Efficacy and Safety of Oral Regimens for the Treatment of... | NCT02202980 | Trialant
NCT02202980
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Nov 16, 2018Actual
Enrollment
273Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C
Interventions
LDV/SOF
RBV
SOF/VEL
VOX
Countries
New Zealand
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT02202980
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-337-1468
Secondary IDs
Not provided
Brief Title
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Official Title
A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
Acronym
LEPTON
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 4, 2014Actual
Primary Completion Date
Mar 16, 2016Actual
Completion Date
May 9, 2016Actual
First Submitted Date
Jul 25, 2014
First Submission Date that Met QC Criteria
Jul 25, 2014
First Posted Date
Jul 29, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 15, 2017
Results First Submitted that Met QC Criteria
Nov 6, 2017
Results First Posted Date
Nov 17, 2017Actual
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
Oct 19, 2018
Last Update Posted Date
Nov 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis C
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
273Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Experimental
Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.
Drug: LDV/SOF
Drug: RBV
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
Experimental
Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.
Drug: LDV/SOF
Drug: RBV
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Experimental
Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.
Drug: LDV/SOF
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
Experimental
Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.
Drug: LDV/SOF
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LDV/SOF
Drug
90/400 mg FDC tablet administered orally once daily
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 24 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4 and 24
Percentage of Participants With Virologic Failure
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Willing and able to provide written informed consent
Chronic HCV infection
Cirrhosis determination (liver biopsy may be required)
Screening laboratory values within specified limits
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Specific genotype, prior medical history, or concurrent disease as required by the specific study group
Key Exclusion Criteria:
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Pregnant or nursing female, or male with pregnant female partner
Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
Use of any prohibited concomitant medications
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Auckland
New Zealand
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A
Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.
Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) + ribavirin (RBV) (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12)
FG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
FG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
FG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
FG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
FG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Voxilaprevir (VOX) 100 mg with food on Day 1, followed by sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
FG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
FG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
FG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
FG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
FG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
FG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in nonstructural protein (NS3/4A) protease inhibitor (PI)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
FG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in direct-acting antiviral (DAA)-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
FG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00014 subjects
FG00126 subjects
FG00227 subjects
FG00332 subjects
FG00413 subjects
FG00515 subjects
FG00615 subjects
FG00715 subjects
FG00818 subjects
FG00917 subjects
FG01019 subjects
FG01128 subjects
FG01230 subjects
FG0134 subjects
COMPLETED
FG00013 subjects
FG00124 subjects
FG00217 subjects
FG00328 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG00210 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0027 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
BG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
OG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 24 weeks plus 30 days
Description
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
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
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA Version 19.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA Version 19.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Clinical Trial Disclosures
Gilead Sciences
ClinicalTrialDisclosures@gilead.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D019698
Hepatitis C, Chronic
Ancestor Terms
ID
Term
D006526
Hepatitis C
D000086982
Blood-Borne Infections
D003141
Communicable Diseases
D007239
Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C000595958
ledipasvir, sofosbuvir drug combination
C000611331
sofosbuvir-velpatasvir drug combination
C000619503
voxilaprevir
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Parallel 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
Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.
Drug: LDV/SOF
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
Experimental
Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.
Drug: LDV/SOF
Drug: RBV
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Experimental
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
Experimental
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
Experimental
Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
Experimental
Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
Experimental
Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
Experimental
Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
Experimental
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
Experimental
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.
Drug: SOF/VEL
Drug: VOX
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
Experimental
Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.
Drug: SOF/VEL
Drug: VOX
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Harvoni®
GS-5885/GS-7977
RBV
Drug
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
SOF/VEL
Drug
400/100 mg FDC tablet administered orally once daily
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
Epclusa®
GS-7977/GS-5816
VOX
Drug
100 mg tablet administered orally once daily with food
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
GS-9857
Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Up to Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
Christchurch
New Zealand
Result
Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.
7 subjects
FG00514 subjects
FG0064 subjects
FG00712 subjects
FG00814 subjects
FG00917 subjects
FG01019 subjects
FG01125 subjects
FG01219 subjects
FG0134 subjects
6 subjects
FG0051 subjects
FG00611 subjects
FG0073 subjects
FG0084 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG01211 subjects
FG0130 subjects
0 subjects
FG0043 subjects
FG0051 subjects
FG00611 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0113 subjects
FG01210 subjects
FG0130 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0043 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
Withdrew Consent
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
BG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
BG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
BG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
BG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
BG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
BG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
BG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
BG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
BG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
BG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
BG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
BG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
BG014
Total
Total of all reporting groups
14
BG00126
BG00227
BG00332
BG00413
BG00515
BG00615
BG00715
BG00818
BG00917
BG01019
BG01128
BG01230
BG0134
BG014273
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
Between 18 and 65 years
BG00013
BG00124
BG00225
BG00329
BG004
>=65 years
BG0001
BG0012
BG0022
BG0033
BG004
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0019
BG0028
BG00312
BG0041
BG0058
BG0066
BG0074
BG0088
BG0093
BG0104
BG0119
BG0126
BG0130
BG01482
Male
BG00010
BG00117
BG00219
BG00320
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0061
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0141
Not Hispanic or Latino
BG00014
BG00126
BG00227
BG00332
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00010
BG00124
BG00221
BG00326
BG00412
BG00514
BG00612
BG00714
BG00812
BG00916
BG01018
BG01124
BG01227
BG0133
BG014233
Asian
Title
Measurements
BG0002
BG0012
BG0025
BG003
Native Hawaiian or Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0021
BG003
Other
Title
Measurements
BG0002
BG0010
BG0020
BG003
HCV genotype
Count of Participants
Participants
Title
Denominators
Categories
Genotype 1a
Title
Measurements
BG0001
BG0010
BG0020
BG00328
BG0040
BG00511
BG00611
BG00714
BG0080
BG00915
BG0100
BG01124
BG01223
BG0130
BG014127
Genotype 1b
Title
Measurements
BG0000
BG0010
BG0020
BG003
Genotype 2
Title
Measurements
BG0007
BG0012
BG00227
BG003
Genotype 2a or 2c
Title
Measurements
BG0000
BG0018
BG0020
BG003
Genotype 2b
Title
Measurements
BG0000
BG00116
BG0020
BG003
Genotype 3
Title
Measurements
BG0002
BG0010
BG0020
BG003
Genotype 3a
Title
Measurements
BG0003
BG0010
BG0020
BG003
Genotype 4
Title
Measurements
BG0000
BG0010
BG0020
BG003
Indeterminate
Title
Measurements
BG0001
BG0010
BG0020
BG003
Cirrhosis Status
Count of Participants
Participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0004
BG0012
BG0020
BG0039
BG00410
BG0050
BG0060
BG00715
BG00818
BG00917
BG01019
BG01111
BG0125
BG0132
BG014112
No
Title
Measurements
BG00010
BG00124
BG00227
BG003
IL28b Status
The CC, CT, and TT alleles are different forms of the IL28b gene.
Count of Participants
Participants
Title
Denominators
Categories
CC
Title
Measurements
BG0007
BG00110
BG00214
BG0036
BG0044
BG0055
BG0065
BG0078
BG00810
BG0096
BG0108
BG0114
BG0126
BG0133
BG01496
CT
Title
Measurements
BG0007
BG00115
BG00210
BG003
TT
Title
Measurements
BG0000
BG0011
BG0023
BG003
HCV RNA Category
Count of Participants
Participants
Title
Denominators
Categories
< 800,000 IU/mL
Title
Measurements
BG0001
BG00111
BG0025
BG0038
BG0044
BG0055
BG0064
BG0074
BG0085
BG0093
BG0103
BG01110
BG0125
BG0130
BG01468
≥ 800,000 IU/mL
Title
Measurements
BG00013
BG00115
BG00222
BG003
Prior HCV Treatment
Count of Participants
Participants
Title
Denominators
Categories
Treatment-Naive
Title
Measurements
BG0000
BG00121
BG00220
BG00317
BG0043
BG00515
BG00615
BG00715
BG00818
BG0090
BG0100
BG0110
BG0120
BG0130
BG014124
Treatment-Experienced
Title
Measurements
BG00014
BG0015
BG0027
BG003
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
OG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
OG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
OG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
OG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
OG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
OG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
OG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
OG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Units
Counts
Participants
OG00014
OG00126
OG00227
OG00332
OG00413
OG00515
OG00615
OG00715
OG00818
OG00917
OG01019
OG01128
OG01230
OG0134
Title
Denominators
Categories
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00196.2(80.4 to 99.9)
OG00274.1(53.7 to 88.9)
OG003100.0(89.1 to 100.0)
OG00476.9(46.2 to 95.0)
OG00593.3(68.1 to 99.8)
OG00626.7(7.8 to 55.1)
OG00786.7(59.5 to 98.3)
OG00883.3(58.6 to 96.4)
OG009100.0(80.5 to 100.0)
OG010100.0(82.4 to 100.0)
OG01189.3(71.8 to 97.7)
OG01266.7(47.2 to 82.7)
OG013100.0(39.8 to 100.0)
Primary
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Posted
Number
percentage of participants
Up to 24 weeks
ID
Title
Description
OG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
OG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
OG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
OG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
OG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
OG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
OG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
OG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
OG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
OG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Units
Counts
Participants
OG00014
OG00126
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.1
OG0010
OG0020
OG003
Secondary
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Posted
Number
95% Confidence Interval
percentage of participants
Posttreatment Weeks 4 and 24
ID
Title
Description
OG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
OG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
OG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
OG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
OG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
OG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
OG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
OG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
OG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
OG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Units
Counts
Participants
OG00014
OG00126
OG00227
OG003
Title
Denominators
Categories
SVR4
Title
Measurements
OG00092.9(66.1 to 99.8)
OG00196.2(80.4 to 99.9)
OG00281.5(61.9 to 93.7)
OG003
Secondary
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
On-treatment virologic failure:
Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
OG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
OG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
OG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
OG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
OG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
OG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
OG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
OG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
OG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Units
Counts
Participants
OG00014
OG00126
OG00227
OG003
Title
Denominators
Categories
Title
Measurements
OG0007.1
OG0010
OG00222.2
OG003
Secondary
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit
Participants in the Full Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)
ID
Title
Description
OG000
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
OG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
OG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
OG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
OG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
OG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
OG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
OG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
OG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
OG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
OG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
OG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
Units
Counts
Participants
OG00014
OG00125
OG00227
OG003
Title
Denominators
Categories
Week 1
ParticipantsOG00014
ParticipantsOG00125
ParticipantsOG00227
ParticipantsOG003
0
14
2
14
12
14
EG001
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
0
26
1
26
15
26
EG002
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
0
27
2
27
21
27
EG003
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
0
32
3
32
24
32
EG004
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
0
13
2
13
11
13
EG005
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
0
15
0
15
12
15
EG006
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
0
15
0
15
13
15
EG007
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
0
15
0
15
10
15
EG008
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
0
18
0
18
15
18
EG009
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
0
17
0
17
15
17
EG010
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
0
19
2
19
14
19
EG011
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
0
28
1
28
21
28
EG012
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
0
30
0
30
23
30
EG013
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
0
4
0
4
3
4
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Meniere's disease
Ear and labyrinth disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Gastroenteritis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pneumonia
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Fall
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Bladder transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Bipolar I disorder
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Confusional state
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Acute kidney injury
Renal and urinary disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Renal colic
Renal and urinary disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0042 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Palpitations
Cardiac disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Deafness
Ear and labyrinth disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Ear pain
Ear and labyrinth disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0072 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Diplopia
Eye disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Vision blurred
Eye disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Visual impairment
Eye disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Vitreous detachment
Eye disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0072 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0112 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Constipation
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0092 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0012 affected26 at risk
EG0021 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0053 affected15 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0084 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0116 affected28 at risk
EG0122 affected30 at risk
EG0132 affected4 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0022 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0092 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Flatulence
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0131 affected4 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0103 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Glossodynia
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0052 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0122 affected30 at risk
EG0130 affected4 at risk
Nausea
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0003 affected14 at risk
EG0014 affected26 at risk
EG0025 affected27 at risk
EG0035 affected32 at risk
EG0041 affected13 at risk
EG0055 affected15 at risk
EG0065 affected15 at risk
EG0073 affected15 at risk
EG0083 affected18 at risk
EG0091 affected17 at risk
EG0107 affected19 at risk
EG0113 affected28 at risk
EG0125 affected30 at risk
EG0131 affected4 at risk
Retching
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Salivary gland enlargement
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Toothache
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Vomiting
Gastrointestinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0012 affected26 at risk
EG0021 affected27 at risk
EG0032 affected32 at risk
EG0041 affected13 at risk
EG0051 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0082 affected18 at risk
EG0091 affected17 at risk
EG0103 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Asthenia
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0092 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Catheter site erythema
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Catheter site pain
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Chills
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Fatigue
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0003 affected14 at risk
EG0016 affected26 at risk
EG0025 affected27 at risk
EG0034 affected32 at risk
EG0042 affected13 at risk
EG0055 affected15 at risk
EG0062 affected15 at risk
EG0072 affected15 at risk
EG0083 affected18 at risk
EG0093 affected17 at risk
EG0102 affected19 at risk
EG0117 affected28 at risk
EG0123 affected30 at risk
EG0131 affected4 at risk
Feeling cold
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Generalised oedema
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Impaired healing
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Malaise
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0122 affected30 at risk
EG0130 affected4 at risk
Peripheral swelling
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0032 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pyrexia
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Thirst
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Vessel puncture site haematoma
General disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Food allergy
Immune system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Bronchitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0041 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Cellulitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Folliculitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Gastroenteritis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0012 affected26 at risk
EG0022 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Gingivitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hordeolum
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Lower respiratory tract infection viral
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Nasopharyngitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Oral candidiasis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Oral herpes
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Otitis media
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Paronychia
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pharyngitis
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Skin infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0004 affected14 at risk
EG0014 affected26 at risk
EG0020 affected27 at risk
EG0037 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0084 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0114 affected28 at risk
EG0121 affected30 at risk
EG0131 affected4 at risk
Urinary tract infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0112 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Viral infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0123 affected30 at risk
EG0130 affected4 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0092 affected17 at risk
EG0102 affected19 at risk
EG0112 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Wound infection
Infections and infestations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Arthropod sting
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Chemical burn of skin
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0092 affected17 at risk
EG0101 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Foreign body in eye
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0082 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0101 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0101 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Neck injury
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Skeletal injury
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Skin abrasion
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Weight decreased
Investigations
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0122 affected30 at risk
EG0130 affected4 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Fluid overload
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Increased appetite
Metabolism and nutrition disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0102 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0022 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0062 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0092 affected17 at risk
EG0100 affected19 at risk
EG0113 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Trigger finger
Musculoskeletal and connective tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Balance disorder
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Cognitive disorder
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Dizziness
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0112 affected28 at risk
EG0122 affected30 at risk
EG0130 affected4 at risk
Dysgeusia
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Encephalopathy
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Head discomfort
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Headache
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0006 affected14 at risk
EG0016 affected26 at risk
EG0027 affected27 at risk
EG0036 affected32 at risk
EG0041 affected13 at risk
EG0056 affected15 at risk
EG0062 affected15 at risk
EG0074 affected15 at risk
EG0086 affected18 at risk
EG0093 affected17 at risk
EG0104 affected19 at risk
EG0115 affected28 at risk
EG0126 affected30 at risk
EG0131 affected4 at risk
Lethargy
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0122 affected30 at risk
EG0130 affected4 at risk
Memory impairment
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Migraine without aura
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Paraesthesia
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Presyncope
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Syncope
Nervous system disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Affect lability
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Depression
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Insomnia
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0011 affected26 at risk
EG0021 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0131 affected4 at risk
Irritability
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Nightmare
Psychiatric disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Dysuria
Renal and urinary disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pollakiuria
Renal and urinary disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0032 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0101 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0031 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0021 affected27 at risk
EG0032 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0112 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Sinus disorder
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0131 affected4 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0011 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0012 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0111 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0071 affected15 at risk
EG0081 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0003 affected14 at risk
EG0013 affected26 at risk
EG0022 affected27 at risk
EG0030 affected32 at risk
EG0042 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0121 affected30 at risk
EG0130 affected4 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0001 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0002 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0041 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0051 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Haematoma
Vascular disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0060 affected15 at risk
EG0070 affected15 at risk
EG0081 affected18 at risk
EG0091 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
Hypertension
Vascular disorders
MedDRA Version 19.0
Systematic Assessment
EG0000 affected14 at risk
EG0010 affected26 at risk
EG0020 affected27 at risk
EG0030 affected32 at risk
EG0040 affected13 at risk
EG0050 affected15 at risk
EG0061 affected15 at risk
EG0070 affected15 at risk
EG0080 affected18 at risk
EG0090 affected17 at risk
EG0100 affected19 at risk
EG0110 affected28 at risk
EG0120 affected30 at risk
EG0130 affected4 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
The study has been completed at all study sites for at least 2 years