An Observational Study to Assess the Effect of Cumulative... | NCT02557646

Status 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
Pegasys + Copegus		Treatment naive participants with confirmed chronic hepatitis C who are started on combined Pegasys-Copegus treatment in accordance with current guidelines and SPCs, and whose treatment has been approved by the Interferon Committee.	Biological: Peginterferon alfa-2a Drug: Ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon alfa-2a	Biological	Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P	Pegasys + Copegus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin	Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.	24 weeks after EOT (maximum up to 96 Weeks)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Virologic Response	Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.	Week 4, 12, 24 and at EOT (maximum up to 72 weeks)

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Out of total 693 participants in ITT population, data for only 692 participants was available for this baseline measure.

Mean

Standard Deviation

years

Title

Denominators

Categories

Cumulative dose of ribavirin <60% (n=35)

Title	Measurements
	OG00054.29

Cumulative dose of ribavirin = 60-69% (n=23)

Title	Measurements
	OG00060.87

Cumulative dose of ribavirin = 70-79% (n=32)

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	Cumulative dose of ribavirin >90%: the relationship between cumulative dose and SVR response in participants in whom the cumulative dose of ribavirin exceeded 90% was analyzed using Chi-square test.	Chi-squared		0.0437						2-Sided							No	Superiority or Other

Secondary

Percentage of Participants With Virologic Response

ITT Population.

Posted

Number

percentage of participants

Week 4, 12, 24 and at EOT (maximum up to 72 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.

Posted

Number

percentage of participants

Up to EOT (maximum up to 72 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With SVR According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.

Posted

Number

percentage of participants

24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.

Posted

Number

percentage of participants

Up to EOT (maximum up to 72 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.

Posted

Number

percentage of participants

24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts

Secondary

Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

ITT Population.

Posted

Number

percentage of participants

Up to EOT (maximum up to 72 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With SVR According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

Posted

Number

percentage of participants

24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units

Secondary

Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.

Posted

Number

percentage of participants

Up to EOT (maximum up to 72 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With SVR According to IL-28B Polymorphism

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.

Posted

Number

percentage of participants

24 weeks after EOT (maximum up to 96 Weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With Viral Relapse or Breakthrough

ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Up to 24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Units	Counts
Participants

Secondary

Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.

ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Up to 24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Secondary

Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.

ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Secondary

Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.

ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Up to 24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Secondary

Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin

Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

ITT Population showing virological response. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure.

Posted

Number

percentage of participants

Up to 24 weeks after EOT (maximum up to 96 weeks)

ID	Title	Description
OG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Peginterferon Alfa-2a + Ribavirin	Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant's individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.			52	697	353	697

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00014 affected697 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected697 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0004 affected697 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected697 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Tachycardia	Cardiac disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Oesophageal polyp	Gastrointestinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Unevaluable event	General disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Jaundice	Hepatobiliary disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Sarcoidosis	Immune system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Laryngitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Peritonitis	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0002 affected697 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Viral infection	Infections and infestations	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Syncope	Nervous system disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected697 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0002 affected697 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Cutaneous sarcoidosis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Toxic epidermal necrolysis	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.1	Non-systematic Assessment	EG0001 affected697 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG000103 affected697 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00039 affected697 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00037 affected697 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.1	Non-systematic Assessment	EG00040 affected697 at risk
Asthenia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00051 affected697 at risk
Fatigue	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00091 affected697 at risk
Influenza like illness	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00065 affected697 at risk
Pyrexia	General disorders	MedDRA 18.1	Non-systematic Assessment	EG00049 affected697 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.1	Non-systematic Assessment	EG00035 affected697 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Non-systematic Assessment	EG00049 affected697 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG00049 affected697 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.1	Non-systematic Assessment	EG00035 affected697 at risk

Ancestor Terms

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

Facility	Status	City	State	ZIP	Country	Contacts
		Ajka		H-8400	Hungary

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