An Observational Study on Dual And Triple Therapies Based... | NCT01447446 | Trialant
NCT01447446
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Mar 30, 2017Actual
Enrollment
4,442Actual
Phase
Not provided
Conditions
Hepatitis C, Chronic
Interventions
Peg-IFN Alfa-2a
Peg-IFN Alfa-2b
Ribavirin
Boceprevir
Telaprevir
Countries
Belgium
Egypt
Estonia
France
Germany
Greece
Hungary
Ireland
Italy
Kuwait
Lebanon
Morocco
North Macedonia
Oman
Pakistan
Portugal
Qatar
Romania
Saudi Arabia
Serbia
Sweden
Switzerland
Syria
Taiwan
Turkey (Türkiye)
United Arab Emirates
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01447446
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MV25599
Secondary IDs
Not provided
Brief Title
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
Official Title
Non-Interventional Cohort Study on the Utilization and Impact of Dual and Triple Therapies Based on Pegylated Interferon for the Treatment of Chronic Hepatitis C
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Dec 2016
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
Sep 2011
Primary Completion Date
Jul 2015Actual
Completion Date
Jul 2015Actual
First Submitted Date
Oct 4, 2011
First Submission Date that Met QC Criteria
Oct 5, 2011
First Posted Date
Oct 6, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 27, 2016
Results First Submitted that Met QC Criteria
Feb 10, 2017
Results First Posted Date
Mar 30, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 10, 2017
Last Update Posted Date
Mar 30, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This prospective, multicenter, observational cohort study will evaluate the efficacy and safety of pegylated interferon alfa (peginterferon alfa) (e.g. Pegasys) plus ribavirin and treatment regimens containing direct-acting antivirals in participants with chronic hepatitis C who are treatment-naïve or treatment-experienced and HIV HCV co-infected. Data will be collected from participants receiving treatment according to current Summary of Product Characteristics (SPC) and local labeling for the duration of their treatment and a 24-week follow-up.
Detailed Description
Not provided
Conditions Module
Conditions
Hepatitis C, Chronic
Keywords
Not provided
Design Module
Study Type
Observational
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
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
4,442Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with chronic hepatitis C (CHC) receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed up for the duration of their treatment and for up to 24 weeks after therapy.
Drug: Peg-IFN Alfa-2a
Drug: Ribavirin
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Peg-IFN Alfa-2a
Drug
Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
24 weeks after end of treatment (up to 118 weeks)
Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
12 weeks after end of treatment (up to 118 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Adult (according to local legislation) participants
Chronic hepatitis C (HCV)
Naive or treatment experienced, HIV-HCV co-infected or HCV mono-infected
Receiving treatment for HCV with pegylated interferons plus ribavirin or regimens containing direct-acting antivirals (DAA) according to standard of care and in line with current SPC/local labeling
Exclusion Criteria:
Contraindications according to SPC/local labeling
Treatment started >4 weeks before entering study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Chronic hepatitis C (CHC) participants (naïve or treatment experienced, including HIV HCV co-infected) receiving combination therapy with pegylated interferons plus ribavirin or treatment regimens containing direct-acting antivirals.
Sampling Method
Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Antwerp
2018
Belgium
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
A total of 4442 participants were enrolled in the study, one participant had double enrollment. Out of 4442 participants, analyses were restricted to only core population, which included 4100 participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
Virological Relapse After End of Treatment
Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
Up to 24 weeks after EOT (up to 118 weeks)
Virological Breakthrough
Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Up to EOT (up to 118 weeks)
Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Up to first 12 weeks of treatment
Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
Up to 12 weeks
Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Up to 98 weeks
Duration of Overall Treatment
Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Up to 118 weeks
Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
Up to 118 weeks
Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Participants who prolonged the treatment period from 72 weeks were not reported.
Up to 72 weeks of treatment
Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Up to 72 weeks of treatment
Percentage of Participants With Concomitant Medical Condition at Baseline
Baseline
Percentage of Participants With Adverse Events (AE)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
FG0002312 subjectsStarted means participants who started treatment and included in core population.
FG001496 subjects
FG002292 subjects
FG00393 subjects
FG004821 subjects
FG00586 subjects
COMPLETED
FG0001590 subjectsCompleted means the participants who completed the 24- weeks of follow-up period.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
BG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0002312
BG001496
BG002292
BG00393
BG004821
BG00586
BG0064100
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
Less Than or Equal to (<=) 45 Years
Title
Measurements
BG000987
BG001178
BG00273
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000910
BG001250
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24)
SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 24 weeks post completion of the treatment period.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
24 weeks after end of treatment (up to 118 weeks)
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12)
SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be <=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 weeks post completion of the treatment period.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
12 weeks after end of treatment (up to 118 weeks)
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Secondary
Virological Response at Various on Treatment Time Points and End of Treatment (EOT)
Virological response (VR) for dual therapy participants is defined as HCV RNA <50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) <=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) <=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ >50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection <=50 IU/mL (UVR). Results of HCV RNA tests with an LLD >50 IU/mL were considered as non-response for triple therapy participants.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
Week 4, 12 and End of treatment (EOT) (up to 96 weeks)
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Secondary
Virological Relapse After End of Treatment
Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA >=50 IU/mL).
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
Up to 24 weeks after EOT (up to 118 weeks)
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Virological Breakthrough
Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by >=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
Up to EOT (up to 118 weeks)
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions
SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to [<=] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be <=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection <= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
95% Confidence Interval
percentage of participants
Up to first 12 weeks of treatment
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks
Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported.
The data for all of the above mentioned virological responses were not collected and was not analyzed.
Posted
Up to 12 weeks
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG002
Secondary
Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR)
Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG002
Secondary
Duration of Overall Treatment
Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Mean
Standard Deviation
Weeks
Up to 118 weeks
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC)
The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value.
Posted
Up to 118 weeks
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV)
Participants who prolonged the treatment period from 72 weeks were not reported.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
percentage of participants
Up to 72 weeks of treatment
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA)
Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA).
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Percentage of Participants With Concomitant Medical Condition at Baseline
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
percentage of participants
Baseline
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Secondary
Percentage of Participants With Adverse Events (AE)
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy).
Posted
Number
percentage of participants
Up to 118 weeks
ID
Title
Description
OG000
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Time Frame
Up to 118 weeks
Description
An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment.
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
Dual Therapy: Peg-IFN Alfa-2a + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
148
2,312
1,225
2,312
EG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
4
86
72
86
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acquired haemophilia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG0030 affected93 at risk
EG004
Agranulocytosis
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG00025 affected2,312 at risk
EG0012 affected496 at risk
EG0029 affected292 at risk
EG003
Aplasia pure red cell
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Bone marrow failure
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Haemolysis
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Haemolytic anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Immune thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0022 affected292 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG00012 affected2,312 at risk
EG0011 affected496 at risk
EG0024 affected292 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected2,312 at risk
EG0012 affected496 at risk
EG0022 affected292 at risk
EG003
Thrombotic thrombocytopenic purpura
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Angina unstable
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Bundle branch block left
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cardiovascular insufficiency
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0021 affected292 at risk
EG003
Coronary artery occlusion
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Palpitations
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cerebrovascular arteriovenous malformation
Congenital, familial and genetic disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Deafness
Ear and labyrinth disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Blindness unilateral
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Eye oedema
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Retinal detachment
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Retinal vein thrombosis
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Retinopathy
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Visual acuity reduced
Eye disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Alcoholic pancreatitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Anal fissure
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0011 affected496 at risk
EG0021 affected292 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Gastric ulcer perforation
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Oesophageal varices haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Reflux gastritis
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Varices oesophageal
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0022 affected292 at risk
EG003
Asthenia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Chest discomfort
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Death
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
General physical health deterioration
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Malaise
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Oedema
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Oedema peripheral
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0011 affected496 at risk
EG0021 affected292 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Vascular stent restenosis
General disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Bile duct stone
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatitis acute
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatorenal syndrome
Hepatobiliary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Acinetobacter infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Appendicitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0003 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Arthritis bacterial
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Atypical mycobacterial infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Brain abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cellulitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Dermo-hypodermitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
End stage AIDS
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Endocarditis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Erysipelas
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Extradural abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Hepatitis B
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Infected dermal cyst
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Infectious pleural effusion
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Listeria sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Lung abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Lung infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Meningitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Orchitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Peritonitis bacterial
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Peritonsillar abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG00012 affected2,312 at risk
EG0012 affected496 at risk
EG0021 affected292 at risk
EG003
Pulmonary sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pulmonary tuberculosis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0012 affected496 at risk
EG0021 affected292 at risk
EG003
Septic arthritis staphylococcal
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Septic shock
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Sinusitis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Staphylococcal abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Streptococcal endocarditis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Subcutaneous abscess
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Tracheobronchitis mycoplasmal
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0005 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Urosepsis
Infections and infestations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Craniocerebral injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cystitis radiation
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Head injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0021 affected292 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Multiple injuries
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pneumocephalus
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Skull fractured base
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
VIIIth nerve injury
Injury, poisoning and procedural complications
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Alpha 1 foetoprotein increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Blood pressure increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Blood urea increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Weight decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cachexia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diabetes mellitus inadequate control
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Tetany
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Type 1 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Type 2 diabetes mellitus
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Compartment syndrome
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Muscle haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Neck mass
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Sacroiliitis
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Anogenital warts
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
B-cell lymphoma recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cardiac myxoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Cholangiocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diffuse large B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatic cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatic cancer recurrent
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatocellular carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0007 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Metastases to lung
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Non-hodgkin's lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Oesophageal squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Papillary cystadenoma lymphomatosum
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pituitary tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Carotid artery stenosis
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Cognitive disorder
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Complex partial seizures
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diabetic encephalopathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Diabetic hyperglycaemic coma
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Dysarthria
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Facial paresis
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Hemiplegia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hepatic encephalopathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Loss of consciousness
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Metabolic encephalopathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Occipital neuralgia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Optic neuritis
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Presyncope
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Sensorimotor disorder
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Syncope
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Toxic leukoencephalopathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Wernicke's encephalopathy
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Acute psychosis
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Alcoholism
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Bipolar disorder
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Delirium
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Depression
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0005 affected2,312 at risk
EG0012 affected496 at risk
EG0020 affected292 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Mental disorder
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Persecutory delusion
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Restlessness
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Somatoform disorder
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Calculus ureteric
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Lupus nephritis
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Urethral stenosis
Renal and urinary disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Menometrorrhagia
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Prostatitis
Reproductive system and breast disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Acute pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pulmonary arterial hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Excessive granulation tissue
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0022 affected292 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Toxic skin eruption
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Vascular purpura
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Victim of homicide
Social circumstances
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Polypectomy
Surgical and medical procedures
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0002 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Peripheral venous disease
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Temporal arteritis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Venous thrombosis
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Venous thrombosis limb
Vascular disorders
MedDRA (18.1)
Systematic Assessment
EG0000 affected2,312 at risk
EG0010 affected496 at risk
EG0021 affected292 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG000435 affected2,312 at risk
EG001141 affected496 at risk
EG002112 affected292 at risk
EG00342 affected93 at risk
EG004351 affected821 at risk
EG00543 affected86 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG000258 affected2,312 at risk
EG00164 affected496 at risk
EG00235 affected292 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG000129 affected2,312 at risk
EG00147 affected496 at risk
EG0028 affected292 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (18.1)
Systematic Assessment
EG000138 affected2,312 at risk
EG00126 affected496 at risk
EG00231 affected292 at risk
EG003
Asthenia
General disorders
MedDRA (18.1)
Systematic Assessment
EG000236 affected2,312 at risk
EG00172 affected496 at risk
EG00253 affected292 at risk
EG003
Fatigue
General disorders
MedDRA (18.1)
Systematic Assessment
EG000244 affected2,312 at risk
EG00153 affected496 at risk
EG00268 affected292 at risk
EG003
Influenza like illness
General disorders
MedDRA (18.1)
Systematic Assessment
EG000167 affected2,312 at risk
EG00138 affected496 at risk
EG00231 affected292 at risk
EG003
Pyrexia
General disorders
MedDRA (18.1)
Systematic Assessment
EG000147 affected2,312 at risk
EG00145 affected496 at risk
EG00213 affected292 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG000160 affected2,312 at risk
EG00155 affected496 at risk
EG00237 affected292 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00085 affected2,312 at risk
EG00125 affected496 at risk
EG00224 affected292 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG000121 affected2,312 at risk
EG00140 affected496 at risk
EG00218 affected292 at risk
EG003
Depression
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG00082 affected2,312 at risk
EG00132 affected496 at risk
EG00215 affected292 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (18.1)
Systematic Assessment
EG000101 affected2,312 at risk
EG00147 affected496 at risk
EG00225 affected292 at risk
EG003
Headache
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG000102 affected2,312 at risk
EG00139 affected496 at risk
EG00233 affected292 at risk
EG003
Weight decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00097 affected2,312 at risk
EG00128 affected496 at risk
EG00214 affected292 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00085 affected2,312 at risk
EG00130 affected496 at risk
EG00236 affected292 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00051 affected2,312 at risk
EG00111 affected496 at risk
EG00222 affected292 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00069 affected2,312 at risk
EG00120 affected496 at risk
EG00214 affected292 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00059 affected2,312 at risk
EG0018 affected496 at risk
EG00217 affected292 at risk
EG003
Anal pruritus
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0001 affected2,312 at risk
EG0010 affected496 at risk
EG0020 affected292 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00026 affected2,312 at risk
EG0019 affected496 at risk
EG0028 affected292 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG0009 affected2,312 at risk
EG0011 affected496 at risk
EG0025 affected292 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00032 affected2,312 at risk
EG0012 affected496 at risk
EG00210 affected292 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA (18.1)
Systematic Assessment
EG00021 affected2,312 at risk
EG0013 affected496 at risk
EG0027 affected292 at risk
EG003
Irritability
Psychiatric disorders
MedDRA (18.1)
Systematic Assessment
EG00048 affected2,312 at risk
EG0017 affected496 at risk
EG00210 affected292 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG00013 affected2,312 at risk
EG0015 affected496 at risk
EG00233 affected292 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (18.1)
Systematic Assessment
EG00040 affected2,312 at risk
EG00119 affected496 at risk
EG0029 affected292 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG000103 affected2,312 at risk
EG00123 affected496 at risk
EG00223 affected292 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG00054 affected2,312 at risk
EG00116 affected496 at risk
EG00218 affected292 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (18.1)
Systematic Assessment
EG00010 affected2,312 at risk
EG0014 affected496 at risk
EG0025 affected292 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00045 affected2,312 at risk
EG00119 affected496 at risk
EG00218 affected292 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (18.1)
Systematic Assessment
EG00076 affected2,312 at risk
EG00119 affected496 at risk
EG0028 affected292 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA (18.1)
Systematic Assessment
EG00022 affected2,312 at risk
EG0019 affected496 at risk
EG0021 affected292 at risk
EG003
Neutrophil count increased
Investigations
MedDRA (18.1)
Systematic Assessment
EG0006 affected2,312 at risk
EG0011 affected496 at risk
EG0020 affected292 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
93
OG004821
OG00586
50.5
(40.0 to 61.1)
OG00457.7(54.3 to 61.1)
OG00547.7(36.8 to 58.7)
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Units
Counts
Participants
OG0002312
OG001496
OG002292
OG00393
OG004821
OG00586
Title
Denominators
Categories
Title
Measurements
OG00054.3(52.2 to 56.3)
OG00151.0(46.5 to 55.5)
OG00250.0(44.1 to 55.9)
OG00353.8(43.1 to 64.2)
OG00462.0(58.6 to 65.3)
OG00557.0(45.8 to 67.6)
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Units
Counts
Participants
OG0002079
OG001437
OG002275
OG00388
OG004785
OG00574
Title
Denominators
Categories
Title
Measurements
OG0005.4(4.5 to 6.4)
OG0014.8(3.0 to 7.3)
OG0028.7(5.7 to 12.7)
OG00315.9(9.0 to 25.2)
OG00415.0(12.6 to 17.7)
OG00521.6(12.9 to 32.7)
OG001
Dual Therapy: Peg-IFN Alfa-2b + Ribavirin
Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Units
Counts
Participants
OG000292
OG00193
OG002821
OG00386
Title
Denominators
Categories
Title
Measurements
OG00037.7(32.1 to 43.5)
OG00132.3(22.9 to 42.7)
OG00245.6(42.1 to 49.0)
OG00347.7(36.8 to 58.7)
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.