VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus... | NCT01241760

NCT01241760

ID	Type	Description
OPTIMIZE-HCV	Other Identifier	Janssen Infectious Diseases BVBA
VX-950-C211	Other Identifier	Janssen Infectious Diseases BVBA
2010-021628-84	EudraCT Number

Status Module

Name	Class
Vertex Pharmaceuticals Incorporated	INDUSTRY

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
001 T(q8h) / PR	Experimental	Telaprevir (T) 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)	Drug: Ribavirin Drug: Pegylated interferon alfa-2a Drug: Telaprevir
002 T(b.i.d.) / PR	Experimental	Telaprevir (T) 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (P) and ribavirin (R)	Drug: Ribavirin Drug: Telaprevir Drug: Pegylated interferon alfa-2a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug	Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)	The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).	End of trial, 12 weeks after last planned dose

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)	The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.

Eligibility Module

Name	Affiliation	Role
Janssen Infectious Diseases BVBA Clinical Trial	Janssen Infectious Diseases BVBA	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25653396	Derived	Sarrazin C, Dierynck I, Cloherty G, Ghys A, Janssen K, Luo D, Witek J, Buti M, Picchio G, De Meyer S. An OPTIMIZE study retrospective analysis for management of telaprevir-treated hepatitis C virus (HCV)-infected patients by use of the Abbott RealTime HCV RNA assay. J Clin Microbiol. 2015 Apr;53(4):1264-9. doi: 10.1128/JCM.03030-14. Epub 2015 Feb 4.
24316262

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
BG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0003 BG0010 BG0023
Between 18 and 65 years

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00048(18 to 70) BG00147.5(19 to 70) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000136 BG001160 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Europe

Title	Measurements
	BG000192 BG001179 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Drugs (SVR12 Planned)

The table below shows the percentage of participants achieving Sustained Virologic Response 12 weeks after last planned dose of study medication (SVR12 planned). SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL).

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants with response

End of trial, 12 weeks after last planned dose

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Units	Counts
Participants	OG000371 OG001369

Title

Denominators

Categories

Title	Measurements
	OG00072.8 OG00174.3

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	The 95% confidence interval of the difference in proportions was estimated using a logistic regression model.			Difference in proportion of response, %	1.5				95	-4.9	12			Observed data	Yes	Non-Inferiority or Equivalence	If the lower limit of the 95% confidence interval of the difference in proportions was above the pre-determined non-inferiority margin of -11%, non-inferiority was established.

Secondary

Percentage of Participants With Sustained Virologic Response 24 Weeks After the Last Planned Dose of Study Drugs (SVR24 Planned)

The table below shows the percentage of participants achieving SVR 24 weeks after the last planned dose of study medication. SVR was defined as having Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 international units/milliliter (IU/mL). The response for T12(b.i.d)/PR group is higher than that after 12 weeks because HCV RNA data for two participants were missing for SVR assessment at that time. Consequently, by definition of SVR12, they were counted as not having achieved SVR12.

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants with response

End of trial, 24 weeks after last planned dose

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Secondary

Percentage of Participants With Sustained Virologic Response 72 Weeks After the Start of Study Medication (SVR72 Planned)

The table below shows the percentage of participants achieving SVR 72 weeks after the start of study medication (SVR72 planned). SVR was defined as having plasma Hepatitis C Virus (HCV) ribonucleic acid (RNA) levels less than 25 IU/mL, target not detected, at end of treatment and up to 72 weeks after start of study medication (i.e., no confirmed detectable HCV RNA in between).

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants with response

End of trial, 72 weeks after the start of study medication

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Secondary

Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected, at Different Time Points.

The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels, which means less than 25 IU/ml, target not detected, at different time points during the study.

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants with response

Baseline, Week 4 and Week 4+12.

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Secondary

Percentage of Participants With On-treatment Virologic Failure Which Required Them to Permanently Discontinue All Study Drugs

The table below shows the percentage of participants who met a stopping rule, defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value at Week 4 >1000 IU/mL and at Weeks 12, 24, 32 and 40 ≥25 IU/mL.

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants

Week 4, 12, 24, 32, 40

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Secondary

Percentage of Participants Who Relapsed During Follow-up Period

The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 12-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).

The analysis was performed on subjects with HCV RNA <25 IU/mL at the planned end of treatment, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.

Posted

Number

percentage of participants

During Follow-Up (24 weeks after the last dose of study drug)

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Secondary

Percentage of Participants of Each IL28B Genotype Achieving Sustained Virologic Response 12 Weeks After the Last Planned Dose of Study Medication (SVR12 Planned)

The table below shows the effect of interleukin 28B (IL28B) gene's subtype (CC, CT or TT genotype) on the primary outcome measure: SVR12 planned.

All analyses were performed on the full analysis (FA) set, which was defined as all randomized subjects who received at least one dose of study drug.

Posted

Number

percentage of participants with response

End of trial, 12 weeks after the last planned dose

ID	Title	Description
OG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
OG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	T12(q8h)/PR	Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.	35	371	359	371
EG001	T12(b.i.d.)/PR	Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.	28	369	358	369
EG002	Total	All	63	740	717	740

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG00014 affected371 at risk EG00113 affected369 at risk EG00227 affected740 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected371 at risk EG0010 affected369 at risk EG0022 affected740 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Abscess	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Cellulitis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Escherichia sepsis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Sinusitis	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Asthenia	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Chest discomfort	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Chest pain	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Fatigue	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Pyrexia	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Non-cardiac chest pain	General disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0012 affected369 at risk EG0023 affected740 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Drug rash with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Syncope	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0003 affected371 at risk EG0012 affected369 at risk EG0025 affected740 at risk
Facial palsy	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Hemiparesis	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Myoclonus	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Paraesthesia	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.0	Non-systematic Assessment	EG0002 affected371 at risk EG0010 affected369 at risk EG0022 affected740 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Electrocardiogram t wave inversion	Investigations	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Suicide attempt	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0011 affected369 at risk EG0022 affected740 at risk
Disorientation	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Mental status changes	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0001 affected371 at risk EG0010 affected369 at risk EG0021 affected740 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0012 affected369 at risk EG0022 affected740 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 11.0	Non-systematic Assessment	EG0000 affected371 at risk EG0011 affected369 at risk EG0021 affected740 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 11.0	Non-systematic Assessment	EG000178 affected371 at risk EG001173 affected369 at risk EG002351 affected740 at risk
Pyrexia	General disorders	MedDRA 11.0	Non-systematic Assessment	EG00078 affected371 at risk EG00162 affected369 at risk EG002140 affected740 at risk
Asthenia	General disorders	MedDRA 11.0	Non-systematic Assessment	EG00072 affected371 at risk EG00165 affected369 at risk EG002137 affected740 at risk
Influenza like illness	General disorders	MedDRA 11.0	Non-systematic Assessment	EG00060 affected371 at risk EG00175 affected369 at risk EG002135 affected740 at risk
Chills	General disorders	MedDRA 11.0	Non-systematic Assessment	EG00043 affected371 at risk EG00122 affected369 at risk EG00265 affected740 at risk
Injection site reaction	General disorders	MedDRA 11.0	Non-systematic Assessment	EG00025 affected371 at risk EG00123 affected369 at risk EG00248 affected740 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG000158 affected371 at risk EG001158 affected369 at risk EG002316 affected740 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG000133 affected371 at risk EG001129 affected369 at risk EG002262 affected740 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG00035 affected371 at risk EG00143 affected369 at risk EG00278 affected740 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG00022 affected371 at risk EG00120 affected369 at risk EG00242 affected740 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG000143 affected371 at risk EG001129 affected369 at risk EG002272 affected740 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00071 affected371 at risk EG00149 affected369 at risk EG002120 affected740 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00043 affected371 at risk EG00130 affected369 at risk EG00273 affected740 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00041 affected371 at risk EG00138 affected369 at risk EG00279 affected740 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00036 affected371 at risk EG00139 affected369 at risk EG00275 affected740 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00033 affected371 at risk EG00126 affected369 at risk EG00259 affected740 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00023 affected371 at risk EG00124 affected369 at risk EG00247 affected740 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00022 affected371 at risk EG00115 affected369 at risk EG00237 affected740 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00021 affected371 at risk EG00118 affected369 at risk EG00239 affected740 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00019 affected371 at risk EG00110 affected369 at risk EG00229 affected740 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG000148 affected371 at risk EG001155 affected369 at risk EG002303 affected740 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG00030 affected371 at risk EG00136 affected369 at risk EG00266 affected740 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 11.0	Non-systematic Assessment	EG00030 affected371 at risk EG00129 affected369 at risk EG00259 affected740 at risk
Headache	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG000108 affected371 at risk EG00187 affected369 at risk EG002195 affected740 at risk
Dysgeusia	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG00046 affected371 at risk EG00136 affected369 at risk EG00282 affected740 at risk
Dizziness	Nervous system disorders	MedDRA 11.0	Non-systematic Assessment	EG00030 affected371 at risk EG00141 affected369 at risk EG00271 affected740 at risk
Insomnia	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG00068 affected371 at risk EG00169 affected369 at risk EG002137 affected740 at risk
Mood altered	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG00047 affected371 at risk EG00137 affected369 at risk EG00284 affected740 at risk
Depression	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG00036 affected371 at risk EG00127 affected369 at risk EG00263 affected740 at risk
Anxiety	Psychiatric disorders	MedDRA 11.0	Non-systematic Assessment	EG00020 affected371 at risk EG00126 affected369 at risk EG00246 affected740 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00044 affected371 at risk EG00139 affected369 at risk EG00283 affected740 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00035 affected371 at risk EG00136 affected369 at risk EG00271 affected740 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Non-systematic Assessment	EG00019 affected371 at risk EG00117 affected369 at risk EG00236 affected740 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG00041 affected371 at risk EG00133 affected369 at risk EG00274 affected740 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Non-systematic Assessment	EG00024 affected371 at risk EG00125 affected369 at risk EG00249 affected740 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA 11.0	Non-systematic Assessment	EG00036 affected371 at risk EG00130 affected369 at risk EG00266 affected740 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 11.0	Non-systematic Assessment	EG00019 affected371 at risk EG00122 affected369 at risk EG00241 affected740 at risk
Vision blurred	Eye disorders	MedDRA 11.0	Non-systematic Assessment	EG00017 affected371 at risk EG00120 affected369 at risk EG00237 affected740 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		La Jolla	California		United States

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

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

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