2006; for up to 241 weeks
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Primary
Change From Baseline in the Indicated Clinical Chemistry Parameters at Weeks 48, 96, 120, 132, 168, 180, 204, and 216
Fasting blood samples of participants were collected for the assessment of triglycerides (Tri.), cholesterol (Chol.), high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG). Change from Baseline at Weeks (W) 48, 96, 120, 132, 168, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
milligrams per deciliter (mg/dl)
Baseline (Day 1) and Weeks 48, 96, 120, 132, 168, 180, 204, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
Primary
Median Values of the Indicated Clinical Chemistry Parameters at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of triglycerides, cholesterol, high density cholesterol (HDL), low density cholesterol (LDL), and fasting blood glucose (FBG).
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
milligrams per deciliter (mg/dl)
Weeks 120, 180, 204, 216, and 432
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Primary
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 120, 180, 204, and 216
blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
ratio
Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
Primary
Change From Baseline in the Total Cholesterol/HDL Ratio at Weeks 48, 96, 132, and 168
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
ratio
Baseline (Day 1) and Weeks 48, 96, 132, and 168
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
Primary
Median Value of the Total Cholesterol/HDL Ratio at Weeks 120, 180, 204, 216, and 432
Fasting blood samples of participants were collected for the assessment of the total cholesterol/HDL ratio. The ratio of total cholesterol/HDL was calculated by dividing the value of total cholesterol by the value of HDL.
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
ratio
Weeks 120, 180, 204, 216, and 432
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Primary
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 120, 180, 204, and 216
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 120, 180, 204, and 216 was calculated as the value at that particular week minus the value at Baseline (Day 1).
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
units per liter (U/L)
Baseline (Day 1) and Weeks 48, 120, 180, 204, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
Primary
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase at Weeks 48, 96, 132, and 168
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase. Change from Baseline at Weeks 48, 96, 132, and 168 was calculated as the value at that particular week minus the value at Baseline (Day 1).
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
units per liter (U/L)
Baseline (Day 1) and Weeks 48, 96, 132, and 168
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
Primary
Median Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and Serum Lipase Values at Weeks 120, 180, 204, 216, and 432
Blood samples of participants were collected for the assessment of AST, ALT, and serum lipase.
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Inter-Quartile Range
units per liter (U/L)
Weeks 120, 180, 204, 216, and 432
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Secondary
Percentage of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 and <50 Copies Per Milliliter at Baseline and Weeks 48, 120, 180, and 216 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. No participants were analyzed in the NPV APV30001 arm due to their small number.
Posted
Number
percentage of participants
Baseline and Weeks 48, 120, 180, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
Secondary
Percentage of Participants With Plasma HIV-1RNA <400 and <50 Copies Per Milliliter at Baseline and Weeks 12, 24, 48, 60, 96, and 132 (MD=F and Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the MD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point are classified as non-responders. In the observed analysis (OA), data are presented for the number of participants still enrolled in the study at a certain time point.
All participants receiving FPV or FPV/RTV in Study APV3005 having participated in Study APV30003 or other studies. The PI-naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Posted
Number
percentage of participants
Baseline and Weeks 12, 24, 48, 60, 96, and 132
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
Secondary
Percentage of Participants With Plasma HIV-1RNA <50 Copies Per Milliliter at Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432 (Observed)
Blood samples of participants were collected for the assessment of HIV-1RNA copies in plasma. Viral load, measured in RNA copies per milliliter of plasma,is an efficacy measure for antiretroviral drugs.
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed. In the observed analysis, data are presented for the number of participants still enrolled in the study who are classified as responders.
Posted
Number
percentage of participants
Baseline and Weeks 120, 180, 240, 300, 360, 420, and 432
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Secondary
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 48, 120, 168, 180, 204, and 216: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Posted
Median
Full Range
cells per millimeters cubed (cells/mm^3)
Baseline and Weeks 48, 120, 168, 180, 204, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
Secondary
Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and Weeks 24, 48, 96, 132, and 168: Observed Analysis
Blood samples of participants were collected for the assessment of CD4+ cell count. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 and other studies. Only those participants contributing data at the indicated time points were analyzed. The PI-naÑ—ve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Posted
Median
Full Range
cells per millimeters cubed (cells/mm^3)
Baseline and Weeks 24, 48, 96, 132, and 168
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
Secondary
Median Plasma HIV-1 RNA at Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously particpated in Study APV30001 or Study APV30002. Only those participants contributing data at the indicated time points were analyzed. Participants in the NFV populations had received antiretroviral therapy prior to Baseline.
Posted
Median
Full Range
log 10 copies per milliliter
Baseline and Weeks 24, 48, 72, 96, 120, 144, 168, 180, 204, and 216
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
OG003
NFV Population (APV30002)
Secondary
Median Plasma HIV-1 RNA at Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
All participants receiving FPV or FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies. Only those participants contributing data at the indicated time points were analyzed. The PI naïve and PI-experienced populations (other studies) had received antiretroviral therapy prior to Baseline.
Posted
Median
Full Range
log 10 copies per milliliter
Baseline and Weeks 12, 24, 48, 72, 96, 132, and 168
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
OG003
Secondary
Median Plasma HIV-1 RNA at Weeks 180, 240, 300, 360, 420, and 432
Blood samples of participants were collected for the assessment of plasma HIV-1 RNA.
All participants who remained in the study after January 31, 2006. Only those participants contributing data at the indicated time points were analyzed.
Posted
Median
Full Range
log 10 copies per milliliters
Weeks 180, 240, 300, 360, 420, and 432
ID
Title
Description
OG000
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
Units
Counts
Participants
OG000
Secondary
Number of Participants With HIV-1 Disease Progression to CDC Class C, or New CDC Class C or Death, From Baseline
The number of participants with progression of HIV-1 disease were assessed using the CDC classification of HIV-1: class A, asymptomatic or lymphadenopathy; class B: symptomatic, but not AIDS; class C, AIDS. A participant is considered to have had a disease progression if they report a CDC Class C event for the first time, if they report a new CDC Class C event, or if they experience any fatal adverse event during the study.
All participants receiving at least one dose of FPV or FPV/RTV in Study APV30005.
Posted
Number
participants
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
Secondary
Number of Participants Enrolled in Studies APV30001 and APV300002 With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed, excluding recurrences.
All participants receiving FPV or NFV in Studies APV30001 and APV30002.
Posted
Number
participants
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
ID
Title
Description
OG000
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
OG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
OG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
OG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
Secondary
Number of Participants Enrolled in Study APV30003 and Other Studies With the Indicated HIV-associated Conditions
The number of participants with the indicated HIV-associated conditions were assessed.
All participants receiving FPV/RTV in Study APV30005 having previously participated in Study APV30003 or other studies.
Posted
Number
participants
Baseline (Day 1) up to 31 January 2006 (up to Week 264)
ID
Title
Description
OG000
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG001
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG002
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
OG003
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Time Frame
Not provided
Description
Not provided
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
FPV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
33
119
115
119
EG001
NFV Population (APV30001)
FPV +/- RTV + background regimen in participants who had received NFV in APV30001
1
18
16
18
EG002
FPV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
62
221
209
221
EG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
7
54
53
54
EG004
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
20
73
68
73
EG005
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
14
78
73
78
EG006
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
7
104
76
104
EG007
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
13
86
40
86
EG008
Final Analysis Population (APV30005)
FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
15
111
82
111
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anogenital warts
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG0030 affected54 at risk
EG0040 affected73 at risk
EG0050 affected78 at risk
EG0060 affected104 at risk
EG0071 affected86 at risk
EG0080 affected111 at risk
Cellulitis of male external genital organ
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Orchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pneumocystis jiroveci pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0023 affected221 at risk
EG003
Scrotal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Syphilis
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Erysipelas
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Localised infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Meningitis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pneumonia primary atypical
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Superinfection lung
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Abscess limb
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Meningitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Hepatitis C
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Leishmaniasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Perianal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Visceral leishmaniasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Urinary tract infection pseudomonal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Malaria
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG00011 affected119 at risk
EG0010 affected18 at risk
EG00216 affected221 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0024 affected221 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Lung disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Schizoaffective disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Alcoholism
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Conversion disorder
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Depression suicidal
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Mood altered
Psychiatric disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Liver function test abnormal
Investigations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0025 affected221 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Feeling hot
General disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Malaise
General disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Gastrointestinal injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Jaw fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Anastomotic leak
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Collapse of lung
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Laryngeal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Penis carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Paralysis
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Convulsion
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Myoclonus
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Syncope
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Fibrocystic breast disease
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Breast enlargement
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Anal stenosis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Urethral disorder
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Rhabdomyolysis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Arteriosclerosis
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Pterygium
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0021 affected221 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Hyperthyroidism
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Thyroiditis
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00051 affected119 at risk
EG0015 affected18 at risk
EG002131 affected221 at risk
EG00315 affected54 at risk
EG00427 affected73 at risk
EG00537 affected78 at risk
EG00616 affected104 at risk
EG00714 affected86 at risk
EG00814 affected111 at risk
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00047 affected119 at risk
EG0012 affected18 at risk
EG002100 affected221 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG00042 affected119 at risk
EG0014 affected18 at risk
EG00269 affected221 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG00039 affected119 at risk
EG00110 affected18 at risk
EG00248 affected221 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG00035 affected119 at risk
EG0012 affected18 at risk
EG00241 affected221 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG00034 affected119 at risk
EG0013 affected18 at risk
EG00259 affected221 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00024 affected119 at risk
EG0010 affected18 at risk
EG00256 affected221 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG00022 affected119 at risk
EG0011 affected18 at risk
EG00254 affected221 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00020 affected119 at risk
EG0012 affected18 at risk
EG00253 affected221 at risk
EG003
Pyrexia
General disorders
MedDRA
Systematic Assessment
EG00019 affected119 at risk
EG0010 affected18 at risk
EG00230 affected221 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Systematic Assessment
EG00018 affected119 at risk
EG0010 affected18 at risk
EG00230 affected221 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG00016 affected119 at risk
EG0012 affected18 at risk
EG00223 affected221 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG00015 affected119 at risk
EG0010 affected18 at risk
EG00240 affected221 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Systematic Assessment
EG00015 affected119 at risk
EG0010 affected18 at risk
EG00232 affected221 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00014 affected119 at risk
EG0010 affected18 at risk
EG00229 affected221 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00014 affected119 at risk
EG0010 affected18 at risk
EG00217 affected221 at risk
EG003
Pharyngolaryngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG00014 affected119 at risk
EG0011 affected18 at risk
EG00218 affected221 at risk
EG003
Anogenital warts
Infections and infestations
MedDRA
Systematic Assessment
EG00013 affected119 at risk
EG0010 affected18 at risk
EG0025 affected221 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG00013 affected119 at risk
EG0012 affected18 at risk
EG00225 affected221 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Systematic Assessment
EG00013 affected119 at risk
EG0012 affected18 at risk
EG00214 affected221 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG00013 affected119 at risk
EG0010 affected18 at risk
EG00237 affected221 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA
Systematic Assessment
EG00012 affected119 at risk
EG0010 affected18 at risk
EG00230 affected221 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG00011 affected119 at risk
EG0012 affected18 at risk
EG00237 affected221 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG00010 affected119 at risk
EG0010 affected18 at risk
EG00232 affected221 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG00010 affected119 at risk
EG0012 affected18 at risk
EG00214 affected221 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG00010 affected119 at risk
EG0011 affected18 at risk
EG00218 affected221 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0009 affected119 at risk
EG0010 affected18 at risk
EG0027 affected221 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Systematic Assessment
EG0008 affected119 at risk
EG0010 affected18 at risk
EG00221 affected221 at risk
EG003
Asthenia
General disorders
MedDRA
Systematic Assessment
EG0008 affected119 at risk
EG0011 affected18 at risk
EG00211 affected221 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0008 affected119 at risk
EG0010 affected18 at risk
EG00220 affected221 at risk
EG003
Oedema peripheral
General disorders
MedDRA
Systematic Assessment
EG0008 affected119 at risk
EG0010 affected18 at risk
EG00210 affected221 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0008 affected119 at risk
EG0010 affected18 at risk
EG00212 affected221 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0010 affected18 at risk
EG00220 affected221 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0010 affected18 at risk
EG0029 affected221 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0011 affected18 at risk
EG00216 affected221 at risk
EG003
Lipodystrophy acquired
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0010 affected18 at risk
EG0029 affected221 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0010 affected18 at risk
EG00211 affected221 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0007 affected119 at risk
EG0010 affected18 at risk
EG0022 affected221 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0010 affected18 at risk
EG0024 affected221 at risk
EG003
Dermititis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0010 affected18 at risk
EG0026 affected221 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0010 affected18 at risk
EG00218 affected221 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0011 affected18 at risk
EG0028 affected221 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0011 affected18 at risk
EG00210 affected221 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0006 affected119 at risk
EG0010 affected18 at risk
EG00211 affected221 at risk
EG003
Dental caries
General disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0012 affected18 at risk
EG0021 affected221 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0012 affected18 at risk
EG0022 affected221 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0012 affected18 at risk
EG0021 affected221 at risk
EG003
Abscess limb
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Aphthous stomatitis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0011 affected18 at risk
EG0026 affected221 at risk
EG003
Bronchopneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Burns second degree
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0011 affected18 at risk
EG0024 affected221 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0011 affected18 at risk
EG00214 affected221 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0011 affected18 at risk
EG0028 affected221 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0011 affected18 at risk
EG0025 affected221 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0011 affected18 at risk
EG0022 affected221 at risk
EG003
Folliculitis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0011 affected18 at risk
EG00214 affected221 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0011 affected18 at risk
EG0022 affected221 at risk
EG003
Hot flush
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0024 affected221 at risk
EG003
Joint sprain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0011 affected18 at risk
EG0024 affected221 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0011 affected18 at risk
EG00216 affected221 at risk
EG003
Parasitic infection intestinal
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Pelvic inflammatory disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0011 affected18 at risk
EG0023 affected221 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0022 affected221 at risk
EG003
Torticollis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Vaginal candidiasis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0026 affected221 at risk
EG003
Vision blurred
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0025 affected221 at risk
EG003
Vulvovaginitis trichomonal
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0011 affected18 at risk
EG0021 affected221 at risk
EG003
Weight decreased
Investigations
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0011 affected18 at risk
EG00218 affected221 at risk
EG003
Chest pain
General disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG00219 affected221 at risk
EG003
Paraesthesia oral
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG00219 affected221 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0010 affected18 at risk
EG00218 affected221 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG00217 affected221 at risk
EG003
Anorexia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG00215 affected221 at risk
EG003
Hypoasthesia
Nervous system disorders
MedDRA
Systematic Assessment
EG0003 affected119 at risk
EG0010 affected18 at risk
EG00214 affected221 at risk
EG003
Sexual transmission of infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0011 affected18 at risk
EG0020 affected221 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG00214 affected221 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG00213 affected221 at risk
EG003
Lipase increased
Investigations
MedDRA
Systematic Assessment
EG0003 affected119 at risk
EG0010 affected18 at risk
EG00213 affected221 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0010 affected18 at risk
EG00213 affected221 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG00213 affected221 at risk
EG003
Hemorrhoids
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0003 affected119 at risk
EG0010 affected18 at risk
EG00212 affected221 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG00212 affected221 at risk
EG003
Seasonal allergy
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG00212 affected221 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0004 affected119 at risk
EG0010 affected18 at risk
EG00210 affected221 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0027 affected221 at risk
EG003
Ear infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0020 affected221 at risk
EG003
Syphilis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG0025 affected221 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG0026 affected221 at risk
EG003
Viral infection
Infections and infestations
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0027 affected221 at risk
EG003
Skin papilloma
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0025 affected221 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0003 affected119 at risk
EG0010 affected18 at risk
EG0029 affected221 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0001 affected119 at risk
EG0010 affected18 at risk
EG0024 affected221 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0025 affected221 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0026 affected221 at risk
EG003
Influenza like illness
General disorders
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0026 affected221 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA
Systematic Assessment
EG0005 affected119 at risk
EG0010 affected18 at risk
EG0029 affected221 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected119 at risk
EG0010 affected18 at risk
EG0024 affected221 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected119 at risk
EG0010 affected18 at risk
EG0027 affected221 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
GSK Response Center
ViiV Healthcare
866-435-7343
ID
Term
D007239
Infections
D000163
Acquired Immunodeficiency Syndrome
Ancestor Terms
ID
Term
D015658
HIV Infections
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D015229
Sexually Transmitted Diseases, Viral
D012749
Sexually Transmitted Diseases
D016180
Lentivirus Infections
D012192
Retroviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012897
Slow Virus Diseases
D000091662
Genital Diseases
D000091642
Urogenital Diseases
D007153
Immunologic Deficiency Syndromes
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C426859
fosamprenavir
D019438
Ritonavir
Ancestor Terms
ID
Term
D013844
Thiazoles
D013457
Sulfur Compounds
D009930
Organic Chemicals
D001393
Azoles
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
14 subjects
FG0054 subjects
FG00611 subjects
FG0074 subjects
FG0080 subjects
0 subjects
FG0052 subjects
FG0061 subjects
FG0072 subjects
FG0080 subjects
7 subjects
FG0059 subjects
FG0062 subjects
FG00724 subjects
FG0080 subjects
6 subjects
FG0053 subjects
FG0064 subjects
FG0075 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
1 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0055 subjects
FG0063 subjects
FG0074 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0053 subjects
FG0066 subjects
FG0072 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0062 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG00630 subjects
FG0071 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00890 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00821 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0085 subjects
Insufficient Viral Load Response
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0086 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0084 subjects
Tuberculosis
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Participant Moved to Another Country
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Poor Adherence
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
36.2
(26 to 63)
BG00441.9(27 to 58)
BG00542.3(24 to 71)
BG00639.3(21 to 75)
BG00740.2(19 to 60)
BG00838.7(17 to 75)
63
BG00323
BG0049
BG00512
BG00624
BG00722
BG008198
Male
BG00083
BG0019
BG002158
BG00331
BG00464
BG00566
BG00680
BG00764
BG008555
109
BG00314
BG00459
BG00556
BG00644
BG00777
BG008394
Black
Title
Measurements
BG00035
BG0016
BG00286
BG00334
BG00410
BG00514
BG00634
BG0077
BG008226
Asian
Title
Measurements
BG0001
BG0010
BG0024
BG0030
BG0041
BG0051
BG0061
BG0070
BG0088
American Hispanic
Title
Measurements
BG00049
BG00111
BG00216
BG0032
BG0043
BG0057
BG00623
BG0072
BG008113
Other: Race Not Specified
Title
Measurements
BG0000
BG0010
BG0026
BG0034
BG0040
BG0050
BG0062
BG0070
BG00812
16
BG002124
BG00313
BG00426
BG00530
BG00676
BG00729
BG008395
Symptomatic, not AIDS
Title
Measurements
BG00017
BG0011
BG00248
BG00323
BG00421
BG00524
BG00623
BG00718
BG008175
Acquired Immune Deficiency Syndrome (AIDS)
Title
Measurements
BG00021
BG0011
BG00249
BG00318
BG00426
BG00524
BG0065
BG00739
BG008183
54
OG00473
OG00578
OG006104
OG00786
52
OG00472
OG00575
OG00695
OG00768
111
Title
Denominators
Categories
Title
Measurements
OG00095
OG003
NFV Population (APV30002)
FPV +/- RTV + background regimen in participants who had received NFV in APV30002
OG004
FPV/RTV QD Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
OG005
FPV/RTV BID Population (APV30003)
FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
OG006
PI-Naïve Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
OG007
PI-Experienced Population (Other Studies)
FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
Units
Counts
Participants
OG00092
OG00114
OG002159
OG00338
OG00461
OG00565
OG00677
OG00759
Title
Denominators
Categories
Tri.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
Title
Measurements
OG00010(-34 to 42)
OG001-41(-63 to -20)
OG00251(14 to 118)
OG00320(-19 to 57)
OG0049(-25 to 44)
OG00514(-69 to 66)
OG0065(-27 to 58)
OG007-54(-96 to -12)
Tri.; W 96, n=92, 13, 132 36, 47, 52, 67, 44
Title
Measurements
OG0009(-26 to 43)
OG001-48(-101 to 8)
OG00247(10 to 101)
OG003
Tri.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
Title
Measurements
OG00015(-24 to 59)
OG001-33(-77 to 0)
OG00243(2 to 121)
OG003
Tri.; W 132, n=82, 12, 128, 32, 40, 44, 61, 40
Title
Measurements
OG0002(-27 to 46)
OG001-2(-66 to 6)
OG00247(-0 to 101)
OG003
Tri.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
Title
Measurements
OG0003(-27 to 66)
OG001-12(-58 to 25)
OG00227(-19 to 86)
OG003
Tri.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
Title
Measurements
OG0008(-38 to 43)
OG001-41(-89 to 7)
OG00237(4 to 87)
OG003
Tri.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
Title
Measurements
OG0002(-26 to 44)
OG001-36(-88 to -14)
OG00243(8 to 87)
OG003
Tri.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
Title
Measurements
OG0007(-35 to 49)
OG001NA(NA to NA)No participants were analyzed in this arm at this time point.
OG00239(4 to 97)
OG003
Chol.; W 48, n=54, 14, 159, 38, 61, 65, 77, 59
Title
Measurements
OG00052(23 to 70)
OG0013(-32 to 13)
OG00253(26 to 77)
OG003
Chol.; W 96, n=92, 13, 132, 36, 47, 52, 67, 44
Title
Measurements
OG00039(19 to 58)
OG001-3(-16 to 25)
OG00246(21 to 68)
OG003
Chol.; W 120, n=84, 14, 137, 33, 45, 49, 61, 40
Title
Measurements
OG00042(22 to 64)
OG001-9(-17 to 9)
OG00250(23 to 73)
OG003
Chol.; W 132, n=82, 13, 128, 32, 40, 44, 61, 40
Title
Measurements
OG00043(22 to 72)
OG00114(-23 to 32)
OG00247(18 to 82)
OG003
Chol.; W 168, n=71, 14, 123, 31, 31, 40, 20, 33
Title
Measurements
OG00056(28 to 78)
OG0016(-18 to 38)
OG00247(18 to 76)
OG003
Chol.; W 180, n=73, 12, 114, 30, 33, 38, 61, 40
Title
Measurements
OG00054(22 to 73)
OG001-4(-16 to 28)
OG00253(24 to 78)
OG003
Chol.; W 204, n=73, 12, 113, 23, 20, 26, 61, 40
Title
Measurements
OG00052(18 to 76)
OG0015(-32 to 22)
OG00253(22 to 80)
OG003
Chol.; W 216, n=76, 0, 111, 2, 5, 11, 61, 40
Title
Measurements
OG00052(25 to 79)
OG001NA(NA to NA)No participants were analyzed in this arm at this time point.