Prospective Observational Epidemiologic Study of Maraviro... | NCT00665561

ID	Type	Description	Link
2007-006148-24	EudraCT Number
POEM	Other Identifier	Alias Study Number

Name	Class
Pfizer	INDUSTRY

Label	Type	Description	Intervention Names
Maraviroc exposed			Drug: Maraviroc along with an optimized background antiretroviral drug regimen
Maraviroc unexposed			Drug: Optimized background antiretroviral drug regimen without maraviroc

Name	Type	Description	Arm Group Labels	Other Names
Maraviroc along with an optimized background antiretroviral drug regimen	Drug	Maraviroc prescribed per approved local label.	Maraviroc exposed

Measure	Description	Time Frame
Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections	Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).	Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis	Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.	Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)	Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.	Up to 5 years following enrollment
Density Rate Per 1000 Participant-Years for Incidence of Liver Failure	Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Health Services Center		Hobson City	Alabama	36201	United States
AAC/Davis Clinic

ID	Title	Description
FG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 29, 2010	Feb 12, 2020

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

Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections

Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Units	Counts
Participants	OG0001316 OG0011130

Title

Denominators

Categories

Title	Measurements
	OG00022.28(18.57 to 26.73) OG00141.77(36.09 to 48.34)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.					Risk Ratio (RR)	0.53			2-Sided	95	0.42	0.67					Superiority

Primary

Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis

Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)

Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of Liver Failure

Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'

Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed

Primary

Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'

Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis

Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause

Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause

Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections

Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)

Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed

Primary

Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'

Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001

Primary

Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'

Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause

Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

95% Confidence Interval

events per 1000 participant-years

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Primary

Percentage of Participants With All-Cause Mortality

All-cause death was defined as the death due to any cause during the course of study.

Safety analysis set included all participants who were enrolled in the study.

Posted

Number

Percentage of participants

Up to 5 years following enrollment

ID	Title	Description
OG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
OG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG00011 affected1,316 at risk EG00114 affected1,130 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Eosinophilia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0012 affected1,130 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Lymphocytosis	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Methaemoglobinaemia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0015 affected1,130 at risk
Sickle cell anaemia with crisis	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG0016 affected1,130 at risk
Angina pectoris	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Angina unstable	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Arrhythmia	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0016 affected1,130 at risk
Bradycardia	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cardiac arrest	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0012 affected1,130 at risk
Cardiac failure	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0011 affected1,130 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG00111 affected1,130 at risk
Cardiac valve disease	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0011 affected1,130 at risk
Cardiogenic shock	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Cardiomyopathy	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Coronary artery disease	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0006 affected1,316 at risk EG0014 affected1,130 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Left ventricular failure	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0013 affected1,130 at risk
Myocardial infarction	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG00016 affected1,316 at risk EG00112 affected1,130 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Myocarditis	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Palpitations	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pericarditis	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Tachycardia	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Torsade de pointes	Cardiac disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Fanconi syndrome	Congenital, familial and genetic disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Sickle cell disease	Congenital, familial and genetic disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Deafness bilateral	Ear and labyrinth disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Adrenal mass	Endocrine disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Autoimmune hypothyroidism	Endocrine disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hypothyroidism	Endocrine disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Cataract	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0010 affected1,130 at risk
Central vision loss	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Iridocyclitis	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Orbital cyst	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pupils unequal	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Uveitis	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Vision blurred	Eye disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0008 affected1,316 at risk EG00111 affected1,130 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anal fissure	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anal fistula	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Anal skin tags	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anogenital dysplasia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ascites	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Colitis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Constipation	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0012 affected1,130 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG00010 affected1,316 at risk EG00113 affected1,130 at risk
Diverticulum	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Duodenitis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gastritis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0013 affected1,130 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0011 affected1,130 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Haematemesis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Haematochezia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Ileus	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0012 affected1,130 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Intussusception	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Melaena	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Nausea	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0012 affected1,130 at risk
Odynophagia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oesophageal haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oral pain	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0006 affected1,316 at risk EG0012 affected1,130 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0016 affected1,130 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Proctalgia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Proctitis	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Proctitis ulcerative	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Rectal perforation	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vomiting	Gastrointestinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0014 affected1,130 at risk
Asthenia	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0015 affected1,130 at risk
Chest pain	General disorders	MedDRA v21.1	Non-systematic Assessment	EG00016 affected1,316 at risk EG00115 affected1,130 at risk
Chills	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Death	General disorders	MedDRA v21.1	Non-systematic Assessment	EG00010 affected1,316 at risk EG0016 affected1,130 at risk
Dysplasia	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Fatigue	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gait disturbance	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
General physical health deterioration	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Generalised oedema	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hypothermia	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Malaise	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Mucosal inflammation	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Multi-organ disorder	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Oedema peripheral	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pain	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Physical deconditioning	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pyrexia	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0008 affected1,316 at risk EG00111 affected1,130 at risk
Sudden cardiac death	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Sudden death	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Treatment noncompliance	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Ulcer	General disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Biliary dilatation	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0011 affected1,130 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0012 affected1,130 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0014 affected1,130 at risk
Hepatitis alcoholic	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Jaundice	Hepatobiliary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Drug hypersensitivity	Immune system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Hypersensitivity	Immune system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Jarisch-Herxheimer reaction	Immune system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
AIDS related complication	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
AIDS retinopathy	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abdominal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abdominal sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Abscess limb	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0014 affected1,130 at risk
Acquired immunodeficiency syndrome	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0016 affected1,130 at risk
Acute hepatitis C	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Acute sinusitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Amoebiasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Amoebic dysentery	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Anal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Anorectal cellulitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Appendicitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG0014 affected1,130 at risk
Arthritis bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Aspergillus infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Atypical mycobacterial infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Bacteraemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0015 affected1,130 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Bacterial infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Brain abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Breast abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Bronchiolitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Bronchitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG00010 affected1,316 at risk EG0016 affected1,130 at risk
Bronchitis viral	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Burkholderia cepacia complex sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
CNS ventriculitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Campylobacter gastroenteritis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Campylobacter infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Candida infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Cellulitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG00012 affected1,316 at risk EG00118 affected1,130 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cerebral toxoplasmosis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0013 affected1,130 at risk
Clostridium difficile infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0014 affected1,130 at risk
Corneal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cryptococcal fungaemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cryptococcosis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cryptosporidiosis infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cytomegalovirus chorioretinitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cytomegalovirus infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Cytomegalovirus viraemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Device related infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Device related sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Diabetic foot infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Diverticulitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Empyema	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Encephalitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
End stage AIDS	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Endocarditis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Enterococcal sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Epididymitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Erysipelas	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
External ear cellulitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Eye infection syphilitic	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Folliculitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Fungal infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Fungal oesophagitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Furuncle	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gangrene	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Gastroenteritis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG00111 affected1,130 at risk
Gastroenteritis bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gastroenteritis clostridial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastroenteritis cryptosporidial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Gastroenteritis viral	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Genital herpes	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Genital herpes simplex	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Giardiasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gonorrhoea	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
HIV enteropathy	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
HIV infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
HIV wasting syndrome	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
HIV-associated neurocognitive disorder	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Helicobacter gastritis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Helicobacter infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Hepatitis B reactivation	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hepatitis C	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Herpes pharyngitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Herpes simplex	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0014 affected1,130 at risk
Herpes virus infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Herpes zoster	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0014 affected1,130 at risk
Herpes zoster disseminated	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Histoplasmosis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Infectious colitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Influenza	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Intervertebral discitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Joint abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Klebsiella sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Latent syphilis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0013 affected1,130 at risk
Lung infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Meningitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Meningitis aseptic	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Meningitis cryptococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0014 affected1,130 at risk
Meningitis streptococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Meningitis tuberculous	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Microsporidia infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Mycobacterial infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Mycobacterium abscessus infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Mycobacterium avium complex infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0014 affected1,130 at risk
Mycobacterium fortuitum infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Neurosyphilis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Neutropenic sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0018 affected1,130 at risk
Oral candidiasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0013 affected1,130 at risk
Oral hairy leukoplakia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Oral herpes	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Orchitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Osteomyelitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Otitis externa	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Otitis media	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Parvovirus infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Perirectal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Peritonitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0010 affected1,130 at risk
Peritonitis bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Pharyngitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Pilonidal cyst	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pneumococcal sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0009 affected1,316 at risk EG00113 affected1,130 at risk
Pneumonia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG00051 affected1,316 at risk EG00154 affected1,130 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0014 affected1,130 at risk
Pneumonia influenzal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pneumonia legionella	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pneumonia necrotising	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Post procedural infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Postoperative wound infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Progressive multifocal leukoencephalopathy	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Pyelonephritis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0015 affected1,130 at risk
Pyelonephritis acute	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Rectal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Respiratory tract infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Salmonella sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Secondary syphilis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Sepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG00011 affected1,316 at risk EG00111 affected1,130 at risk
Sepsis syndrome	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Septic embolus	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Septic shock	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0013 affected1,130 at risk
Shigella infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Sinusitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0013 affected1,130 at risk
Sinusitis bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Sinusitis fungal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Staphylococcal abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0013 affected1,130 at risk
Staphylococcal infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0014 affected1,130 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Subcutaneous abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0014 affected1,130 at risk
Superinfection bacterial	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Syphilis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Syphilis anal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Tonsillitis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Tooth abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Toxoplasmosis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Trichomoniasis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Tuberculosis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Urinary tract infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG00010 affected1,316 at risk EG0018 affected1,130 at risk
Urinary tract infection pseudomonal	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Urosepsis	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Vaginal infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vascular device infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Viral infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vulval abscess	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Accident	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Breast injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0006 affected1,316 at risk EG0011 affected1,130 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Foreign body in gastrointestinal tract	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Foreign body in respiratory tract	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Fractured sacrum	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastrointestinal stoma necrosis	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG0013 affected1,130 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Radial nerve injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0010 affected1,130 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Splenic injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Traumatic liver injury	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Atypical mycobacterium test positive	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Biopsy lymph gland	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Blood potassium decreased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Body temperature increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Culture stool positive	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Drug clearance increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Electrocardiogram repolarisation abnormality	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
HIV test positive	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Haemophilus test positive	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Hepatic enzyme increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Liver function test abnormal	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Liver function test increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Staphylococcus test	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Staphylococcus test positive	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Transaminases increased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Weight decreased	Investigations	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Alcoholic ketoacidosis	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0017 affected1,130 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Electrolyte depletion	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0014 affected1,130 at risk
Folate deficiency	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gout	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Haemochromatosis	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0016 affected1,130 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0014 affected1,130 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0012 affected1,130 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Diastasis recti abdominis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0011 affected1,130 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0011 affected1,130 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Anal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anaplastic large cell lymphoma T- and null-cell types	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Anogenital warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0014 affected1,130 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Burkitt's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Cervix carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Diffuse large B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastrointestinal lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0006 affected1,316 at risk EG0011 affected1,130 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0013 affected1,130 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Malignant melanoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Neoplasm prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Ocular neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1 at risk EG0010 affected1,130 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Pancreatic carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Plasmablastic lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0013 affected1,130 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
T-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Vaginal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Alcoholic seizure	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Amputation stump pain	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Balance disorder	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cerebellar infarction	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Cerebral infarction	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG0014 affected1,130 at risk
Clonic convulsion	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cranial nerve palsies multiple	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Dementia	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Dizziness	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0015 affected1,130 at risk
Dysarthria	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Embolic stroke	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Encephalitis post varicella	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Encephalopathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Epilepsy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Facial paralysis	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Headache	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0015 affected1,130 at risk
Hemiparesis	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0015 affected1,130 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Intraventricular haemorrhage	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0010 affected1,130 at risk
Lacunar stroke	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Lethargy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Mental impairment	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Migraine	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Motor dysfunction	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Myoclonus	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Nervous system disorder	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Parkinson's disease	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Polyneuropathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Posterior reversible encephalopathy syndrome	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Radiculopathy	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Seizure	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0008 affected1,316 at risk EG0015 affected1,130 at risk
Somnolence	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Syncope	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0010 affected1,130 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Device dislocation	Product Issues	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Adjustment disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Affective disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Aggression	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Alcoholism	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Bipolar disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Borderline personality disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Completed suicide	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Confusional state	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Delirium	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Depression	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0016 affected1,130 at risk
Depression suicidal	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Drug abuse	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Homicidal ideation	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Major depression	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Mania	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Mental status changes	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0018 affected1,130 at risk
Organic brain syndrome	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Psychotic disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Schizophrenia	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Substance abuse	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0012 affected1,130 at risk
Substance-induced psychotic disorder	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Suicidal ideation	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Suicide attempt	Psychiatric disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0008 affected1,316 at risk EG00118 affected1,130 at risk
Calculus urinary	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0013 affected1,130 at risk
End stage renal disease	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Glomerulonephritis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0013 affected1,130 at risk
Nephropathy	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Proteinuria	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Renal colic	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Renal failure	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG00010 affected1,316 at risk EG0014 affected1,130 at risk
Renal haematoma	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Renal injury	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Renal vein thrombosis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Fallopian tube obstruction	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Ovarian vein thrombosis	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Painful erection	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pelvic adhesions	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Perineal rash	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Testicular swelling	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0013 affected1,130 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0005 affected1,316 at risk EG0014 affected1,130 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0017 affected1,130 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0006 affected1,316 at risk EG0012 affected1,130 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0013 affected1,130 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0014 affected1,130 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0014 affected1,130 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0007 affected1,316 at risk EG0016 affected1,130 at risk
Pulmonary eosinophilia	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0018 affected1,130 at risk
Stridor	Respiratory, thoracic and mediastinal disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Lipodystrophy acquired	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0010 affected1,130 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0012 affected1,130 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Abdominal hernia repair	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Abscess drainage	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Arterial stent insertion	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Cataract operation	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Colostomy	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Gastric banding reversal	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hip surgery	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hysterectomy	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Immune tolerance induction	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Leg amputation	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Medical device removal	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Renal transplant	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Valvuloplasty cardiac	Surgical and medical procedures	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Aortic aneurysm	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0011 affected1,130 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Bleeding varicose vein	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Circulatory collapse	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Deep vein thrombosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0013 affected1,130 at risk
Haematoma	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Hypertension	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0004 affected1,316 at risk EG0016 affected1,130 at risk
Hypertensive crisis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0012 affected1,130 at risk
Hypotension	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0017 affected1,130 at risk
Hypovolaemic shock	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Iliac artery occlusion	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Lymphoedema	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0013 affected1,130 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0003 affected1,316 at risk EG0012 affected1,130 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0011 affected1,130 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Subclavian artery thrombosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Thrombophlebitis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0002 affected1,316 at risk EG0010 affected1,130 at risk
Thrombosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Vascular stenosis	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0000 affected1,316 at risk EG0011 affected1,130 at risk
Vasospasm	Vascular disorders	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk
Infected neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v21.1	Non-systematic Assessment	EG0001 affected1,316 at risk EG0010 affected1,130 at risk

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012897	Slow Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
BG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Maraviroc Exposed	Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	75	1,316	435	1,316	111	1,316
EG001	Maraviroc Unexposed	HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.	79	1,130	352	1,130	34	1,130