REPEAT Study - A Study of PEGASYS (Peginterferon Alfa-2a... | NCT00087646

NCT00087646

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	Intervention Names
1	Experimental	Drug: Ribavirin Drug: peginterferon alfa-2a [Pegasys]
2	Experimental	Drug: Ribavirin Drug: peginterferon alfa-2a [Pegasys]
3	Experimental	Drug: Ribavirin Drug: peginterferon alfa-2a [Pegasys]
4	Active Comparator	Drug: Ribavirin Drug: peginterferon alfa-2a [Pegasys]

Name	Type	Description	Arm Group Labels	Other Names
Ribavirin	Drug	1000/1200mg po daily for 72 weeks	1 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Sustained Virological Response Rate	Sustained Virological Response (SVR) was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.	Up to 72 weeks (Group A) and 48 weeks (Group D)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)	SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23442834	Derived	Marcellin P, Craxi A, Brandao-Mello CE, Di Bisceglie AM, Andreone P, Freilich B, Rajender Reddy K, Olveira Martin A, Teuber G, Messinger D, Hooper G, Wat C, Tatsch F, Jensen DM. Predicting early and sustained virological responses in prior nonresponders to pegylated interferon alpha-2b plus ribavirin retreated with peginterferon alpha-2a plus ribavirin and the benefit-risk ratio of retreatment. J Clin Gastroenterol. 2013 Oct;47(9):786-93. doi: 10.1097/MCG.0b013e31827b9b45.

Label	URL
This is a full publication titled Re-treatment of Patients With Chronic Hepatitis C Who Do Not Respond to Peginterferon- alfa2b, A Randomized Trial	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
FG001	Group B

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
BG001	Group B	Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
BG002	Group C	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
BG003	Group D	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
BG004	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, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00052 OG00127

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	Group A Vs Group D	Cochran-Mantel-Haenszel		0.0060		Odds Ratio (OR)	2.00			2-Sided	95	1.21	3.31				No	Superiority or Other

Secondary

Number of Participants With Sustained Virological Response (Groups A + B vs Groups C + D)

SVR was defined as the percentage of participants with a undetectable hepatitis C virus- ribonucleic acid (HCV RNA) 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 International Units Per Millilitre (IU/mL) measured >= 20 weeks after treatment end, ie, >=140 days after treatment end.

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

participants

At Week 48 and Week 72

ID	Title	Description
OG000	Group A + Group B	Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks. Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
OG001	Group C + Group D	Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks. Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.

Secondary

Number of Participants With Sustained Virological Response (Groups A + C vs Groups B + D)

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

participants

At Week 48 and Week 72

ID	Title	Description
OG000	Group A + Group C	Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks. Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
OG001	Group B + Group D	Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks. Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.

Secondary

Percentage of Participants With Undetectable HCV-RNA

The percentage of participants with a undetectable HCV RNA 24 weeks after the end of the treatment period (defined as a single last HCV RNA < 50 IU/mL measured >= 20 weeks after treatment end, ie, >=140 days after treatment end) are reported.

End-of-treatment (EOT) virological response is defined as last HCV RNA measurement that is not detectable (<50 IU/mL) at study day of last dose of study medication (+/- 28 days).

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

At Week 12, 24, 48 and EOT

ID	Title	Description
OG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
OG001	Group D	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.

Units	Counts
Participants

Secondary

Percentage of Participants With >=2log Drop in HCV-RNA

Reduction in HCV-RNA titers of at least 2 log10 after 12/24 weeks of study treatment (i.e. 99% reduction of viral load) was analyzed. Percentage of participants with at least a 2 log10 drop of HCV-RNA at study week 12 and 24 (lower limit of quantitation 600 IU/mL) as compared to baseline or non-detectable HCV-RNA (lower limit of detection 50 IU/mL) were reported.

ITT population included all the participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

At Week 12 and 24

ID	Title	Description
OG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
OG001	Group D	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Reduction of HCV Viremia (Groups A + B vs Groups C + D)

The mean change from baseline in HCV RNA level (reduction in viral load) at Week 12 and 24 were determined. HCV RNA result were not detectable (<50 IU/ML) and not quantifiable (<600 IU/ML). Baseline value were assessed on Day 1 before the administration of the first dose of study drug.

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Mean

95% Confidence Interval

IU/ML

At Week 12 and 24

ID	Title	Description
OG000	Group A + Group B	Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks. Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
OG001	Group C + Group D	Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks. Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.

Secondary

Percentage of Participants With Maintenance of Actual End-of-Treatment Virological Response

Maintenance of end-of-treatment virological response was assessed based on all participants treated and according to the actual treatment period (backward imputation method). The percentage of participants who maintained their end-of-treatment virological response was determined. Maintenance of actual end-of-treatment virological response was calculated by dividing the number of participants with a virological response both at the end of the actual untreated follow-up period and at the end of the actual treatment period by the number of participants with a virological response at the actual end of treatment.

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

Week 96 (Group A and C) and Week 72 (Group B and D)

ID	Title	Description
OG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
OG001	Group B	Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.

Secondary

Percentage of Participants With Relapse After End of Treatment

The percentage of participants who relapsed (loss of response) after having achieved a virological response at the end of treatment was determined.

ITT population included all participants randomized who received at least one dose of study medication.

Posted

Number

percentage of participants

Week 96 (Group A and C) and Week 72 (Group B and D)

ID	Title	Description
OG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
OG001	Group B	Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
OG002	Group C	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
OG003

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A	Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.	33	317	306	317
EG001	Group B	Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.	14	156	151	156
EG002	Group C	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.	28	156	150	156
EG003	Group D	Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.	33	313	298	313

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0004 affected317 at risk EG0011 affected156 at risk EG0022 affected156 at risk EG0031 affected313 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Appendicitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Ear infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Enterococcal sepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Infected insect bite	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Infective spondylitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Influenza	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Osteomyelitis chronic	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Otitis media	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Urosepsis	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Viral infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0002 affected317 at risk EG0010 affected156 at risk EG0022 affected156 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0003 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Agranulocytosis	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Oesophageal varices Haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Mallory-weiss syndrome	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0022 affected156 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Lymphatic system neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Renal cell carcinoma stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Unspecified Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0002 affected317 at risk EG0012 affected156 at risk EG0020 affected156 at risk EG003
Aggression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Depression suicidal	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Vision blurred	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Retinal artery embolism	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Retinal detachment	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Retinal exudates	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Ulcerative keratitis	Eye disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Hepatitis acute	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Insulin-dependent Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment		EG0002 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Influenza like illness	General disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	General disorders and Administration site conditions	EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Facial palsy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Grand mal convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Varicocele	Reproductive system and breast disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Deafness unilateral	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Calculus ureteric	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Dermatitis exfoliative	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment		EG0001 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Raynaud's phenomenon	Vascular disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0021 affected156 at risk EG003
Spondylolisthesis	Congenital, familial and genetic disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003
Sarcoidosis	Immune system disorders	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0011 affected156 at risk EG0020 affected156 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (10.0)	Systematic Assessment		EG0000 affected317 at risk EG0010 affected156 at risk EG0020 affected156 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG000134 affected317 at risk EG00162 affected156 at risk EG00257 affected156 at risk EG003137 affected313 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00088 affected317 at risk EG00143 affected156 at risk EG00249 affected156 at risk EG003
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00081 affected317 at risk EG00144 affected156 at risk EG00233 affected156 at risk EG003
Influenza like illness	General disorders	MedDRA (10.0)	Systematic Assessment	EG00087 affected317 at risk EG00139 affected156 at risk EG00237 affected156 at risk EG003
Irritability	General disorders	MedDRA (10.0)	Systematic Assessment	EG00054 affected317 at risk EG00132 affected156 at risk EG00227 affected156 at risk EG003
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG00047 affected317 at risk EG00129 affected156 at risk EG00219 affected156 at risk EG003
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected317 at risk EG00110 affected156 at risk EG00212 affected156 at risk EG003
Injection site erythema	General disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected317 at risk EG00110 affected156 at risk EG0028 affected156 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00091 affected317 at risk EG00150 affected156 at risk EG00241 affected156 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00066 affected317 at risk EG00131 affected156 at risk EG00227 affected156 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00034 affected317 at risk EG00114 affected156 at risk EG00213 affected156 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00030 affected317 at risk EG00111 affected156 at risk EG00210 affected156 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected317 at risk EG0019 affected156 at risk EG00210 affected156 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected317 at risk EG0018 affected156 at risk EG00211 affected156 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00020 affected317 at risk EG00115 affected156 at risk EG0026 affected156 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected317 at risk EG0016 affected156 at risk EG0026 affected156 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00070 affected317 at risk EG00146 affected156 at risk EG00239 affected156 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00076 affected317 at risk EG00129 affected156 at risk EG00231 affected156 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00031 affected317 at risk EG00118 affected156 at risk EG0028 affected156 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00024 affected317 at risk EG0015 affected156 at risk EG0028 affected156 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected317 at risk EG0018 affected156 at risk EG0029 affected156 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected317 at risk EG0017 affected156 at risk EG0024 affected156 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00085 affected317 at risk EG00138 affected156 at risk EG00239 affected156 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00053 affected317 at risk EG00131 affected156 at risk EG00227 affected156 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00038 affected317 at risk EG00124 affected156 at risk EG00227 affected156 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00037 affected317 at risk EG00124 affected156 at risk EG00214 affected156 at risk EG003
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG000117 affected317 at risk EG00168 affected156 at risk EG00256 affected156 at risk EG003
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00032 affected317 at risk EG00115 affected156 at risk EG00217 affected156 at risk EG003
Disturbance in attention	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00014 affected317 at risk EG00110 affected156 at risk EG0028 affected156 at risk EG003
Tremor	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected317 at risk EG0018 affected156 at risk EG0023 affected156 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00099 affected317 at risk EG00146 affected156 at risk EG00247 affected156 at risk EG003
Depression	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00056 affected317 at risk EG00120 affected156 at risk EG00229 affected156 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected317 at risk EG0015 affected156 at risk EG00212 affected156 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG00014 affected317 at risk EG0019 affected156 at risk EG0027 affected156 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00062 affected317 at risk EG00126 affected156 at risk EG00233 affected156 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00033 affected317 at risk EG00119 affected156 at risk EG00219 affected156 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00024 affected317 at risk EG0019 affected156 at risk EG0026 affected156 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected317 at risk EG0015 affected156 at risk EG0028 affected156 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00048 affected317 at risk EG00132 affected156 at risk EG00227 affected156 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00033 affected317 at risk EG00117 affected156 at risk EG00213 affected156 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00020 affected317 at risk EG00111 affected156 at risk EG0026 affected156 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00070 affected317 at risk EG00125 affected156 at risk EG00228 affected156 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected317 at risk EG0015 affected156 at risk EG0022 affected156 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00017 affected317 at risk EG0016 affected156 at risk EG0025 affected156 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00017 affected317 at risk EG0018 affected156 at risk EG0027 affected156 at risk EG003
Upper respiratory tract Infection	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00015 affected317 at risk EG0018 affected156 at risk EG00211 affected156 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG00012 affected317 at risk EG00111 affected156 at risk EG0023 affected156 at risk EG003
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00031 affected317 at risk EG0016 affected156 at risk EG00215 affected156 at risk EG003
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected317 at risk EG00111 affected156 at risk EG0028 affected156 at risk EG003
Vision blurred	Eye disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected317 at risk EG0018 affected156 at risk EG0026 affected156 at risk EG003

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
		Mobile	Alabama	36693	United States

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