Efficacy of a 12-Week Regimen of Telaprevir, Pegylated In... | NCT01459913

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Experimental	Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.	Drug: Telaprevir Drug: Pegylated Interferon Alfa-2a Drug: Ribavirin
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Experimental	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.	Drug: Telaprevir Drug: Pegylated Interferon Alfa-2a Drug: Ribavirin
Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)	Experimental	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telaprevir	Drug	Tablet	Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)	SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.	12 weeks after last planned dose of study drug (up to Week 36)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)	SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female subjects, 18 to 70 years of age, inclusive
Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
Subjects have IL28B CC genotype determined during screening
Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required

Exclusion Criteria:

Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
Subjects have evidence of hepatic decompensation
Subjects have evidence of cirrhosis
Subjects have diagnosed or suspected hepatocellular carcinoma
Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic

Name	Affiliation	Role
Mark Friedman, M.D.	Vertex Pharmaceuticals Incorporated	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
BG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
BG002	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
BG003	Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
BG004	Total	Total of all reporting groups

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 Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

Full Analysis (FA) Set.

Posted

Number

percentage of participants

12 weeks after last planned dose of study drug (up to Week 36)

ID	Title	Description
OG000	Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Units	Counts
Participants	OG000106 OG00152

Title

Denominators

Categories

Title	Measurements
	OG00088.7 OG00196.2

Secondary

Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)

SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set.

Posted

Number

percentage of participants

4 weeks after last planned dose of study drug (up to Week 28)

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set.

Posted

Number

percentage of participants

24 weeks after last planned dose of study drug (up to Week 48)

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)

SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set. Here number of subjects analyzed = subjects who were evaluable for this measure. Subjects who did not have the SVR72 assessment because they discontinued the study due to 'Study Terminated by the Sponsor' are excluded from this analysis.

Posted

Number

percentage of participants

Week 72

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)

Secondary

Percentage of Subjects With Viral Relapse

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set.

Posted

Number

percentage of participants

After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Percentage of Subjects With On-Treatment Virologic Failure

On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.

FA Set.

Posted

Number

percentage of participants

Baseline up to Week 48

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Number of Subjects With Rapid Viral Response (RVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set.

Posted

Number

participants

Week 4

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Number of Subjects With Extended Rapid Viral Response (eRVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.

FA Set.

Posted

Number

participants

Week 4 and Week 12

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
OG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.

Secondary

Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents administered during the course of the study.

Safety set included all subjects who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to Week 48

ID	Title	Description
OG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.	5	106	104	106
EG001	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.	4	52	51	52
EG002	Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.	3	19	19	19
EG003	Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)	Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.	13	62	61	62

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0013 affected52 at risk EG0022 affected19 at risk EG0037 affected62 at risk
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Colitis microscopic	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abscess oral	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment	EG00055 affected106 at risk EG00125 affected52 at risk EG00212 affected19 at risk EG00326 affected62 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment	EG00026 affected106 at risk EG00113 affected52 at risk EG0024 affected19 at risk EG003
Influenza like illness	General disorders	MedDRA 16.1	Systematic Assessment	EG00028 affected106 at risk EG00110 affected52 at risk EG0028 affected19 at risk EG003
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment	EG00014 affected106 at risk EG0018 affected52 at risk EG0023 affected19 at risk EG003
Irritability	General disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected106 at risk EG0017 affected52 at risk EG0022 affected19 at risk EG003
Chills	General disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected106 at risk EG0016 affected52 at risk EG0020 affected19 at risk EG003
Injection site erythema	General disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0014 affected52 at risk EG0020 affected19 at risk EG003
Pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0013 affected52 at risk EG0021 affected19 at risk EG003
Malaise	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Oedema peripheral	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0014 affected52 at risk EG0021 affected19 at risk EG003
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Injection site reaction	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Injection site rash	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Chest discomfort	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0014 affected52 at risk EG0020 affected19 at risk EG003
Injection site pruritus	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Local swelling	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Thirst	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Feeling abnormal	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Injection site bruising	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Enanthema	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Feeling cold	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Feeling hot	General disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Injection site pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Temperature intolerance	General disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00049 affected106 at risk EG00119 affected52 at risk EG00213 affected19 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00019 affected106 at risk EG0016 affected52 at risk EG0026 affected19 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00017 affected106 at risk EG0016 affected52 at risk EG0026 affected19 at risk EG003
Anorectal discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00022 affected106 at risk EG0019 affected52 at risk EG0023 affected19 at risk EG003
Anal pruritus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG00010 affected106 at risk EG0018 affected52 at risk EG0023 affected19 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected106 at risk EG0014 affected52 at risk EG0021 affected19 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0013 affected52 at risk EG0023 affected19 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0014 affected52 at risk EG0020 affected19 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0011 affected52 at risk EG0023 affected19 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Cheilitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Gingival bleeding	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Glossodynia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Oral pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Retching	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Bowel movement irregularity	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Faeces pale	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Gingival pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Glossitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hyperchlorhydria	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Lip dry	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Lip pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Oral discomfort	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Oral disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Perianal erythema	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sensitivity of teeth	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Steatorrhoea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Swollen tongue	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tongue coated	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tongue disorder	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00044 affected106 at risk EG00117 affected52 at risk EG0028 affected19 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00031 affected106 at risk EG00115 affected52 at risk EG0029 affected19 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected106 at risk EG00111 affected52 at risk EG0024 affected19 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG00011 affected106 at risk EG00111 affected52 at risk EG0026 affected19 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0013 affected52 at risk EG0023 affected19 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0012 affected52 at risk EG0023 affected19 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0011 affected52 at risk EG0024 affected19 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0011 affected52 at risk EG0022 affected19 at risk EG003
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0022 affected19 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0022 affected19 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hair texture abnormal	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Onychoclasis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pain of skin	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Purpura	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Rash follicular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Rash vesicular	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Scab	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Skin burning sensation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Skin fragility	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Telangiectasia	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00030 affected106 at risk EG00116 affected52 at risk EG0025 affected19 at risk EG003
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00017 affected106 at risk EG0016 affected52 at risk EG0026 affected19 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG00013 affected106 at risk EG0012 affected52 at risk EG0022 affected19 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0015 affected52 at risk EG0020 affected19 at risk EG003
Migraine	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0013 affected52 at risk EG0021 affected19 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Somnolence	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Lethargy	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Dizziness exertional	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Drooling	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Mental impairment	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Parosmia	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sciatica	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tremor	Nervous system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG00042 affected106 at risk EG00122 affected52 at risk EG00210 affected19 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0014 affected52 at risk EG0024 affected19 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00022 affected106 at risk EG00111 affected52 at risk EG0026 affected19 at risk EG003
Depression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG00012 affected106 at risk EG0018 affected52 at risk EG0024 affected19 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected106 at risk EG0012 affected52 at risk EG0022 affected19 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Mood swings	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Affect lability	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Agitation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Anger	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Mood altered	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Apathy	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Drug dependence	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Emotional disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Initial insomnia	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Nervousness	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Aggression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Disorientation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Libido decreased	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Loss of libido	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Personality disorder	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG00018 affected106 at risk EG00111 affected52 at risk EG0025 affected19 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected106 at risk EG0015 affected52 at risk EG0020 affected19 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0007 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0022 affected19 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Nasal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Nasal dryness	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Nasal inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Paranasal sinus discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0009 affected106 at risk EG0017 affected52 at risk EG0022 affected19 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected106 at risk EG0017 affected52 at risk EG0020 affected19 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0014 affected52 at risk EG0020 affected19 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0012 affected52 at risk EG0021 affected19 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0022 affected19 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0005 affected106 at risk EG0011 affected52 at risk EG0022 affected19 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0013 affected52 at risk EG0021 affected19 at risk EG003
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0013 affected52 at risk EG0020 affected19 at risk EG003
Ear infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Oral herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Cystitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Sinusitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Skin infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Candida infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Dermatitis infected	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Folliculitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Genital herpes	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Gingivitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Herpes pharyngitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Parotitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Rash pustular	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Rhinitis	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Scrotal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tinea cruris	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Tooth infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG00021 affected106 at risk EG0016 affected52 at risk EG0024 affected19 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Vision blurred	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0008 affected106 at risk EG0012 affected52 at risk EG0023 affected19 at risk EG003
Photophobia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0006 affected106 at risk EG0013 affected52 at risk EG0020 affected19 at risk EG003
Dry eye	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eye pruritus	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Ocular hyperaemia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Visual impairment	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Diplopia	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eye irritation	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Eye pain	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Retinal exudates	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Abnormal sensation in eye	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Conjunctivitis	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eyelid oedema	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Ocular discomfort	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Periorbital oedema	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Retinopathy	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Vitreous floaters	Eye disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Weight decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0008 affected106 at risk EG0012 affected52 at risk EG0022 affected19 at risk EG003
Lymphocyte count decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0011 affected52 at risk EG0021 affected19 at risk EG003
Blood uric acid increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Blood pressure increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Platelet count decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0022 affected19 at risk EG003
Amylase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Blood potassium decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Blood thyroid stimulating hormone increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Blood urine present	Investigations	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Transaminases increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
White blood cell count decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Blood calcium decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Blood creatinine increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Body temperature increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Electrocardiogram ST-T change	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Eosinophil count increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Haematocrit decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Haemoglobin increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Lipase increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Liver function test abnormal	Investigations	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Red blood cell count decreased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Respiratory rate increased	Investigations	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0004 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Ear pruritus	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hyperacusis	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Otorrhoea	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pallor	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hot flush	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Haematoma	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Orthostatic hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Peripheral coldness	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Vascular pain	Vascular disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0003 affected106 at risk EG0011 affected52 at risk EG0022 affected19 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Supraventricular extrasystoles	Cardiac disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0002 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0012 affected52 at risk EG0020 affected19 at risk EG003
Amenorrhoea	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Menstrual disorder	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Pruritus genital	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Scrotal erythema	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Scrotal pain	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0014 affected52 at risk EG0020 affected19 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0011 affected52 at risk EG0020 affected19 at risk EG003
Melanocytic naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0021 affected19 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0001 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003
Periportal oedema	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment	EG0000 affected106 at risk EG0010 affected52 at risk EG0020 affected19 at risk EG003

Certain Agreements

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Term
C486464	telaprevir
C100416	peginterferon alfa-2a
D012254	Ribavirin