Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experie... | NCT01467492

Label	Type	Description	Intervention Names
Black	Experimental	Telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.	Drug: Telaprevir Drug: Ribavirin Biological: Pegylated Interferon Alfa-2a
Non-Black	Experimental	Telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.	Drug: Telaprevir Drug: Ribavirin Biological: Pegylated Interferon Alfa-2a

Name	Type	Description	Arm Group Labels	Other Names
Telaprevir	Drug	Tablet	Black Non-Black	Incivek, VX-950

Measure	Description	Time Frame
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)	SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\	12 weeks after last actual dose of study drug (up to Week 60)

Measure	Description	Time Frame
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)	SVR24 was defined as an undetectable HCV RNA Levels (\	24 weeks after last actual dose of study drug (up to Week 72)

Measure	Description	Time Frame
Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)		48 weeks

Name	Affiliation	Role
Medical Monitor	Vertex Pharmaceuticals Incorporated	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama		Birmingham	Alabama		United States
California

ID	Title	Description
FG000	Group A - Black	Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)

SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\

FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

Posted

Number

percentage of participants

12 weeks after last actual dose of study drug (up to Week 60)

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Units	Counts
Participants	OG00082 OG00138

Title

Denominators

Categories

Prior Null Response (n = 41, 10)

Title	Measurements
	OG00026.8 OG00120.0

Prior Partial Response (n= 20, 6)

Title	Measurements
	OG000

Secondary

Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)

SVR24 was defined as an undetectable HCV RNA Levels (\

FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

Posted

Number

percentage of participants

24 weeks after last actual dose of study drug (up to Week 72)

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Percentage of Participants With Extended Rapid Viral Response (eRVR)

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\

FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.

Posted

Number

percentage of participants

Week 4 and Week 12

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Percentage of Participants With Relapse

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (>=lower limit of quantification) during follow-up.

FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA \

Posted

Number

percentage of participants

4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Percentage of Participants With Virologic Breakthrough

The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (>=lower limit of quantification) after undetectable HCV RNA (\

FA Set.

Posted

Number

percentage of participants

Week 2, 4, 8, and 12

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Percentage of Participants With On Treatment Virologic Failure

On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA >1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.

FA Set.

Posted

Number

percentage of participants

Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.

Safety Set.

Posted

Number

percentage of participants

Up to Week 52

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Secondary

Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA >=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.

FA Set.

Posted

Number

participants

up to Week 72

ID	Title	Description
OG000	All Participants	All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Units	Counts
Participants	OG000

Other Pre-specified

Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)

Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.

Posted

48 weeks

ID	Title	Description
OG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
OG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0012 affected38 at risk
Warm type haemolytic anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Salmonellosis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Accelerated hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fatigue	General disorders	MedDRA 17.0	Systematic Assessment	EG00031 affected82 at risk EG00126 affected38 at risk
Influenza like illness	General disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected82 at risk EG0017 affected38 at risk
Injection site erythema	General disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected82 at risk EG0014 affected38 at risk
Chills	General disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0014 affected38 at risk
Pyrexia	General disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected82 at risk EG0013 affected38 at risk
Injection site rash	General disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0012 affected38 at risk
Asthenia	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0013 affected38 at risk
Malaise	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0011 affected38 at risk
Oedema peripheral	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0011 affected38 at risk
Pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0013 affected38 at risk
Chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Adverse drug reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Chest discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Crying	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Feeling abnormal	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Feeling jittery	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Injection site bruising	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Injection site discolouration	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Injection site discomfort	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Injection site reaction	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Local swelling	General disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00020 affected82 at risk EG00117 affected38 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG00016 affected82 at risk EG0015 affected38 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected82 at risk EG0017 affected38 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0015 affected38 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0014 affected38 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0013 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0014 affected38 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0013 affected38 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0011 affected38 at risk
Constipation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0014 affected38 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0012 affected38 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0010 affected38 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0010 affected38 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0012 affected38 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0013 affected38 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0011 affected38 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0012 affected38 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0012 affected38 at risk
Tongue discolouration	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Dental caries	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Eructation	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Oral lichen planus	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Retching	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Toothache	Gastrointestinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG00033 affected82 at risk EG00116 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG00015 affected82 at risk EG00113 affected38 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected82 at risk EG0012 affected38 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected82 at risk EG0012 affected38 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected82 at risk EG0011 affected38 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected82 at risk EG0011 affected38 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Skin fissures	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Drug reaction with eosinophilia and systemic symptoms	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Lichen planus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Pigmentation disorder	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Skin hyperpigmentation	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG00040 affected82 at risk EG00119 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0009 affected82 at risk EG0012 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0012 affected38 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0012 affected38 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG00014 affected82 at risk EG00113 affected38 at risk
Dizziness	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected82 at risk EG0018 affected38 at risk
Dysgeusia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0013 affected38 at risk
Disturbance in attention	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0012 affected38 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0011 affected38 at risk
Paraesthesia	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0010 affected38 at risk
Burning sensation	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Lethargy	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Presyncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Sinus headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Syncope	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Tension headache	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Tremor	Nervous system disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG00110 affected38 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0014 affected38 at risk
Irritability	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected82 at risk EG0014 affected38 at risk
Anxiety	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0012 affected38 at risk
Sleep disorder	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0013 affected38 at risk
Mood swings	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Alcoholism	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Confusional state	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Hallucination	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Initial insomnia	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Panic attack	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Restlessness	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Stress	Psychiatric disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG00010 affected82 at risk EG0014 affected38 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0017 affected38 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0011 affected38 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0005 affected82 at risk EG0013 affected38 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0012 affected38 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0011 affected38 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG00011 affected82 at risk EG0017 affected38 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0008 affected82 at risk EG0013 affected38 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0006 affected82 at risk EG0011 affected38 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Sinusitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0011 affected38 at risk
Cellulitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0011 affected38 at risk
Candida infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0010 affected38 at risk
Conjunctivitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0012 affected38 at risk
Herpes zoster	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Hordeolum	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Influenza	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Carbuncle	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Ear infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Fungal skin infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Furuncle	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Helicobacter gastritis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Herpes simplex	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Localised infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Oral candidiasis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Otitis externa	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Pneumonia	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Staphylococcal abscess	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Tinea cruris	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Tinea infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Vulvovaginal candidiasis	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG00011 affected82 at risk EG0014 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0007 affected82 at risk EG0011 affected38 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Vision blurred	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0013 affected38 at risk
Abnormal sensation in eye	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Eye pain	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Vitreous floaters	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Dry eye	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Eye pruritus	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Photophobia	Eye disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Weight decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0012 affected38 at risk
Blood creatinine increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Cardiac murmur	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Platelet count decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Amylase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Blood thyroid stimulating hormone decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Blood uric acid increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Blood urine present	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Haemoglobin decreased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Hepatic enzyme increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Lipase increased	Investigations	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0012 affected38 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Palpitations	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0012 affected38 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0003 affected82 at risk EG0011 affected38 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Genital rash	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Penile discharge	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Penis disorder	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Hypertension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0004 affected82 at risk EG0010 affected38 at risk
Flushing	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Pallor	Vascular disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0011 affected38 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0012 affected38 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Transitional cell cancer of the renal pelvis and ureter	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Haematuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0002 affected82 at risk EG0010 affected38 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Renal pain	Renal and urinary disorders	MedDRA 17.0	Systematic Assessment	EG0000 affected82 at risk EG0011 affected38 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0011 affected38 at risk
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 17.0	Systematic Assessment	EG0001 affected82 at risk EG0010 affected38 at risk

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

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

ID	Title	Description
BG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
BG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A - Black	Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.			7	82	79	82
EG001	Group B - Non-Black	Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.			6	38	38	38

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