A Retrospective Study to Assess the Impact of the Use of... | NCT01280656

Status Module

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Conventional Interferon Plus Ribavirin	Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Conventional Interferon Drug: Ribavirin
Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Peginterferon Alfa-2a Drug: Ribavirin
Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).	Drug: Peginterferon Alfa-2b Drug: Ribavirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conventional Interferon	Drug	Conventional interferon according to the standard of care and aligned with the local prescription instructions	Conventional Interferon Plus Ribavirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response at 12 Weeks After End of Treatment	Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.	At Week 60

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment	SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
BG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
BG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
BG003	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 Participants With Sustained Virologic Response at 12 Weeks After End of Treatment

Sustained virological response (SVR) was defined as virological response at 12 weeks after end of treatment (EOT). Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 international units/milliliter (IU/mL) HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). EOT= Week 48. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.

The intent-to-treat (ITT) population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).

Posted

Number

percentage of participants

At Week 60

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Units	Counts
Participants	OG00016 OG001126 OG002101

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0017.1 OG00220.8

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
OG001 OG002		Chi-squared		0.003						2-Sided							No	Superiority or Other

Secondary

Percentage of Participants With Sustained Virologic Response at 24 Weeks After End of Treatment

SVR was defined as virological response at 24 weeks after EOT, EOT= Week 48. Virologic response was either defined as having undetectable (that is, no hepatitis C virus Ribonucleic acid [HCV RNA] was detected in the participants' plasma samples) or less than 50 IU/mL HCV RNA (that is, the participants' plasma samples contained traces of HCV RNA at a concentration below the limit of quantification of the viral load assay or no HCV RNA was detected in the samples). Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in participants with virologic response at EOT in each group (16, 126, and 101 respectively).

Posted

Number

percentage of participants

At Week 72

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Number of Participants With Interferon Dose Reduction Rates in Function of the Interferon Type Being Used

The number of participants with Interferon dose reduction rates in function of the interferon type being used are reported

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis was performed in the participants who were available for interferon dose reduction rates in each group (56, 302, and 280 respectively).

Posted

Number

participants

At Week 24

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants With Early Virologic Response at Week 12

An early virologic response (EVR) was defined as a HCV-RNA decrease of at least two logarithmic scales (2 Log) or 100 times the pretreatment value or non-detection at Week 12 of treatment period.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

percentage of participants

At Week 12

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants With Sustained Virologic Response Treated at Interferon Application Centers and Treated at Home

The percentage of participants with SVR-12 and SVR-24 treated at interferon application centers (IAC) and treated at home are presented.

Posted

Number

percentage of participants

At Week 60 (SVR 12) and Week 72 (SVR 24)

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin

Secondary

Percentage of Participants Who Were Treated at Interferon Application Centers and at Home and Discontinued Treatment

The percentage of participants who were treated at interferon application centers and at home and who discontinued treatment is presented. Participants who did not have viral load assessment at Week 12 were considered treatment failures, except in the specific case where the lack of assessment was not due to treatment shortening in function of response guided therapy.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. The analysis excluded participants treated at an unknown location (7/62, 10/312, and 23/286 respectively)

Posted

Number

percentage of participants

Up to Week 48

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Mean Percentage Reduction of Hemoglobin in Treatment Responders and Treatment Non-Responders

The average percentage reduction of hemoglobin (Hb) in treatment responders and treatment non-responders between the conventional group, peginterferon alfa-2a plus and peginterferon alfa-2b is presented. Participants with undetectable HCV RNA at specified time points (Weeks 4/12/18/24/48) were considered as treatment responders. Participants with positive viral load (detectable HCV RNA) at end of treatment regardless of the treatment duration were considered as treatment non-responders.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria. Treatment responders and non-responders for whom data was available were considered for this outcome measure.

Posted

Mean

Standard Deviation

mean percentage reduction of hemoglobin

Up to Week 72

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants With Rapid Virologic Response at Week 4

Rapid virologic response was defined as qualitative or quantitative HCV-RNA (viral load) undetectable (below the lower limit of detection) at Week 4 of treatment period.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

percentage of participants

At Week 4

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants With Virologic Response at End of Treatment

Virologic response at EOT was defined as undetectable HCV-RNA at EOT (regardless in which week treatment was concluded). EOT = Week 48.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

percentage of participants

At Week 48

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants With Virologic Relapse up to Week 72

Virologic relapse was defined as undetectable HCV-RNA at end of treatment and detectable HCV-RNA at the last follow-up assessment available. If the participant was a responder at end of treatment and was not submitted to any viral load assessment during the follow-up period, he was considered a relapser.

Posted

Number

percentage of participants

Up to Week 72

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin

Secondary

Percentage of Participants With Null Response or No Responder at End of Treatment

Null response or no responders were defined as those participants presenting positive viral load at EOT (regardless of the treatment duration). EOT= Week 48.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

percentage of participants

At Week 48

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Percentage of Participants Who Discontinued Treatment Due to Adverse Events

The percentage of participants with treatment discontinuation rates due to adverse events (AE) between conventional group, peginterferon alfa-2a and peginterferon alfa-2b is presented.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

percentage of participants

Up to Week 48

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Secondary

Number of Participants With Any Adverse Events and Any Serious Adverse Events

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes.

The ITT population consisted of participants who fulfilled all inclusion/ exclusion criteria.

Posted

Number

participants

Up to Week 72

ID	Title	Description
OG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
OG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Conventional Interferon Plus Ribavirin	Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.	2	62	55	62
EG001	Peginterferon Alfa-2a Plus Ribavirin	Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy	15	312	275	312
EG002	Peginterferon Alfa-2b Plus Ribavirin	Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.	9	286	262	286

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gallstones	Hepatobiliary disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Thoracic pain	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0023 affected286 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Neutropaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Febrile neutropaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Thrombocytopaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Cryoglobulinaemia	Immune system disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Breast mass	Reproductive system and breast disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Appendicitis	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG0010 affected312 at risk EG0020 affected286 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0010 affected312 at risk EG0021 affected286 at risk
Urinary tract infection	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0021 affected286 at risk
Cell tissue inflammation	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Osteomyelitis	Infections and infestations	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Vocal cord neoplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Breast tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk
Depression	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG0010 affected312 at risk EG0020 affected286 at risk
Thrombophlebitis	Vascular disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG0011 affected312 at risk EG0020 affected286 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0008 affected62 at risk EG00128 affected312 at risk EG00226 affected286 at risk
Itch	Skin and subcutaneous tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0009 affected62 at risk EG00150 affected312 at risk EG00244 affected286 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0006 affected62 at risk EG00116 affected312 at risk EG00216 affected286 at risk
Pain in extremities	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG00115 affected312 at risk EG00216 affected286 at risk
Dorsalgia	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG0019 affected312 at risk EG00219 affected286 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (17.0)	Systematic Assessment	EG0008 affected62 at risk EG00151 affected312 at risk EG00233 affected286 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG00012 affected62 at risk EG00175 affected312 at risk EG00252 affected286 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected62 at risk EG0019 affected312 at risk EG00217 affected286 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG00011 affected62 at risk EG001109 affected312 at risk EG002111 affected286 at risk
Leucopaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG00114 affected312 at risk EG00220 affected286 at risk
Neutropaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected62 at risk EG00160 affected312 at risk EG00245 affected286 at risk
Thrombocytopaenia	Blood and lymphatic system disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected62 at risk EG00127 affected312 at risk EG00221 affected286 at risk
Headache	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG00019 affected62 at risk EG00167 affected312 at risk EG00267 affected286 at risk
Insomnia	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0006 affected62 at risk EG00143 affected312 at risk EG00230 affected286 at risk
Dizziness	Nervous system disorders	MedDRA (17.0)	Systematic Assessment	EG0005 affected62 at risk EG00128 affected312 at risk EG00225 affected286 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected62 at risk EG00121 affected312 at risk EG00227 affected286 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0001 affected62 at risk EG00110 affected312 at risk EG00216 affected286 at risk
High abdominal pain	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected62 at risk EG00125 affected312 at risk EG00223 affected286 at risk
Nausea	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG00010 affected62 at risk EG00157 affected312 at risk EG00245 affected286 at risk
Vomiting	Gastrointestinal disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected62 at risk EG00121 affected312 at risk EG00220 affected286 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (17.0)	Systematic Assessment	EG0000 affected62 at risk EG00123 affected312 at risk EG00211 affected286 at risk
Anxiety	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected62 at risk EG00112 affected312 at risk EG00219 affected286 at risk
Depression	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0002 affected62 at risk EG00136 affected312 at risk EG00235 affected286 at risk
Irritability	Psychiatric disorders	MedDRA (17.0)	Systematic Assessment	EG0004 affected62 at risk EG00141 affected312 at risk EG00231 affected286 at risk
Asthenia	General disorders	MedDRA (17.0)	Systematic Assessment	EG00023 affected62 at risk EG001114 affected312 at risk EG002107 affected286 at risk
Pain	General disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected62 at risk EG00119 affected312 at risk EG00230 affected286 at risk
Flu condition	General disorders	MedDRA (17.0)	Systematic Assessment	EG0003 affected62 at risk EG00125 affected312 at risk EG00250 affected286 at risk
Fatigue	General disorders	MedDRA (17.0)	Systematic Assessment	EG0009 affected62 at risk EG00136 affected312 at risk EG00235 affected286 at risk
Malaise	General disorders	MedDRA (17.0)	Systematic Assessment	EG0007 affected62 at risk EG00119 affected312 at risk EG00221 affected286 at risk
Pyrexia	General disorders	MedDRA (17.0)	Systematic Assessment	EG00016 affected62 at risk EG00165 affected312 at risk EG00266 affected286 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Rio Branco	Acre	69908-210	Brazil

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
C100416	peginterferon alfa-2a
C417083	peginterferon alfa-2b
D012254	Ribavirin