Observational Study Evaluating the Quality of Pegylated I... | NCT02106156

Status Module

Label	Type	Description	Intervention Names
Chronic Hepatitis C		Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.	Drug: Pegylated interferon alfa-2a Drug: Ribavirin

Name	Type	Description	Arm Group Labels	Other Names
Pegylated interferon alfa-2a	Drug	Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).	Chronic Hepatitis C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Rapid Virologic Response (RVR)	RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.	At Week 4
Percentage of Participants With Early Virologic Response (EVR)	EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.	At Week 12
Percentage of Participants With End of Treatment (EOT) Response	EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.	Up to Week 72
Percentage of Participants With Sustained Virologic Response (SVR)	SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.	Up to Week 96
Percentage of Participants With Serious Adverse Drug Reactions (SADR)		Up to Week 96

Secondary Outcomes

Measure	Description	Time Frame
Percentage Cumulative Dose of Peginterferon Alfa-2a Received	Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

PubMed Identifier	Type	Citation	Retractions
25238535	Derived	Niederau C, Mauss S, Schober A, Stoehr A, Zimmermann T, Waizmann M, Moog G, Pape S, Weber B, Isernhagen K, Sandow P, Bokemeyer B, Alshuth U, Steffens H, Huppe D. Predictive factors for sustained virological response after treatment with pegylated interferon alpha-2a and ribavirin in patients infected with HCV genotypes 2 and 3. PLoS One. 2014 Sep 19;9(9):e107592. doi: 10.1371/journal.pone.0107592. eCollection 2014.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Main Analysis Set	Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
BG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
BG002	Elastography Analysis Set: Untreated	The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG0009620 BG00190 BG002518 BG00310228

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
	BG00042.2± 11.4 BG00144.9± 10.5 BG00251.1± 12.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003273 BG00123 BG002

Number of Participants With Each Hepatitis C Viral Genotype

Number

participants

Title

Denominators

Categories

Genotype 1

Title	Measurements
	BG0005699 BG00151 BG002

Number of Participants With Low or High Viral Load

Low viral load was defined as </=1,000,000 copies/milliliter (copies/ml) or </=400,000 international units/milliliter (IU/ml). High viral load was defined as >1,000,000 copies/ml or >400,000 IU/ml.

Number

participants

Title

Denominators

Categories

Low viral load

Title	Measurements
	BG0003769 BG001

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 Rapid Virologic Response (RVR)

RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.

Only treated participants were analyzed for this Outcome Measure. In each analysis set only those participants were included for whom a valid HCV PCR result was available or who discontinued from treatment before Week 4.

Posted

Number

percentage of participants

At Week 4

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Units	Counts
Participants	OG0006442 OG00160

Title

Denominators

Categories

Title	Measurements
	OG00040.0 OG00141.7

Primary

Percentage of Participants With Early Virologic Response (EVR)

EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.

Posted

Number

percentage of participants

At Week 12

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Units

Primary

Percentage of Participants With End of Treatment (EOT) Response

EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.

Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.

Posted

Number

percentage of participants

Up to Week 72

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Units	Counts

Primary

Percentage of Participants With Sustained Virologic Response (SVR)

SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.

Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.

Posted

Number

percentage of participants

Up to Week 96

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Primary

Percentage of Participants With Serious Adverse Drug Reactions (SADR)

Only treated participants were analyzed for this Outcome Measure. All participants within each analysis set were included in the analysis.

Posted

Number

percentage of participants

Up to Week 96

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Units	Counts
Participants

Secondary

Percentage Cumulative Dose of Peginterferon Alfa-2a Received

Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.

Posted

Median

Full Range

percentage of cumulated dose

Up to Week 96

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Secondary

Percentage Cumulative Dose of Ribavirin Received

Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.

Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.

Posted

Median

Full Range

percentage of cumulated dose

Up to Week 96

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Secondary

Duration of Peginterferon Alfa-2a Therapy

Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.

Only treated participants were analyzed for this Outcome Measure. Only participants with evaluable data for this Outcome Measure were included in the analysis.

Posted

Median

Full Range

weeks

Up to Week 72

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
OG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.

Units	Counts
Participants

Secondary

Percentage of Participants With the Most Frequent Concomitant Medications

Most frequent concomitant medications were defined as those, which were observed in >1 % of participants.

Only main analysis set had evaluable data for this outcome measure.

Posted

Number

percentage of participants

At Baseline (Day 1)

ID	Title	Description
OG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Main Analysis Set	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.	439	9,620	5,721	9,620
EG001	Elastography Analysis Set: Treated	Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.	4	90	82	90
EG002	Elastography Analysis Set: Untreated	Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.	0	518	0	518

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00035 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Autoimmune thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Granulocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haematotoxicity	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemorrhagic diathesis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00014 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected9,620 at risk EG0011 affected90 at risk EG0020 affected518 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Angina pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Arrhythmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cardiac failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cardiac perforation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Coronary artery disease	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Palpitations	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pericarditis	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Factor VIII deficiency	Congenital, familial and genetic disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intestinal atresia	Congenital, familial and genetic disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Ossicle disorder	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Basedow's disease	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hypothyroidism	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Eyelid oedema	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Retinal disorder	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Ascites	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Ileus	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Melaena	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Periodontitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Teeth brittle	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Tooth loss	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Chills	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Disease progression	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Drug ineffective	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
General physical health deterioration	General disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Generalised oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Granuloma	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Influenza like illness	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
No therapeutic response	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Serositis	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Sudden cardiac death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic artery occlusion	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Jaundice	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Decreased immune responsiveness	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Sarcoidosis	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Abscess jaw	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anal abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Appendicitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Bronchopneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Device related infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Empyema	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Endocarditis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Enterocolitis infectious	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Febrile infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Furuncle	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Groin abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatitis C	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Herpes zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
HIV infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Infectious pleural effusion	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Injection site abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intervertebral discitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Laryngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Latent tuberculosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Malaria	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Nasal vestibulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Oropharyngeal candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Otitis media	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pilonidal cyst	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00027 affected9,620 at risk EG0011 affected90 at risk EG0020 affected518 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pneumonia fungal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pyelonephritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Septic shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Tuberculosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Urosepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Accident	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Accident at home	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0006 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Shunt stenosis	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Therapeutic agent toxicity	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alanine aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Bilirubin conjugated increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Biopsy liver	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood bilirubin increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood cholinesterase decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood count abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood creatinine increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood glucose fluctuation	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood glucose increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Blood urea increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Electrocardiogram change	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemoglobin decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG00017 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Heart rate increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatitis C RNA increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Lymphocyte count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Platelet count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Prothrombin time prolonged	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Renal function test abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Transaminases increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Viral load increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Waist circumference increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Weight decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
White blood cell count decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Bursa disorder	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Muscle oedema	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Germ cell cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic neoplasm malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic neoplasm malignant resectable	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Seminoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Altered state of consciousness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Aphasia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Brain stem infarction	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Coma	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cubital tunnel syndrome	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dementia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dysarthria	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Encephalopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Facial paresis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hemianopia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hyperaesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Loss of consciousness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Multiple sclerosis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Nervous system disorder	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Paraesthesia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Polyneuropathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Acute psychosis	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Aggression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alcohol abuse	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alcohol problem	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Alcoholism	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00010 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anger	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Anxiety	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Completed suicide	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Confusional state	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Delirium	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dependence	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Depressed mood	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00020 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Drug dependence	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0008 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Psychotic disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00017 affected9,620 at risk EG0011 affected90 at risk EG0020 affected518 at risk
Schizophrenia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Sleep disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Suicidal ideation	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Suicide attempt	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Renal failure	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Urinary retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Breast induration	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Breast pain	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Scrotal ulcer	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Erythrodermic psoriasis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Rash generalised	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Skin discomfort	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Drug abuse	Social circumstances	MedDRA (15.0)	Systematic Assessment	EG0003 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Drug abuser	Social circumstances	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Substance use	Social circumstances	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Abortion induced	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Detoxification	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Liver transplant	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 affected9,620 at risk EG0011 affected90 at risk EG0020 affected518 at risk
Oophorectomy	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Angiodysplasia	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Circulatory collapse	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Femoral artery embolism	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Haemorrhage	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Hypertensive crisis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Venous thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG000471 affected9,620 at risk EG00137 affected90 at risk EG0020 affected518 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG000311 affected9,620 at risk EG00130 affected90 at risk EG0020 affected518 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG000299 affected9,620 at risk EG00131 affected90 at risk EG0020 affected518 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG000187 affected9,620 at risk EG0017 affected90 at risk EG0020 affected518 at risk
Cheilitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00010 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Gastritis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00028 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG000121 affected9,620 at risk EG0015 affected90 at risk EG0020 affected518 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG000820 affected9,620 at risk EG00116 affected90 at risk EG0020 affected518 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00071 affected9,620 at risk EG0015 affected90 at risk EG0020 affected518 at risk
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0003,380 affected9,620 at risk EG00149 affected90 at risk EG0020 affected518 at risk
Influenza like illness	General disorders	MedDRA (15.0)	Systematic Assessment	EG000433 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Irritability	General disorders	MedDRA (15.0)	Systematic Assessment	EG000637 affected9,620 at risk EG0010 affected90 at risk EG0020 affected518 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG000801 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Oral candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00054 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Weight decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG000890 affected9,620 at risk EG00122 affected90 at risk EG0020 affected518 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001,258 affected9,620 at risk EG0017 affected90 at risk EG0020 affected518 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG000873 affected9,620 at risk EG0019 affected90 at risk EG0020 affected518 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG000232 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001,348 affected9,620 at risk EG00115 affected90 at risk EG0020 affected518 at risk
Visual field defect	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected9,620 at risk EG0015 affected90 at risk EG0020 affected518 at risk
Depressed mood	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG000865 affected9,620 at risk EG00116 affected90 at risk EG0020 affected518 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG000705 affected9,620 at risk EG00118 affected90 at risk EG0020 affected518 at risk
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG000857 affected9,620 at risk EG0019 affected90 at risk EG0020 affected518 at risk
Sleep disorder	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG000234 affected9,620 at risk EG0017 affected90 at risk EG0020 affected518 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG000247 affected9,620 at risk EG00112 affected90 at risk EG0020 affected518 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG000555 affected9,620 at risk EG0016 affected90 at risk EG0020 affected518 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00062 affected9,620 at risk EG0017 affected90 at risk EG0020 affected518 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG000569 affected9,620 at risk EG00110 affected90 at risk EG0020 affected518 at risk
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001,316 affected9,620 at risk EG00119 affected90 at risk EG0020 affected518 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
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides