Open-Labeled Study of PSI-7977 and RBV With and Without P... | NCT01260350 | Trialant
NCT01260350
Sponsor
Gilead Sciences
Status
Completed
Last Update Posted
Nov 17, 2014Estimated
Enrollment
292Actual
Phase
Phase 2
Conditions
Chronic Hepatitis C Infection
Interventions
SOF
RBV
PEG
LDV
GS-9669
LDV/SOF
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
NCT01260350
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P7977-0523
Secondary IDs
ID
Type
Description
Link
Medsafe
Other Identifier
Medsafe TT50-8648 (1133)
Brief Title
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Official Title
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
Acronym
Not provided
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Nov 2014
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
Dec 2010
Primary Completion Date
Oct 2013Actual
Completion Date
Dec 2013Actual
First Submitted Date
Dec 13, 2010
First Submission Date that Met QC Criteria
Dec 13, 2010
First Posted Date
Dec 15, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 7, 2014
Results First Submitted that Met QC Criteria
Nov 7, 2014
Results First Posted Date
Nov 17, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 28, 2014
Certification/Extension First Submitted that Passed QC Review
May 28, 2014
Certification/Extension First Posted Date
Jun 2, 2014Estimated
Last Update Submitted Date
Nov 7, 2014
Last Update Posted Date
Nov 17, 2014Estimated
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
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
Detailed Description
Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).
Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).
Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks.
Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13).
Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15).
Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).
Conditions Module
Conditions
Chronic Hepatitis C Infection
Keywords
PSI-7977
Sofosbuvir
GS-7977
GS-5885
GS-9669
FDC
ribavirin
RBV
Pegylated Interferon
PEG-IFN
Chronic Hepatitis C Infection
HCV
Hepatitis
Genotype 1
Genotype 2
Genotype 3
GT 1
GT 2
GT 3
Hemophilia
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
292Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Experimental
Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: SOF
Drug: RBV
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks.
Drug: SOF
Drug: RBV
Drug: PEG
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks.
Drug: SOF
Drug: RBV
Drug: PEG
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.
Drug: SOF
Drug: RBV
Drug: PEG
Group 5: SOF 12 wk: GT 2 or 3, TN
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SOF
Drug
Sofosbuvir (SOF) tablets administered orally once daily
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Up to 12 weeks plus 30 days
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
Posttreatment Week 12
Percentage of Participants With HCV RNA < LOD at Week 6
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL
Not co-infected with HIV
Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
History of any other clinically significant chronic liver disease
Pregnant or nursing female or male with pregnant female partner
History of significant drug allergy to nucleoside/nucleotide analogs.
Participation in a clinical study within 3 months prior to first dose
Positive result for significant drug use at Screening
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.
Participants were enrolled in a total of 2 study sites in New Zealand. The first participant was screened on 18 November 2010. The last participant observation was on 23 December 2013.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
FG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
FG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
FG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
FG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
FG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
FG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
FG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
FG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
FG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
FG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
FG018
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
FG019
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
FG020
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
FG021
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG0019 subjects
FG00210 subjects
FG00311 subjects
FG00410 subjects
FG00510 subjects
FG00610 subjects
FG00725 subjects
FG00825 subjects
FG00925 subjects
FG01010 subjects
FG0119 subjects
FG01225 subjects
FG01310 subjects
FG01425 subjects
FG01510 subjects
FG0169 subjects
FG01710 subjects
FG0180 subjects
FG01914 subjects
FG02025 subjects
FG0210 subjects
COMPLETED
FG00010 subjects
FG0019 subjects
FG00210 subjects
FG00311 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
BG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
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, Continuous
Mean
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 Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Posted
Number
Percentage of participants
Up to 12 weeks plus 30 days
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 12 weeks plus 30 days.
Description
Adverse events are included up to the last dose date of any study drug + 30 days.
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
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Angina Pectoris
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
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, Inc.
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
D006505
Hepatitis
D006467
Hemophilia A
Ancestor Terms
ID
Term
D008107
Liver Diseases
D004066
Digestive System Diseases
D025861
Blood Coagulation Disorders, Inherited
D001778
Blood Coagulation Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000069474
Sofosbuvir
D012254
Ribavirin
C100416
peginterferon alfa-2a
C586541
ledipasvir
C582393
GS-9669
C000595958
ledipasvir, sofosbuvir drug combination
Ancestor Terms
ID
Term
D014542
Uridine Monophosphate
D014500
Uracil Nucleotides
D011742
Pyrimidine Nucleotides
D011743
Pyrimidines
Browse Leaves
Not provided
Browse Branches
Not provided
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
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.
Drug: SOF
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks.
Drug: SOF
Drug: RBV
Drug: PEG
Group 7: SOF+RBV 12 wk: GT 1, TE
Experimental
Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: SOF
Drug: RBV
Group 8: SOF+RBV 12 wk: GT 1, TN
Experimental
Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: SOF
Drug: RBV
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
Experimental
Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: SOF
Drug: RBV
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.
Drug: SOF
Drug: RBV
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.
Drug: SOF
Drug: RBV
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Experimental
Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Drug: SOF
Drug: RBV
Drug: LDV
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
Experimental
Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Drug: SOF
Drug: RBV
Drug: LDV
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Experimental
Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Drug: SOF
Drug: RBV
Drug: GS-9669
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Experimental
Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Drug: SOF
Drug: RBV
Drug: GS-9669
Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis
Experimental
Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Drug: LDV/SOF
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis
Experimental
Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: RBV
Drug: LDV/SOF
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
Experimental
Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Drug: LDV/SOF
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
Experimental
Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Drug: LDV/SOF
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac
Experimental
Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Drug: RBV
Drug: LDV/SOF
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Experimental
Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.
Drug: RBV
Drug: LDV/SOF
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Experimental
Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Drug: LDV/SOF
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Group 5: SOF 12 wk: GT 2 or 3, TN
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Group 7: SOF+RBV 12 wk: GT 1, TE
Group 8: SOF+RBV 12 wk: GT 1, TN
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
Sovaldi®
GS-7977
PSI-7977
RBV
Drug
Ribavirin (RBV) capsules administered orally in a divided daily dose
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Group 7: SOF+RBV 12 wk: GT 1, TE
Group 8: SOF+RBV 12 wk: GT 1, TN
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
Copegus®
PEG
Drug
Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Pegasys®
LDV
Drug
Ledipasvir (LDV) tablets administered orally once daily
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
GS-5885
GS-9669
Drug
GS-9669 tablets administered orally once daily
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
LDV/SOF
Drug
LDV/SOF fixed-dose combination (FDC) tablet administered once daily
Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Harvoni®
Week 6
Percentage of Participants With HCV RNA < LOD at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Week 8
Percentage of Participants With HCV RNA < LOD at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Week 12
Change From Baseline in HCV RNA at Week 6
Baseline to Week 6
Change From Baseline in HCV RNA at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Baseline to Week 8
Change From Baseline in HCV RNA at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Baseline to Week 12
Percentage of Participants With Virologic Failure
The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.
On-treatment virologic failure was defined as:
Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),
Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)
Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.
Up to Posttreatment Week 24
Christchurch
New Zealand
Result
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.
10 subjects
FG00510 subjects
FG00610 subjects
FG00725 subjects
FG00824 subjects
FG00925 subjects
FG01010 subjects
FG0119 subjects
FG01225 subjects
FG01310 subjects
FG01425 subjects
FG01510 subjects
FG0169 subjects
FG0179 subjects
FG0180 subjects
FG01914 subjects
FG02022 subjects
FG0210 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0203 subjects
FG0210 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0171 subjects
FG0180 subjects
FG0190 subjects
FG0203 subjects
FG0210 subjects
Did Not Complete Follow-up 12 Visit
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
FG0180 subjects
FG0190 subjects
FG0200 subjects
FG0210 subjects
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
BG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
BG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
BG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
BG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
BG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
BG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
BG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
BG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
BG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
BG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
BG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
BG020
Total
Total of all reporting groups
10
BG0019
BG00210
BG00311
BG00410
BG00510
BG00610
BG00725
BG00825
BG00925
BG01010
BG0119
BG01225
BG01310
BG01425
BG01510
BG0169
BG01710
BG01814
BG01925
BG020292
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00047± 6.0
BG00147± 10.2
BG00249± 9.9
BG00346± 6.3
BG00443± 13.5
BG00539± 12.2
BG00648± 10.4
BG00748± 11.4
BG00853± 7.9
BG00948± 9.4
BG01039± 8.9
BG01150± 13.0
BG01245± 9.2
BG01355± 6.0
BG01446± 9.3
BG01561± 4.9
BG01657± 5.2
BG01739± 10.8
BG01854± 13.0
BG01951± 9.0
BG02048± 10.6
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0014
BG0025
BG0032
BG0046
BG0055
BG0063
BG00710
BG0086
BG0098
BG0103
BG0112
BG01217
BG0133
BG01412
BG0150
BG0161
BG0177
BG0182
BG01912
BG020110
Male
BG0008
BG0015
BG0025
BG0039
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0051
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0152
BG0160
BG0170
BG0180
BG0190
BG0203
Not Hispanic or Latino
BG00010
BG0019
BG00210
BG00311
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
White
Title
Measurements
BG0007
BG0014
BG0028
BG0039
BG00410
BG0057
BG0069
BG00720
BG00817
BG00920
BG0109
BG0119
BG01223
BG0139
BG01420
BG0158
BG0169
BG0177
BG01812
BG01922
BG020239
Asian
Title
Measurements
BG0000
BG0010
BG0022
BG003
Native Hawaiian of Other Pacific Islander
Title
Measurements
BG0000
BG0010
BG0020
BG003
American Indian or Alaska Native
Title
Measurements
BG0000
BG0011
BG0020
BG003
Other
Title
Measurements
BG0003
BG0014
BG0020
BG003
Hepatitis C Virus (HCV) RNA
Mean
Standard Deviation
log10 IU/mL
Title
Denominators
Categories
Title
Measurements
BG0006.7± 0.42
BG0016.6± 0.52
BG0026.4± 0.57
BG0036.3± 0.76
BG0045.7± 0.89
BG0056.1± 0.88
BG0066.8± 0.55
BG0076.1± 0.75
BG0086.5± 0.66
BG0096.1± 0.80
BG0106.2± 0.96
BG0116.9± 0.20
BG0125.9± 0.85
BG0137.0± 0.38
BG0146.3± 0.54
BG0156.5± 0.57
BG0166.3± 0.78
BG0176.1± 0.94
BG0186.5± 0.51
BG0196.5± 0.56
BG0206.3± 0.73
HCV RNA Category
Number
participants
Title
Denominators
Categories
< 6 log10 IU/mL
Title
Measurements
BG0001
BG0011
BG0023
BG0033
BG0045
BG0055
BG0061
BG00710
BG0085
BG00912
BG0104
BG0110
BG01211
BG0130
BG0148
BG0152
BG0163
BG0175
BG0182
BG0196
BG02087
≥ 6 log10 IU/mL
Title
Measurements
BG0009
BG0018
BG0027
BG003
HCV Genotype
There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
Number
participants
Title
Denominators
Categories
Genotype 1
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG00610
BG00725
BG0080
BG0090
BG0100
BG0119
BG01225
BG01310
BG01425
BG01510
BG0169
BG0170
BG01814
BG01925
BG020162
Genotype 2
Title
Measurements
BG0004
BG0013
BG0024
BG003
Genotype 3
Title
Measurements
BG0006
BG0016
BG0026
BG003
IL28b Genotype
CC, CT, and TT alleles are different forms of the IL28b gene.
Number
participants
Title
Denominators
Categories
CC
Title
Measurements
BG0005
BG0014
BG0024
BG0034
BG0042
BG0053
BG00610
BG00725
BG0080
BG00913
BG0104
BG0110
BG0129
BG0131
BG0147
BG0154
BG0162
BG0173
BG0184
BG0195
BG020109
CT
Title
Measurements
BG0004
BG0014
BG0024
BG003
TT
Title
Measurements
BG0001
BG0011
BG0022
BG003
Cirrhosis Status
Number
participants
Title
Denominators
Categories
Yes
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG01510
BG0169
BG0170
BG0181
BG0190
BG02020
No
Title
Measurements
BG00010
BG0019
BG00210
BG003
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
OG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG00311
OG00410
OG00510
OG00610
OG00725
OG00825
OG00925
OG01010
OG0119
OG01225
OG01310
OG01425
OG01510
OG0169
OG01710
OG01814
OG01925
Title
Denominators
Categories
Any AE
Title
Measurements
OG00010
OG0019
OG00210
OG00311
OG00410
OG00510
OG00610
OG00725
OG00824
OG00925
OG01010
OG0119
OG01224
OG01310
OG01425
OG0157
OG0168
OG0177
OG01813
OG01922
Drug-related AE
Title
Measurements
OG0008
OG0019
OG00210
OG003
Grade 3 or higher AE
Title
Measurements
OG0000
OG0012
OG0020
OG003
AE leading to drug discontinuation
Title
Measurements
OG0000
OG0010
OG0020
OG003
Serious AE
Title
Measurements
OG0001
OG0010
OG0020
OG003
Secondary
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
Safety Analysis Set
Posted
Number
percentage of participants
Posttreatment Week 12
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
OG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100.0(69.2 to 100.0)
OG001100.0(66.4 to 100.0)
OG002100.0(69.2 to 100.0)
OG003
Secondary
Percentage of Participants With HCV RNA < LOD at Week 6
Safety Analysis Set
Posted
Number
percentage of participants
Week 6
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
OG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003
Secondary
Percentage of Participants With HCV RNA < LOD at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 8
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003
Secondary
Percentage of Participants With HCV RNA < LOD at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG006
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG007
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG008
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG009
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG010
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG011
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG014
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG015
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG016
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000100.0
OG001100.0
OG002100.0
OG003
Secondary
Change From Baseline in HCV RNA at Week 6
Safety Analysis Set
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline to Week 6
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
OG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.52± 0.418
OG001-5.44± 0.519
OG002-5.23± 0.571
OG003
Secondary
Change From Baseline in HCV RNA at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline to Week 8
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.52± 0.418
OG001-5.44± 0.519
OG002-5.23± 0.571
OG003
Secondary
Change From Baseline in HCV RNA at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Participants in the Safety Analysis Set with available data were analyzed.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline to Week 12
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG006
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG007
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG008
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG009
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG010
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG011
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG000-5.52± 0.418
OG001-5.44± 0.519
OG002-5.23± 0.571
OG003
Secondary
Percentage of Participants With Virologic Failure
The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.
On-treatment virologic failure was defined as:
Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment),
Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment)
Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.
Safety Analysis Set
Posted
Number
percentage of participants
Up to Posttreatment Week 24
ID
Title
Description
OG000
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
OG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
OG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
OG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
OG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
OG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
OG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
OG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
OG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
Units
Counts
Participants
OG00010
OG0019
OG00210
OG003
Title
Denominators
Categories
On-treatment virologic failure
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
1
10
10
10
EG001
Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
9
9
9
EG002
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
10
10
10
EG003
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
11
11
11
EG004
Group 5: SOF 12 wk: GT 2 or 3, TN
SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
10
10
10
EG005
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
1
10
10
10
EG006
Group 7: SOF+RBV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
0
10
10
10
EG007
Group 8: SOF+RBV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
1
25
25
25
EG008
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
0
25
24
25
EG009
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
2
25
25
25
EG010
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
10
10
10
EG011
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
0
9
9
9
EG012
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
2
25
24
25
EG013
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
0
10
10
10
EG014
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
0
25
25
25
EG015
Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
0
10
7
10
EG016
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
0
9
8
9
EG017
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
0
10
7
10
EG018
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
2
14
13
14
EG019
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
0
25
22
25
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Diverticulitis Perforation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Emterovesical Fistula
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Cholelithiasis
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Breast Abscess
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Diverticulitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Furuncle
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pyelonephritis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Urethral injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Syncope
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
EG0001 affected10 at risk
EG0013 affected9 at risk
EG0020 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0053 affected10 at risk
EG0062 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0182 affected14 at risk
EG0190 affected25 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0075 affected25 at risk
EG0081 affected25 at risk
EG0092 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0143 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0192 affected25 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Palpitations
Cardiac disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Eustachian tube obstruction
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Blepharitis
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0191 affected25 at risk
Blepharospasm
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Conjunctivitis
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Dry eye
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0022 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Eye inflammation
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Eye irritation
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Eye pain
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Lacrimation increased
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Ocular discomfort
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Photophobia
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pterygium
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vision blurred
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Visual impairment
Eye disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Abdominal pain lower
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Anal fissure
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Anal pruritus
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Aphthous stomatitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0192 affected25 at risk
Change of bowel habit
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Chapped lips
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Cheilitis
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Constipation
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0093 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0192 affected25 at risk
Dental caries
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0022 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0053 affected10 at risk
EG0061 affected10 at risk
EG0076 affected25 at risk
EG0081 affected25 at risk
EG0093 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0144 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0173 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Dry mouth
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0022 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0092 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0191 affected25 at risk
Flatulence
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Frequent bowel movements
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0073 affected25 at risk
EG0082 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0112 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Gingival bleeding
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Gingival disorder
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Gingival ulceration
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Glossodynia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Nausea
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0013 affected9 at risk
EG0024 affected10 at risk
EG0032 affected11 at risk
EG0043 affected10 at risk
EG0052 affected10 at risk
EG0062 affected10 at risk
EG00711 affected25 at risk
EG0085 affected25 at risk
EG0094 affected25 at risk
EG0103 affected10 at risk
EG0113 affected9 at risk
EG0126 affected25 at risk
EG0132 affected10 at risk
EG0149 affected25 at risk
EG0150 affected10 at risk
EG0164 affected9 at risk
EG0171 affected10 at risk
EG0184 affected14 at risk
EG0195 affected25 at risk
Oral pain
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Paraesthesia oral
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Stomatitis haemorrhagic
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Toothache
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Umbilical hernia
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vomiting
Gastrointestinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0081 affected25 at risk
EG0092 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0121 affected25 at risk
EG0131 affected10 at risk
EG0149 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0171 affected10 at risk
EG0181 affected14 at risk
EG0193 affected25 at risk
Application site inflammation
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Asthenia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Axillary pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0042 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Catheter site pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Chest discomfort
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Chest pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Chills
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Crying
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Drug withdrawal syndrome
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Facial pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Fatigue
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected9 at risk
EG0023 affected10 at risk
EG0035 affected11 at risk
EG0043 affected10 at risk
EG0057 affected10 at risk
EG0064 affected10 at risk
EG00712 affected25 at risk
EG00810 affected25 at risk
EG0099 affected25 at risk
EG0101 affected10 at risk
EG0117 affected9 at risk
EG0126 affected25 at risk
EG0135 affected10 at risk
EG0144 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0187 affected14 at risk
EG0196 affected25 at risk
Feeling abnormal
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Feeling cold
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Feeling of body temperature change
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Influenza like illness
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Injection site discomfort
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Injection site erythema
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Injection site inflammation
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Injection site pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Injection site reaction
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Irritability
General disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0034 affected11 at risk
EG0041 affected10 at risk
EG0052 affected10 at risk
EG0061 affected10 at risk
EG0075 affected25 at risk
EG0080 affected25 at risk
EG0093 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0124 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0182 affected14 at risk
EG0193 affected25 at risk
Malaise
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Oedema peripheral
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pyrexia
General disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0055 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Spinal pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Thirst
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vessel puncture site bruise
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vessel puncture site pain
General disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Biliary colic
Hepatobiliary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Drug hypersensitivity
Immune system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Hypersensitivity
Immune system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Cellulitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Conjunctivitis viral
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Folliculitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Furuncle
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Gastroenteritis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Gingivitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Groin abscess
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Herpes simplex
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Herpes zoster
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Hordeolum
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Infective exacerbation of bronchiectasis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Oral herpes
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Otitis externa
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Otitis media
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pharyngitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pilonidal cyst
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Rash pustular
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0074 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rhinitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0062 affected10 at risk
EG0070 affected25 at risk
EG0082 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0122 affected25 at risk
EG0131 affected10 at risk
EG0143 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Sinusitis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Tinea pedis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0042 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0074 affected25 at risk
EG0086 affected25 at risk
EG0093 affected25 at risk
EG0103 affected10 at risk
EG0113 affected9 at risk
EG0129 affected25 at risk
EG0132 affected10 at risk
EG0143 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0172 affected10 at risk
EG0182 affected14 at risk
EG0193 affected25 at risk
Urinary tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0032 affected11 at risk
EG0041 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Viral infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Viral upper respiratory tract infection
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vulvovaginal candidiasis
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vulvovaginitis trichomonal
Infections and infestations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Animal bite
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Animal scratch
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Chest injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0073 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Excoriation
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Laceration
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Limb injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Nerve injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Peroneal nerve injury
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Tooth fracture
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vessel puncture site bruise
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Wound
Injury, poisoning and procedural complications
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Haemoglobin decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Liver function test abnormal
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Weight decreased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Weight increased
Investigations
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Abnormal loss of weight
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0033 affected11 at risk
EG0040 affected10 at risk
EG0055 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0082 affected25 at risk
EG0093 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Food craving
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Increased appetite
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Polydipsia
Metabolism and nutrition disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0092 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0023 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0073 affected25 at risk
EG0080 affected25 at risk
EG0092 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0125 affected25 at risk
EG0132 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0191 affected25 at risk
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Muscle atrophy
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Muscle twitching
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0082 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0013 affected9 at risk
EG0023 affected10 at risk
EG0033 affected11 at risk
EG0041 affected10 at risk
EG0054 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0086 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0113 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Upper extremity mass
Musculoskeletal and connective tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Lipoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Amnesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Balance disorder
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Disturbance in attention
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0192 affected25 at risk
Dizziness
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0004 affected10 at risk
EG0014 affected9 at risk
EG0022 affected10 at risk
EG0033 affected11 at risk
EG0042 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0092 affected25 at risk
EG0100 affected10 at risk
EG0112 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Dizziness postural
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dysgeusia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Head discomfort
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Headache
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0004 affected10 at risk
EG0017 affected9 at risk
EG0029 affected10 at risk
EG0038 affected11 at risk
EG0048 affected10 at risk
EG0056 affected10 at risk
EG0064 affected10 at risk
EG0078 affected25 at risk
EG00811 affected25 at risk
EG0096 affected25 at risk
EG0102 affected10 at risk
EG0116 affected9 at risk
EG01211 affected25 at risk
EG0134 affected10 at risk
EG0148 affected25 at risk
EG0153 affected10 at risk
EG0162 affected9 at risk
EG0174 affected10 at risk
EG0185 affected14 at risk
EG0198 affected25 at risk
Hyperaesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Hypogeusia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Lethargy
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0062 affected10 at risk
EG0073 affected25 at risk
EG0084 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0152 affected10 at risk
EG0162 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0192 affected25 at risk
Memory impairment
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Migraine
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Paraesthesia
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Presyncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Restless legs syndrome
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Somnolence
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Syncope
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0072 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0121 affected25 at risk
EG0131 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Tremor
Nervous system disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Abnormal dreams
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Affect lability
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Anxiety
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0082 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0162 affected9 at risk
EG0172 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Depressed mood
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0032 affected11 at risk
EG0041 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0092 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Depression
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0033 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0092 affected25 at risk
EG0101 affected10 at risk
EG0112 affected9 at risk
EG0124 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0171 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Depressive symptom
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dysphoria
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dysthymic disorder
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Impatience
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Insomnia
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected10 at risk
EG0016 affected9 at risk
EG0025 affected10 at risk
EG0035 affected11 at risk
EG0046 affected10 at risk
EG0051 affected10 at risk
EG0064 affected10 at risk
EG0075 affected25 at risk
EG0083 affected25 at risk
EG0093 affected25 at risk
EG0102 affected10 at risk
EG0114 affected9 at risk
EG0124 affected25 at risk
EG0131 affected10 at risk
EG0143 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0172 affected10 at risk
EG0183 affected14 at risk
EG0196 affected25 at risk
Libido decreased
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Loss of libido
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Mood altered
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0022 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0082 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Mood swings
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Panic attack
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Sleep disorder
Psychiatric disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Chromaturia
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0191 affected25 at risk
Dysuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0073 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Haematuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Micturition urgency
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Nocturia
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pollakiuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Polyuria
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Urine odour abnormal
Renal and urinary disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Amenorrhoea
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Breast pain
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Cervical dysplasia
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Erectile dysfunction
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Menstruation delayed
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Metrorrhagia
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0113 affected9 at risk
EG0123 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0034 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0094 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0124 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0182 affected14 at risk
EG0191 affected25 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected9 at risk
EG0022 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0002 affected10 at risk
EG0011 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0042 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0082 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0113 affected9 at risk
EG0122 affected25 at risk
EG0131 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0193 affected25 at risk
Pharyngeal erythema
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Sneezing
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Upper respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Acne
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0025 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Blister
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0121 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Catheter site bruise
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Cold sweat
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0011 affected9 at risk
EG0024 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0084 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0125 affected25 at risk
EG0130 affected10 at risk
EG0142 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Eczema
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0012 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Macule
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Onychoclasis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0101 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0013 affected9 at risk
EG0023 affected10 at risk
EG0032 affected11 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
EG0062 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0092 affected25 at risk
EG0102 affected10 at risk
EG0110 affected9 at risk
EG0122 affected25 at risk
EG0130 affected10 at risk
EG0143 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0003 affected10 at risk
EG0013 affected9 at risk
EG0023 affected10 at risk
EG0033 affected11 at risk
EG0041 affected10 at risk
EG0056 affected10 at risk
EG0063 affected10 at risk
EG0074 affected25 at risk
EG0086 affected25 at risk
EG0091 affected25 at risk
EG0101 affected10 at risk
EG0111 affected9 at risk
EG0124 affected25 at risk
EG0131 affected10 at risk
EG0145 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0181 affected14 at risk
EG0193 affected25 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0091 affected25 at risk
EG0100 affected10 at risk
EG0111 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0141 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rash papular
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0081 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin discolouration
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin fissures
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0112 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0171 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0031 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Urticaria
Skin and subcutaneous tissue disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0021 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Tooth extraction
Surgical and medical procedures
MedDRA (16.0)
Systematic Assessment
EG0001 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0071 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Haematoma
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0061 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 at risk
Hot flush
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0011 affected9 at risk
EG0022 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0161 affected9 at risk
EG0170 affected10 at risk
EG0181 affected14 at risk
EG0190 affected25 at risk
Hypertension
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0130 affected10 at risk
EG0140 affected25 at risk
EG0151 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0191 affected25 at risk
Thrombophlebitis superficial
Vascular disorders
MedDRA (16.0)
Systematic Assessment
EG0000 affected10 at risk
EG0010 affected9 at risk
EG0020 affected10 at risk
EG0030 affected11 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
EG0060 affected10 at risk
EG0070 affected25 at risk
EG0080 affected25 at risk
EG0090 affected25 at risk
EG0100 affected10 at risk
EG0110 affected9 at risk
EG0120 affected25 at risk
EG0131 affected10 at risk
EG0140 affected25 at risk
EG0150 affected10 at risk
EG0160 affected9 at risk
EG0170 affected10 at risk
EG0180 affected14 at risk
EG0190 affected25 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
D006402
Hematologic Diseases
D006425
Hemic and Lymphatic Diseases
D020147
Coagulation Protein Disorders
D006474
Hemorrhagic Disorders
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities