Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepati... | NCT00336479

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo Comparator	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.	Drug: Ribavirin Drug: Pegylated Interferon Alfa 2a Other: Placebo
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Experimental	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.	Drug: Telaprevir Drug: Ribavirin Drug: Pegylated Interferon Alfa 2a
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week	Experimental	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.	Drug: Telaprevir Drug: Ribavirin Drug: Pegylated Interferon Alfa 2a
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Telaprevir	Drug	tablet	Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week

Measure	Description	Time Frame
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	24 weeks after the completion of study drug dosing (up to Week 72)

Measure	Description	Time Frame
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	12 weeks after the completion of study drug dosing (up to Week 60)

Eligibility Module

Name	Affiliation	Role
Medical Monitor	Vertex Pharmaceuticals Incorporated	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Call For Information		Phoenix	Arizona		United States
Cedars-Sinai Medical Center

PubMed Identifier	Type	Citation	Retractions
19403902	Derived	McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104.

ID	Title	Description
FG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.

Arm/Group Information

ID	Title	Description
BG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.
BG001	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.
BG002	Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.
BG003	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily 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.
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 Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.

Posted

Number

percentage of participants

24 weeks after the completion of study drug dosing (up to Week 72)

ID	Title	Description
OG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.
OG001	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.
OG002	Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.
OG003	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily 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.

Units	Counts
Participants	OG00075 OG00179 OG00279 OG003

Title

Denominators

Categories

Title	Measurements
	OG00041.3(30 to 53) OG00167.1(56 to 77) OG00260.8(49 to 72) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Logistic	Treatment, weight, race and baseline HCV RNA as factors	0.0014		Odds Ratio (OR)	2.985			2-Sided	95	1.525	5.842				No	Superiority or Other
OG000 OG002		Regression, Logistic

Secondary

Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.

Posted

Number

percentage of participants

12 weeks after the completion of study drug dosing (up to Week 60)

ID	Title	Description
OG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.
OG001	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.

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 (including placebo, if applicable) administered during the course of the study.

The Full Analysis set included all randomized subjects who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to Week 48

ID	Title	Description
OG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.

Secondary

Number of Subjects With Viral Relapse

Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Analysis population included subjects who completed their assigned study drug treatment and had undetectable HCV RNA at the completion of treatment (up to Week 48).

Posted

Number

participants

After last dose of study drug up to antiviral follow-up (up to Week 72)

ID	Title	Description
OG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.
OG001	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.

Secondary

Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.

Pharmacokinetic population included all subjects who provided pharmacokinetic assessments and had evaluable and interpretable data.

Posted

Mean

Standard Deviation

nanogram per milliliter (ng/mL)

Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

ID	Title	Description
OG000	Telaprevir	All Subjects from "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week", "Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week", and "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week" reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week	Placebo (PBO) matched to telaprevir tablet orally thrice 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 48 weeks.	4	75	75	75
EG001	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.	5	79	79	79
EG002	Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice 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.	10	79	79	79
EG003	Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week	Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily 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.	3	17	17	17

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG0030 affected17 at risk
FURUNCLE	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
LOBAR PNEUMONIA	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0021 affected79 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
EXFOLIATIVE RASH	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
SCOTOMA	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
RETINAL EXUDATES	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
RETINAL INFARCTION	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
DEAFNESS NEUROSENSORY	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
ADRENAL DISORDER	Endocrine disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
FATIGUE	General disorders	MedDRA 9.0	Systematic Assessment	EG00057 affected75 at risk EG00158 affected79 at risk EG00255 affected79 at risk EG00314 affected17 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 9.0	Systematic Assessment	EG00032 affected75 at risk EG00130 affected79 at risk EG00239 affected79 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA 9.0	Systematic Assessment	EG00018 affected75 at risk EG00125 affected79 at risk EG00222 affected79 at risk EG003
PYREXIA	General disorders	MedDRA 9.0	Systematic Assessment	EG00022 affected75 at risk EG00115 affected79 at risk EG00216 affected79 at risk EG003
IRRITABILITY	General disorders	MedDRA 9.0	Systematic Assessment	EG00022 affected75 at risk EG0018 affected79 at risk EG00213 affected79 at risk EG003
CHILLS	General disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected75 at risk EG00118 affected79 at risk EG0028 affected79 at risk EG003
PAIN	General disorders	MedDRA 9.0	Systematic Assessment	EG00015 affected75 at risk EG0016 affected79 at risk EG0029 affected79 at risk EG003
PHARMACEUTICAL PRODUCT COMPLAINT	General disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0018 affected79 at risk EG0024 affected79 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0011 affected79 at risk EG0025 affected79 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0013 affected79 at risk EG0024 affected79 at risk EG003
FEELING HOT	General disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0014 affected79 at risk EG0022 affected79 at risk EG003
MALAISE	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0022 affected79 at risk EG003
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00017 affected75 at risk EG00132 affected79 at risk EG00238 affected79 at risk EG003
RASH	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00020 affected75 at risk EG00132 affected79 at risk EG00224 affected79 at risk EG003
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG00019 affected75 at risk EG00113 affected79 at risk EG00214 affected79 at risk EG003
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0019 affected79 at risk EG00218 affected79 at risk EG003
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected75 at risk EG00113 affected79 at risk EG0028 affected79 at risk EG003
PRURITUS GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG00114 affected79 at risk EG0028 affected79 at risk EG003
HYPOTRICHOSIS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0018 affected79 at risk EG0026 affected79 at risk EG003
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0016 affected79 at risk EG0024 affected79 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected75 at risk EG0014 affected79 at risk EG0021 affected79 at risk EG003
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0012 affected79 at risk EG0026 affected79 at risk EG003
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0012 affected79 at risk EG0023 affected79 at risk EG003
RASH PAPULAR	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0014 affected79 at risk EG0022 affected79 at risk EG003
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0013 affected79 at risk EG0025 affected79 at risk EG003
INCREASED TENDENCY TO BRUISE	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0013 affected79 at risk EG0023 affected79 at risk EG003
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0014 affected79 at risk EG0022 affected79 at risk EG003
RASH MACULAR	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0012 affected79 at risk EG0024 affected79 at risk EG003
ECZEMA ASTEATOTIC	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
STASIS DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00022 affected75 at risk EG00138 affected79 at risk EG00244 affected79 at risk EG003
DIARRHOEA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG00021 affected75 at risk EG00127 affected79 at risk EG00233 affected79 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected75 at risk EG00116 affected79 at risk EG00219 affected79 at risk EG003
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG00113 affected79 at risk EG00210 affected79 at risk EG003
DYSPEPSIA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0018 affected79 at risk EG0027 affected79 at risk EG003
DRY MOUTH	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected75 at risk EG0018 affected79 at risk EG0028 affected79 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0018 affected79 at risk EG0026 affected79 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected75 at risk EG0014 affected79 at risk EG0026 affected79 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected75 at risk EG0013 affected79 at risk EG0026 affected79 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected75 at risk EG0011 affected79 at risk EG0025 affected79 at risk EG003
FLATULENCE	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0016 affected79 at risk EG0023 affected79 at risk EG003
ANAL DISCOMFORT	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0013 affected79 at risk EG0026 affected79 at risk EG003
STOMACH DISCOMFORT	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected75 at risk EG0011 affected79 at risk EG0024 affected79 at risk EG003
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0012 affected79 at risk EG0024 affected79 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0015 affected79 at risk EG0024 affected79 at risk EG003
APHTHOUS STOMATITIS	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0012 affected79 at risk EG0022 affected79 at risk EG003
FREQUENT BOWEL MOVEMENTS	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0012 affected79 at risk EG0024 affected79 at risk EG003
PAINFUL DEFAECATION	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0024 affected79 at risk EG003
PRURITUS ANI	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0024 affected79 at risk EG003
CHAPPED LIPS	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0011 affected79 at risk EG0021 affected79 at risk EG003
GINGIVAL PAIN	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
LOOSE TOOTH	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00045 affected75 at risk EG00134 affected79 at risk EG00237 affected79 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected75 at risk EG00115 affected79 at risk EG00222 affected79 at risk EG003
DYSGEUSIA	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected75 at risk EG0018 affected79 at risk EG0028 affected79 at risk EG003
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0016 affected79 at risk EG0024 affected79 at risk EG003
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0012 affected79 at risk EG0027 affected79 at risk EG003
TREMOR	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0013 affected79 at risk EG0023 affected79 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0011 affected79 at risk EG0024 affected79 at risk EG003
HYPERAESTHESIA	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0014 affected79 at risk EG0022 affected79 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0011 affected79 at risk EG0022 affected79 at risk EG003
SOMNOLENCE	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
PAROSMIA	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
POOR QUALITY SLEEP	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
COGNITIVE DISORDER	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
MENTAL IMPAIRMENT	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
TENSION HEADACHE	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
INSOMNIA	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00029 affected75 at risk EG00127 affected79 at risk EG00235 affected79 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected75 at risk EG00115 affected79 at risk EG00217 affected79 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG00013 affected75 at risk EG00111 affected79 at risk EG0026 affected79 at risk EG003
MOOD SWINGS	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0015 affected79 at risk EG0022 affected79 at risk EG003
LIBIDO DECREASED	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0014 affected79 at risk EG0021 affected79 at risk EG003
TEARFULNESS	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0012 affected79 at risk EG0021 affected79 at risk EG003
AGITATION	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00016 affected75 at risk EG00117 affected79 at risk EG00213 affected79 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00018 affected75 at risk EG00115 affected79 at risk EG0029 affected79 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG00012 affected75 at risk EG0018 affected79 at risk EG0026 affected79 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected75 at risk EG0017 affected79 at risk EG0028 affected79 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0014 affected79 at risk EG0024 affected79 at risk EG003
BUTTOCK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
MUSCULOSKELETAL DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00014 affected75 at risk EG00116 affected79 at risk EG00217 affected79 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG00011 affected75 at risk EG00110 affected79 at risk EG00212 affected79 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected75 at risk EG0015 affected79 at risk EG0024 affected79 at risk EG003
PHARYNGOLARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0008 affected75 at risk EG0013 affected79 at risk EG0025 affected79 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected75 at risk EG0016 affected79 at risk EG0025 affected79 at risk EG003
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0005 affected75 at risk EG0016 affected79 at risk EG0022 affected79 at risk EG003
ANAEMIA	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG00020 affected75 at risk EG00123 affected79 at risk EG00229 affected79 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG00018 affected75 at risk EG00119 affected79 at risk EG00211 affected79 at risk EG003
SINUSITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0007 affected75 at risk EG0014 affected79 at risk EG0024 affected79 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0016 affected79 at risk EG0025 affected79 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0012 affected79 at risk EG0022 affected79 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0012 affected79 at risk EG0022 affected79 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
LOCALISED INFECTION	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
VISION BLURRED	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0006 affected75 at risk EG00114 affected79 at risk EG00210 affected79 at risk EG003
DRY EYE	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0013 affected79 at risk EG0024 affected79 at risk EG003
PHOTOPHOBIA	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0014 affected79 at risk EG0021 affected79 at risk EG003
CONJUNCTIVITIS	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
EYE PRURITUS	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
VITREOUS FLOATERS	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0012 affected79 at risk EG0020 affected79 at risk EG003
LACRIMATION INCREASED	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
OCULAR ICTERUS	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
SCOTOMA	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
CATARACT	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
RETINAL EXUDATES	Eye disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0009 affected75 at risk EG00111 affected79 at risk EG00210 affected79 at risk EG003
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0013 affected79 at risk EG0024 affected79 at risk EG003
ANOREXIA	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0010 affected79 at risk EG0022 affected79 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0025 affected79 at risk EG003
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0024 affected79 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0014 affected79 at risk EG0024 affected79 at risk EG003
BLOOD PRESSURE INCREASED	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0022 affected79 at risk EG003
WEIGHT DECREASED	Investigations	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0011 affected79 at risk EG0020 affected79 at risk EG003
TINNITUS	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0004 affected75 at risk EG0010 affected79 at risk EG0026 affected79 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0012 affected79 at risk EG0022 affected79 at risk EG003
POLLAKIURIA	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0002 affected75 at risk EG0013 affected79 at risk EG0025 affected79 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0011 affected79 at risk EG0021 affected79 at risk EG003
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
CONTACT LENS COMPLICATION	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003
FLUSHING	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 affected75 at risk EG0010 affected79 at risk EG0021 affected79 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0003 affected75 at risk EG0012 affected79 at risk EG0020 affected79 at risk EG003
JAUNDICE	Hepatobiliary disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected75 at risk EG0010 affected79 at risk EG0020 affected79 at risk EG003

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
D012254	Ribavirin
C100416	peginterferon alfa-2a