Efficacy and Safety of Alisporivir Triple Therapy in Chro... | NCT01318694

NCT01318694

ID	Type	Description	Link
2010-022867-37	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Arm A	Experimental	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT): Participants with a viral load below the level of detection (< LOD) at Week 4 stop study treatment after 24 weeks Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment	Drug: Alisporivir Drug: Peginterferon alfa-2a Drug: Ribavirin
Treatment Arm B	Experimental	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)	Drug: Alisporivir Drug: Peginterferon alfa-2a Drug: Ribavirin
Treatment Arm C	Experimental	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks	Drug: Alisporivir Drug: Peginterferon alfa-2a Drug: Ribavirin
Treatment Arm D	Active Comparator	ALV Placebo with PEG and RBV for 48 weeks	Drug: Peginterferon alfa-2a Drug: Ribavirin Drug: ALV Placebo

Name	Type	Description	Arm Group Labels	Other Names
Alisporivir	Drug	ALV 200 mg soft gel capsules administered orally	Treatment Arm A Treatment Arm B Treatment Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12)	SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment.	12 weeks after the end of treatment

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)	SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.	24 weeks after the end of treatment
Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Beverly Hills	California	90211	United States
Novartis Investigative Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment Arm A	Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
FG001	Treatment Arm B

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
BG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
BG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
BG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00068.6 OG00168.9 OG00269.4 OG003

Secondary

Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)

SVR24 was defined as HCV RNA laboratory value < LOQ 24 weeks after the end of treatment.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

24 weeks after the end of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4)

RVR4 was defined as serum HCV RNA < LOQ after 4 weeks of treatment.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

after 4 weeks of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment

EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA < LOQ after 12 weeks of treatment.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

after 12 weeks of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment

pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

after 12 weeks of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment

cEVR was defined as serum HCV RNA < LOQ after 12 weeks of treatment.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

after 12 weeks of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment

eRVR was defined as achieving RVR4 and maintaining HCV RNA < LOQ until Week 12.

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

from 4 to 12 weeks of treatment

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks

ETR was defined as serum HCV RNA < LOQ at treatment end (completed or prematurely discontinued).

Participants in the Full Analysis Set with available data

Posted

Number

percentage of participants

at treatment end within 48 weeks

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks

ALT abnormalities were summarized as participants who had either:

ALT > 2 x upper limit of normal (ULN) during the study and > 2 x ULN at baseline
ALT > 3 x ULN during the study and > 2 x ULN at baseline

Participants in the Safety Set, defined as having received at least one dose of study medication, with available data

Posted

Number

percentage of participants

within 48 weeks

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks

Grading was according to the Modified Division of Microbiology & Infectious Diseases (DMID) Toxicity Tables (version 2.0).

Participants with multiple abnormalities were counted only once in the worst category.

Participants in the Safety Set with available data

Posted

Number

percentage of participants

within 48 weeks

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Participants in the Safety Set with available data

Posted

Number

percentage of participants

within 48 weeks

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Secondary

Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks

Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category.

Participants in the Safety Set with available data

Posted

Number

percentage of participants

within 48 weeks

ID	Title	Description
OG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
OG001	Treatment Arm B	Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
OG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
OG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Arm A	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT	24	273	256	273
EG001	Treatment Arm B	Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)	28	268	261	268
EG002	Treatment Arm C	Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks	21	265	250	265
EG003	Treatment Arm D	ALV Placebo with PEG and RBV for 48 weeks	28	265	242	265

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG0032 affected265 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0002 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Thyroiditis	Endocrine disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0022 affected265 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Dacryoadenitis acquired	Eye disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0013 affected268 at risk EG0021 affected265 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0012 affected268 at risk EG0020 affected265 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0012 affected268 at risk EG0020 affected265 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Pyrexia	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0012 affected268 at risk EG0020 affected265 at risk EG003
Drug interaction	General disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Fatigue	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Influenza like illness	General disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Lipogranuloma	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Multi-organ failure	General disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pain	General disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Appendicitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Bronchitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0012 affected268 at risk EG0020 affected265 at risk EG003
Pneumonia	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0011 affected268 at risk EG0021 affected265 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0002 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Cellulitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Cervicitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Enterocolitis infectious	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Influenza	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Nasal abscess	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Salpingo-oophoritis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Craniopharyngioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Squamous cell carcinoma of the cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Dizziness	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Headache	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0021 affected265 at risk EG003
Subarachnoid haemorrhage	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Syncope	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Intraventricular haemorrhage	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Depression	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Mania	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0012 affected268 at risk EG0020 affected265 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Major depression	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Bartholinitis	Reproductive system and breast disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Ovarian disorder	Reproductive system and breast disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0022 affected265 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0013 affected268 at risk EG0020 affected265 at risk EG003
Hypertension	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0021 affected265 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0011 affected268 at risk EG0020 affected265 at risk EG003
Hypotension	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0001 affected273 at risk EG0010 affected268 at risk EG0020 affected265 at risk EG003
Vasculitis	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG0000 affected273 at risk EG0010 affected268 at risk EG0021 affected265 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG000113 affected273 at risk EG001124 affected268 at risk EG00291 affected265 at risk EG00388 affected265 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG00048 affected273 at risk EG00127 affected268 at risk EG00248 affected265 at risk EG003
Lymphopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG00015 affected273 at risk EG0017 affected268 at risk EG00216 affected265 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG00086 affected273 at risk EG00180 affected268 at risk EG00286 affected265 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.0)	Systematic Assessment	EG00047 affected273 at risk EG00173 affected268 at risk EG00249 affected265 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (16.0)	Systematic Assessment	EG00017 affected273 at risk EG00122 affected268 at risk EG00223 affected265 at risk EG003
Ocular icterus	Eye disorders	MedDRA (16.0)	Systematic Assessment	EG00011 affected273 at risk EG00114 affected268 at risk EG0025 affected265 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00018 affected273 at risk EG00124 affected268 at risk EG00222 affected265 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00012 affected273 at risk EG00117 affected268 at risk EG0027 affected265 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00030 affected273 at risk EG00127 affected268 at risk EG00238 affected265 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00023 affected273 at risk EG00117 affected268 at risk EG00232 affected265 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00011 affected273 at risk EG0019 affected268 at risk EG0027 affected265 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00066 affected273 at risk EG00167 affected268 at risk EG00262 affected265 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Systematic Assessment	EG00026 affected273 at risk EG00139 affected268 at risk EG00229 affected265 at risk EG003
Asthenia	General disorders	MedDRA (16.0)	Systematic Assessment	EG00043 affected273 at risk EG00146 affected268 at risk EG00246 affected265 at risk EG003
Chills	General disorders	MedDRA (16.0)	Systematic Assessment	EG00023 affected273 at risk EG00130 affected268 at risk EG00233 affected265 at risk EG003
Fatigue	General disorders	MedDRA (16.0)	Systematic Assessment	EG00084 affected273 at risk EG00199 affected268 at risk EG00287 affected265 at risk EG003
Influenza like illness	General disorders	MedDRA (16.0)	Systematic Assessment	EG00056 affected273 at risk EG00152 affected268 at risk EG00238 affected265 at risk EG003
Injection site erythema	General disorders	MedDRA (16.0)	Systematic Assessment	EG00014 affected273 at risk EG00110 affected268 at risk EG00217 affected265 at risk EG003
Irritability	General disorders	MedDRA (16.0)	Systematic Assessment	EG00019 affected273 at risk EG00116 affected268 at risk EG00221 affected265 at risk EG003
Pyrexia	General disorders	MedDRA (16.0)	Systematic Assessment	EG00078 affected273 at risk EG00193 affected268 at risk EG00282 affected265 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG00032 affected273 at risk EG00161 affected268 at risk EG00225 affected265 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA (16.0)	Systematic Assessment	EG0007 affected273 at risk EG00120 affected268 at risk EG0023 affected265 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG0009 affected273 at risk EG0019 affected268 at risk EG00217 affected265 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG00016 affected273 at risk EG0015 affected268 at risk EG00216 affected265 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (16.0)	Systematic Assessment	EG00011 affected273 at risk EG00114 affected268 at risk EG00211 affected265 at risk EG003
Weight decreased	Investigations	MedDRA (16.0)	Systematic Assessment	EG00024 affected273 at risk EG00128 affected268 at risk EG00226 affected265 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG00061 affected273 at risk EG00159 affected268 at risk EG00258 affected265 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA (16.0)	Systematic Assessment	EG00011 affected273 at risk EG00123 affected268 at risk EG00222 affected265 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00038 affected273 at risk EG00135 affected268 at risk EG00239 affected265 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00018 affected273 at risk EG00114 affected268 at risk EG00215 affected265 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG0008 affected273 at risk EG00117 affected268 at risk EG0027 affected265 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00059 affected273 at risk EG00153 affected268 at risk EG00256 affected265 at risk EG003
Dizziness	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG00033 affected273 at risk EG00134 affected268 at risk EG00225 affected265 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG00014 affected273 at risk EG00122 affected268 at risk EG00213 affected265 at risk EG003
Headache	Nervous system disorders	MedDRA (16.0)	Systematic Assessment	EG00091 affected273 at risk EG00194 affected268 at risk EG00294 affected265 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG00017 affected273 at risk EG00120 affected268 at risk EG00225 affected265 at risk EG003
Depression	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG00020 affected273 at risk EG00129 affected268 at risk EG00228 affected265 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (16.0)	Systematic Assessment	EG00049 affected273 at risk EG00161 affected268 at risk EG00250 affected265 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00047 affected273 at risk EG00154 affected268 at risk EG00259 affected265 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00037 affected273 at risk EG00126 affected268 at risk EG00223 affected265 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00012 affected273 at risk EG00125 affected268 at risk EG00215 affected265 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Systematic Assessment	EG00015 affected273 at risk EG00113 affected268 at risk EG00219 affected265 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00060 affected273 at risk EG00145 affected268 at risk EG00257 affected265 at risk EG003
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00021 affected273 at risk EG00123 affected268 at risk EG00231 affected265 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00058 affected273 at risk EG00155 affected268 at risk EG00249 affected265 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Systematic Assessment	EG00046 affected273 at risk EG00140 affected268 at risk EG00245 affected265 at risk EG003
Hypertension	Vascular disorders	MedDRA (16.0)	Systematic Assessment	EG00031 affected273 at risk EG00150 affected268 at risk EG00234 affected265 at risk EG003

Ancestor Terms

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
D006521	Hepatitis, Chronic
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006526	Hepatitis C
D019698	Hepatitis C, Chronic

ID	Term
C499715	alisporivir
C100416	peginterferon alfa-2a
D012254	Ribavirin

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