Safety and Efficacy of Boceprevir in Previously Untreated... | NCT00705432

ID	Type	Description	Link
EUDRACT # 2007-005508-42

Label	Type	Description	Intervention Names
1. Placebo + PEG + RBV	Placebo Comparator	PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks (lead in treatment) followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.	Biological: Peginterferon alfa-2b (PEG) Drug: Ribavirin (RBV) Drug: Placebo
2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Experimental	PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable from Treatment Weeks 8 to Treatment Week 24, will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.	Biological: Peginterferon alfa-2b (PEG) Drug: Ribavirin (RBV) Drug: Boceprevir
3. Boceprevir + PEG + RBV - 44 Weeks	Experimental	PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.	Biological: Peginterferon alfa-2b (PEG) Drug: Ribavirin (RBV) Drug: Boceprevir

Name	Type	Description	Arm Group Labels	Other Names
Peginterferon alfa-2b (PEG)	Biological	Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC)	1. Placebo + PEG + RBV 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Measure	Description	Time Frame
Sustained Virologic Response (SVR) Rate	Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.	At Follow-up Week (FW) 24

Measure	Description	Time Frame
Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)	Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate was the percentage of participants treated with at least one dose of boceprevir or placebo who had achieved SVR. HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant must have previously documented CHC genotype 1 infection.
Participant must have a liver biopsy with histology consistent with CHC and no other etiology.
Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
Participant must be >=18 years of age.
Participant must weigh between 40 kg and 125 kg.
Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
Participants must be willing to give written informed consent.

Exclusion Criteria:

Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
Participants who received prior treatment for hepatitis C; other than herbal remedies, except those with known hepatotoxicity.
Treatment with any investigational drug within 30 days of the randomization visit in this study.
Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study.
Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
Diabetic and/or hypertensive participants with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.
Pre-existing psychiatric condition(s).
Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes.
Any known pre-existing medical condition that could interfere with the participant's participation in and completion of the study.
Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Participants under evaluation for malignancy are not eligible.
Participants who are pregnant or nursing. Participants who intend to become pregnant during the study period. Male participants with partners who are, or intend to become, pregnant during the study period.
Any other condition which, in the opinion of a physician, would make the participant unsuitable for enrollment or could interfere with the participant participating in and completing the study.
Participants who are part of the site personnel directly involved with this study.
Participants who are family members of the investigational study staff.
Participants who had life-threatening serious adverse event (SAE) during screening period.
Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN)
Serum albumin < lower limit of normal (LLN)
Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain exceptions.
Serum creatinine >ULN of the laboratory reference.
Protocol-specified serum glucose concentrations.
protocol-specified alpha fetoprotein levels.
Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range.
Anti-nuclear antibodies (ANA) >1:320.

PubMed Identifier	Type	Citation	Retractions
23621902	Derived	Ferrante SA, Chhatwal J, Brass CA, El Khoury AC, Poordad F, Bronowicki JP, Elbasha EH. Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study. BMC Infect Dis. 2013 Apr 27;13:190. doi: 10.1186/1471-2334-13-190.
22626609	Derived

ID	Title	Description
FG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
FG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)

Arm/Group Information

ID	Title	Description
BG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
BG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
BG002	Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
BG003	Cohort II - 1. Placebo + PEG + RBV	Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
BG004	Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
BG005	Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks	Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
BG006	Total	Total of all reporting groups

Units	Counts
Participants	BG000311 BG001316 BG002311 BG00352 BG00452 BG00555 BG0061097

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

Sustained Virologic Response (SVR) Rate

Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR.

HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.

If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.

Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).

Posted

Number

Percentage of participants

At Follow-up Week (FW) 24

ID	Title	Description
OG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
OG002	Cohort I - 3. Boceprevir + PEG + RBV - 44 Weeks	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG003	Cohort II - 1. Placebo + PEG + RBV	Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG004	Cohort II - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.
OG005	Cohort II - 3. Boceprevir + PEG + RBV - 44 Weeks	Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.

Units	Counts
Participants	OG000311 OG001316 OG002311 OG003

Title

Denominators

Categories

Title	Measurements
	OG00040.2 OG00166.8 OG00268.5 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel Haenszel Chi-square test	Adjustments were made for for baseline stratification factors: viral load (>400,000 vs. ≤400,000 IU/mL) and Genotype (1a vs 1b).	<0.0001		The difference in SVR	26.6			2-Sided	95	19.1	34.1					Superiority or Other
OG000 OG002

Secondary

Sustained Virologic Response (SVR) Rate in Participants Treated With Study Drug (Boceprevir or Placebo)

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have a SVR.

Modified intent-to-treat set (mITT). All randomized participants who received at least one dose of boceprevir or placebo.

Posted

Number

Percentage of participants

At FW 24

ID	Title	Description
OG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.

Secondary

Number of Participants With Undetectable HCV-RNA at Follow-up Week 12 and at 72 Weeks After Randomization.

Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. The number of participants who had undetectable plasma HCV-RNA at FW 12, and 72 weeks after randomization are reported.

HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL.

Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).

Posted

Number

Participants

At FW 12 and at 72 weeks after randomization

ID	Title	Description
OG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.

Secondary

Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 2, 4, 8, 12, 16, or 20)

Early virologic response was defined as undetectable HCV-RNA at in participants by treatment week 2, 4, 8, 12, 16, or 20.

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

Full analysis set (FAS). All randomized participants who received at least one dose of any study medication (PEG, RBV or boceprevir).

Posted

Number

Participants

At Treatment Week 2, 4, 8, 12, 16, or 20

ID	Title	Description
OG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.

Secondary

Number of Participants With Early Virologic Response (Undetectable HCV-RNA at Treatment Week 4, 8, 12, 16, or 20) Who Achieved SVR

Participants with early virologic response were those who had undetectable HCV-RNA by treatment week 4, 8, 12, 16, or 20. Participants who had undetectable plasma HCV-RNA at FW 24 had SVR. The number of participants with early virologic response that also achieved SVR is reported.

HCV-RNA in participant's plasma samples was detected by a nucleic acid amplification assay with a limit of detection of 9.3 IU/mL.

Participants that had undetectable HCV RNA for the treatment weeks 4, 8, 12, 16, and 20.

Posted

Number

Participants

At Treatment Week 4, 8, 12, 16, 20

ID	Title	Description
OG000	Cohort I - 1. Placebo + PEG + RBV	Cohort I (White participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.
OG001	Cohort I - 2. Boceprevir + PEG + RBV - 24 Weeks (RGT)	Cohort I (White participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0015 events3 affected368 at risk EG0027 events4 affected366 at risk
APLASIA PURE RED CELL	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0022 events2 affected366 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0023 events2 affected366 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0023 events3 affected366 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
HYPERTROPHIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
DEAFNESS	Ear and labyrinth disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
OPTIC NEUROPATHY	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
PAPILLOEDEMA	Eye disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0011 events1 affected368 at risk EG0021 events1 affected366 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
COLITIS	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
VOMITING	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0022 events2 affected366 at risk
CHEST DISCOMFORT	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0022 events2 affected366 at risk
CHEST PAIN	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0024 events4 affected366 at risk
DEATH	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
FATIGUE	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
MALAISE	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
PYREXIA	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected363 at risk EG0011 events1 affected368 at risk EG0023 events3 affected366 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
CHOLELITHIASIS OBSTRUCTIVE	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
SARCOIDOSIS	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0022 events1 affected366 at risk
ABSCESS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
APPENDICITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
ATYPICAL MYCOBACTERIAL INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
BACTERAEMIA	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
BRONCHITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0012 events2 affected368 at risk EG0020 events0 affected366 at risk
CELLULITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0011 events1 affected368 at risk EG0022 events2 affected366 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
ENTEROCOLITIS INFECTIOUS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
EPIGLOTTITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0012 events2 affected368 at risk EG0022 events2 affected366 at risk
INFECTED BITES	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
INJECTION SITE INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
PNEUMONIA	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0014 events3 affected368 at risk EG0021 events1 affected366 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
SCROTAL ABSCESS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
SINUSITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
TRACHEOBRONCHITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0022 events1 affected366 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
TRANSFUSION REACTION	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0012 events2 affected368 at risk EG0020 events0 affected366 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
CEREBRAL ISCHAEMIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
DIZZINESS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0022 events1 affected366 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
MOTOR NEURONE DISEASE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
MUSCLE SPASTICITY	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
SYNCOPE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0024 events4 affected366 at risk
AFFECTIVE DISORDER	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
ANXIETY	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
BIPOLAR I DISORDER	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
DEPRESSION	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0011 events1 affected368 at risk EG0021 events1 affected366 at risk
DRUG ABUSE	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
DRUG DEPENDENCE	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
INTENTIONAL SELF-INJURY	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
PERSONALITY DISORDER	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
PSYCHIATRIC DECOMPENSATION	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0024 events4 affected366 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
GLOMERULONEPHRITIS MINIMAL LESION	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
SCROTAL PAIN	Reproductive system and breast disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0022 events2 affected366 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
PLEURAL FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0020 events0 affected366 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0012 events2 affected368 at risk EG0020 events0 affected366 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
RASH ERYTHEMATOUS	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
ALCOHOL USE	Social circumstances	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
PHYSICAL ASSAULT	Social circumstances	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
CHOLECYSTECTOMY	Surgical and medical procedures	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
LARYNGEAL OPERATION	Surgical and medical procedures	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
SKIN NEOPLASM EXCISION	Surgical and medical procedures	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected363 at risk EG0010 events0 affected368 at risk EG0020 events0 affected366 at risk
ACCELERATED HYPERTENSION	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
ARTERIAL THROMBOSIS LIMB	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0010 events0 affected368 at risk EG0021 events1 affected366 at risk
HYPOTENSION	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected363 at risk EG0011 events1 affected368 at risk EG0021 events1 affected366 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG000188 events107 affected363 at risk EG001292 events182 affected368 at risk EG002352 events179 affected366 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00081 events33 affected363 at risk EG00183 events31 affected368 at risk EG002126 events45 affected366 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG000208 events77 affected363 at risk EG001216 events91 affected368 at risk EG002257 events93 affected366 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 13.0	Systematic Assessment	EG00016 events7 affected363 at risk EG00150 events16 affected368 at risk EG00238 events19 affected366 at risk
DRY EYE	Eye disorders	MedDRA 13.0	Systematic Assessment	EG00016 events16 affected363 at risk EG00113 events13 affected368 at risk EG00224 events22 affected366 at risk
VISION BLURRED	Eye disorders	MedDRA 13.0	Systematic Assessment	EG00015 events14 affected363 at risk EG00125 events23 affected368 at risk EG00225 events22 affected366 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00030 events20 affected363 at risk EG00128 events25 affected368 at risk EG00228 events23 affected366 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00040 events32 affected363 at risk EG00141 events30 affected368 at risk EG00254 events44 affected366 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00034 events32 affected363 at risk EG00124 events22 affected368 at risk EG00234 events32 affected366 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG000103 events79 affected363 at risk EG001104 events80 affected368 at risk EG002125 events100 affected366 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00045 events40 affected363 at risk EG00142 events39 affected368 at risk EG00251 events43 affected366 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00039 events32 affected363 at risk EG00135 events29 affected368 at risk EG00240 events33 affected366 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0009 events8 affected363 at risk EG00122 events19 affected368 at risk EG00222 events20 affected366 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG000199 events153 affected363 at risk EG001231 events175 affected368 at risk EG002212 events159 affected366 at risk
VOMITING	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG00070 events57 affected363 at risk EG00199 events75 affected368 at risk EG00290 events70 affected366 at risk
ASTHENIA	General disorders	MedDRA 13.0	Systematic Assessment	EG000129 events70 affected363 at risk EG00186 events55 affected368 at risk EG002132 events70 affected366 at risk
CHILLS	General disorders	MedDRA 13.0	Systematic Assessment	EG000114 events102 affected363 at risk EG001156 events134 affected368 at risk EG002139 events121 affected366 at risk
FATIGUE	General disorders	MedDRA 13.0	Systematic Assessment	EG000279 events217 affected363 at risk EG001250 events196 affected368 at risk EG002290 events209 affected366 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 13.0	Systematic Assessment	EG000160 events93 affected363 at risk EG001113 events91 affected368 at risk EG002102 events83 affected366 at risk
INJECTION SITE ERYTHEMA	General disorders	MedDRA 13.0	Systematic Assessment	EG00055 events47 affected363 at risk EG00148 events46 affected368 at risk EG00238 events37 affected366 at risk
INJECTION SITE REACTION	General disorders	MedDRA 13.0	Systematic Assessment	EG00046 events44 affected363 at risk EG00146 events45 affected368 at risk EG00239 events39 affected366 at risk
IRRITABILITY	General disorders	MedDRA 13.0	Systematic Assessment	EG000106 events86 affected363 at risk EG001104 events81 affected368 at risk EG002111 events83 affected366 at risk
PAIN	General disorders	MedDRA 13.0	Systematic Assessment	EG00036 events34 affected363 at risk EG00143 events41 affected368 at risk EG00241 events37 affected366 at risk
PYREXIA	General disorders	MedDRA 13.0	Systematic Assessment	EG000196 events120 affected363 at risk EG001180 events123 affected368 at risk EG002218 events117 affected366 at risk
SINUSITIS	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG00018 events15 affected363 at risk EG00120 events16 affected368 at risk EG00222 events19 affected366 at risk
WEIGHT DECREASED	Investigations	MedDRA 13.0	Systematic Assessment	EG00054 events46 affected363 at risk EG00150 events43 affected368 at risk EG00264 events52 affected366 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 13.0	Systematic Assessment	EG000101 events90 affected363 at risk EG001107 events97 affected368 at risk EG00298 events89 affected366 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00084 events66 affected363 at risk EG00187 events69 affected368 at risk EG002103 events72 affected366 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00045 events40 affected363 at risk EG00133 events30 affected368 at risk EG00245 events40 affected366 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00025 events23 affected363 at risk EG00120 events15 affected368 at risk EG00220 events18 affected366 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG000125 events94 affected363 at risk EG00198 events78 affected368 at risk EG002120 events92 affected366 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00021 events19 affected363 at risk EG00112 events11 affected368 at risk EG00224 events21 affected366 at risk
DISTURBANCE IN ATTENTION	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00030 events27 affected363 at risk EG00123 events22 affected368 at risk EG00218 events18 affected366 at risk
DIZZINESS	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00074 events59 affected363 at risk EG00197 events80 affected368 at risk EG00270 events66 affected366 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00068 events64 affected363 at risk EG001143 events137 affected368 at risk EG002164 events156 affected366 at risk
HEADACHE	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG000264 events153 affected363 at risk EG001233 events168 affected368 at risk EG002311 events167 affected366 at risk
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00021 events21 affected363 at risk EG0019 events9 affected368 at risk EG00228 events24 affected366 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG00032 events13 affected363 at risk EG00111 events10 affected368 at risk EG00223 events19 affected366 at risk
ANXIETY	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG00049 events42 affected363 at risk EG00157 events50 affected368 at risk EG00265 events48 affected366 at risk
DEPRESSION	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG00086 events78 affected363 at risk EG001103 events82 affected368 at risk EG00285 events69 affected366 at risk
INSOMNIA	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG000137 events118 affected363 at risk EG001145 events117 affected368 at risk EG002141 events122 affected366 at risk
MOOD SWINGS	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0007 events6 affected363 at risk EG00117 events13 affected368 at risk EG00221 events19 affected366 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00087 events76 affected363 at risk EG00169 events56 affected368 at risk EG002100 events74 affected366 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00066 events59 affected363 at risk EG00187 events68 affected368 at risk EG00294 events84 affected366 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00033 events30 affected363 at risk EG00144 events42 affected368 at risk EG00239 events31 affected366 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00015 events13 affected363 at risk EG00123 events19 affected368 at risk EG00221 events21 affected366 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG00024 events22 affected363 at risk EG00118 events14 affected368 at risk EG00234 events33 affected366 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG000105 events99 affected363 at risk EG00182 events75 affected368 at risk EG002109 events104 affected366 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG00077 events66 affected363 at risk EG00172 events67 affected368 at risk EG00298 events86 affected366 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG000130 events98 affected363 at risk EG001101 events87 affected368 at risk EG002138 events94 affected366 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG000124 events83 affected363 at risk EG001111 events93 affected368 at risk EG002119 events88 affected366 at risk

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
C417083	peginterferon alfa-2b
D012254	Ribavirin
C512204	N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	PEG + RBV	Cohort I (White participants) and Cohort II (Black participants) treated with PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing [WBD]) for 4 weeks followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.	31	363	353	363
EG001	BOCEPREVIR + PEG + RBV - 24 WEEKS	Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable at Treatment Week 8 and at all subsequent assays (up to Treatment Week 24), will proceed to the 44-week follow-up. At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up.	42	368	365	368
EG002	BOCEPRIVIR + PEG + RBV - 44 WEEKS	Cohort I (White participants) and Cohort II (Black participants) treated with PEG 1.5 μg/kg + RBV (WBD) for 4 weeks followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up.	45	366	363	366