Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-... | NCT00526474

Name	Class
The TIMI Study Group	OTHER

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.	Drug: Placebo
Vorapaxar	Experimental	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.	Drug: Vorapaxar

Name	Type	Description	Arm Group Labels	Other Names
Vorapaxar	Drug	2.5-mg tablet daily for at least 1 year	Vorapaxar
Placebo

Measure	Description	Time Frame
Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization	The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.	up to 3 years

Measure	Description	Time Frame
Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization	The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
35224730	Derived	Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
33884889	Derived	Berg DD, Freedman BL, Bonaca MP, Jarolim P, Scirica BM, Goodrich EL, Sabatine MS, Morrow DA. Cardiovascular Biomarkers and Heart Failure Risk in Stable Patients With Atherothrombotic Disease: A Nested Biomarker Study From TRA 2 degrees P-TIMI 50. J Am Heart Assoc. 2021 May 4;10(9):e018673. doi: 10.1161/JAHA.120.018673. Epub 2021 Apr 22.

ID	Type	URL	Comment
	CSR Synopsis	View IPD

ID	Title	Description
FG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
FG001	Vorapaxar

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

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, or Urgent Coronary Revascularization (UCR) Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.

Intent to Treat (ITT) Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Units	Counts
Participants	OG00013224 OG00113225

Title

Denominators

Categories

Title	Measurements
	OG00012.4 OG00111.2

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		Cox Proportional Hazards Regression	Hazard Ratio calculated with covariates for treatment and stratification factors	0.001		Cox Proportional Hazard	0.88			2-Sided	95	0.82	0.95			Hazard ratio calculated by dividing the Kaplan-Meier (KM) Estimate for vorapaxar by the KM Estimate for Placebo and correcting for covariates. A hazard ratio <1 would indicate a lower hazard associated with vorapaxar relative to placebo.		Superiority or Other

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, or stroke. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, or stroke within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Met Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries (GUSTO) Moderate or Severe Bleeding Criteria Within 3 Years From Randomization

Adverse events were categorized as "bleeding events" if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the GUSTO cooperative group criteria as follows: Mild , Moderate or Severe and the grading was adjudicated by the CEC. The Kaplan-Meier estimate reports the percentage of participants who experienced GUSTO moderate or severe bleeding within 3 years from randomization.

As Treated Population, which included all participants who received at least 1 dose of study medication.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization

Adverse events were categorized as "bleeding events" if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria as major, minor or other. "Clinically Significant Bleeding" was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.

As Treated Population, which included all participants who received at least 1 dose of study medication.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization

The time (in days) from study start to the occurrence of any of the following clinical outcomes was recorded: death from any cause, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, MI, stroke, or UCR within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Perentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization

The time (in days) from study start to the occurrence of CV death or MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or Urgent Hospitalization for Vascular Cause of Ischemic Nature (UH-VCIN) Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization

The time (in days) from study start to death from any cause or the first occurrence of any of the following clinical outcomes was recorded: MI, stroke, or any revascularization procedure . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause, or experienced an MI, stroke, or any revascularization within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, any revascularization, or UH-VCIN. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, any revascularization procedure, or UH-VCIN within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization

The time (in days) from study start to CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of an MI was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced an MI within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of UCR was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced UCR within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization

The time (in days) from study start to first experience of a stroke was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced a stroke within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization

The time (in days) from study start to death from any cause was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who died from any cause within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Units

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of an UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Secondary

Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of a revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.

ITT Population, defined as all participants who were randomly assigned to a treatment arm.

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, or UCR Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, or UCR. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, or UCR within 3 years from randomization.

Intended Label Population: all enrolled participants with coronary arterial disease (CAD) or peripheral arterial disease (PAD) and no history of a stroke or transient ischemic attack (TIA)

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, or Stroke Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Met GUSTO Moderate or Severe Bleeding Criteria Within 3 Years From Randomization

Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Clinically Significant Bleeding Within 3 Years From Randomization

Adverse events were categorized as "bleeding events" if the intensity, frequency, or type of the event was other or more than would be normally expected in the given situation (eg, mild nosebleed in a person who does not normally have nosebleeds, greater bruising than expected for a given injury, greater volume of blood loss than expected for a given procedure). The investigator graded the intensity of bleeding events according to the TIMI Study Group criteria as major, minor or other. "Clinically Significant Bleeding" was defined as the composite of TIMI Major bleeding, TIMI Minor bleeding, or bleeding that required unplanned medical or surgical treatment or unplanned laboratory evaluation even if it did not meet the criteria for TIMI major or minor bleeding. The Kaplan-Meier estimate reports the percentage of participants who experienced clinically significant bleeding within 3 years from randomization.

Intended Label Safety Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA who received at least 1 dose of study drug

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced Death From Any Cause, MI, Stroke, or UCR Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death or an MI Within 3 Years From Randomization

The time (in days) from study start to the occurrence of CV death or first occurrence of an MI. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death or MI within 3 years from randomization.

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Partcipants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, UCR, or UH-VCIN Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, MI, stroke, UCR, or UH-VCIN . A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, MI, stroke, UCR, or UH-VCIN within 3 years from randomization.

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause, or Experienced an MI, Stroke, or Any Revascularization Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death, MI, Stroke, Any Revascularization, or UH-VCIN Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced CV Death Within 3 Years From Randomization

The time (in days) from study start to the CV death (if reported) was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who experienced CV death within 3 years from randomization.

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced an MI Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced UCR Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Experienced a Stroke Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Died From Any Cause Within 3 Years From Randomization

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Had a UH-VCIN Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of a UH-VCIN was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had a UH-VCIN within 3 years from randomization.

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Post-Hoc

Kaplan-Meier Estimate of the Percentage of Participants Who Had Any Revascularization Performed Within 3 Years From Randomization

The time (in days) from study start to the first occurrence of any revascularization was recorded. A CEC reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or participants who were lost to follow-up and had no event were censored at the time of last available information (last study visit). If a participant had a fatal event that was not part of a specific endpoint for analysis, they were censored at the time of death. The Kaplan-Meier estimate reports the percentage of participants who had any revascularization performed within 3 years from randomization.

Intended Label Population: all enrolled participants with CAD or PAD and no history of a stroke or TIA

Posted

Number

Percentage of Participants

up to 3 years

ID	Title	Description
OG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
OG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00013 events12 affected13,166 at risk EG00147 events45 affected13,186 at risk
ANAEMIA HAEMOLYTIC AUTOIMMUNE	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANAEMIA OF CHRONIC DISEASE	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
APLASIA PURE RED CELL	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
AUTOIMMUNE THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMORRHAGIC DIATHESIS	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0017 events7 affected13,186 at risk
HEPARIN-INDUCED THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
IDIOPATHIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG00116 events16 affected13,186 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
LEUKOPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
NEPHROGENIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
NORMOCHROMIC NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PANCYTOPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
PERNICIOUS ANAEMIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RETROPERITONEAL LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SPLENIC HAEMORRHAGE	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG00023 events23 affected13,166 at risk EG00120 events19 affected13,186 at risk
THROMBOCYTOSIS	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
THROMBOTIC THROMBOCYTOPENIC PURPURA	Blood and lymphatic system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ADAMS-STOKES SYNDROME	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected13,166 at risk EG0012 events2 affected13,186 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0015 events5 affected13,186 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
ARRHYTHMIA SUPRAVENTRICULAR	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000118 events106 affected13,166 at risk EG001156 events137 affected13,186 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00019 events18 affected13,166 at risk EG00128 events28 affected13,186 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected13,166 at risk EG00119 events19 affected13,186 at risk
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected13,166 at risk EG0014 events4 affected13,186 at risk
BIFASCICULAR BLOCK	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00027 events27 affected13,166 at risk EG00120 events20 affected13,186 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
CARDIAC ANEURYSM	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected13,166 at risk EG0012 events2 affected13,186 at risk
CARDIAC ASTHMA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG000222 events174 affected13,166 at risk EG001245 events183 affected13,186 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0015 events4 affected13,186 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00099 events82 affected13,166 at risk EG001121 events95 affected13,186 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0015 events4 affected13,186 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG0018 events8 affected13,186 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CHRONOTROPIC INCOMPETENCE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events2 affected13,186 at risk
EXTRASYSTOLES	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEART VALVE INCOMPETENCE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG00111 events11 affected13,186 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG00110 events10 affected13,186 at risk
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
MITRAL VALVE PROLAPSE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MITRAL VALVE STENOSIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
MYOCARDIAL RUPTURE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
MYOPERICARDITIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NODAL ARRHYTHMIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
PALPITATIONS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0017 events7 affected13,186 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
PERICARDIAL HAEMORRHAGE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0018 events8 affected13,186 at risk
PERICARDITIS	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0013 events3 affected13,186 at risk
PULSELESS ELECTRICAL ACTIVITY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected13,166 at risk EG00122 events20 affected13,186 at risk
SINUS ARREST	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
STRESS CARDIOMYOPATHY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00020 events16 affected13,166 at risk EG00114 events13 affected13,186 at risk
TACHYARRHYTHMIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
VENTRICULAR ASYSTOLE	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VENTRICULAR DYSSYNCHRONY	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00016 events15 affected13,166 at risk EG00116 events16 affected13,186 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 14.1	Systematic Assessment	EG00049 events37 affected13,166 at risk EG00142 events37 affected13,186 at risk
ARTERIOVENOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ATRIAL SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
EPIDERMOLYSIS	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROINTESTINAL ANGIODYSPLASIA	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HAEMORRHAGIC ARTERIOVENOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HIP DYSPLASIA	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYDROCELE	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
PHIMOSIS	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PORPHYRIA	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PYLORIC STENOSIS	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VENTRICULAR SEPTAL DEFECT	Congenital, familial and genetic disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACUTE VESTIBULAR SYNDROME	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DEAFNESS	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPOACUSIS	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MENIERE'S DISEASE	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
SUDDEN HEARING LOSS	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG00017 events16 affected13,166 at risk EG00124 events23 affected13,186 at risk
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
VESTIBULAR DISORDER	Ear and labyrinth disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
ADDISON'S DISEASE	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ADRENAL MASS	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
AUTOIMMUNE THYROIDITIS	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
BASEDOW'S DISEASE	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
GOITRE	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPERCALCAEMIA OF MALIGNANCY	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPERPARATHYROIDISM	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events4 affected13,186 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	Endocrine disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
AMAUROSIS	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLINDNESS UNILATERAL	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CATARACT	Eye disorders	MedDRA 14.1	Systematic Assessment	EG00015 events15 affected13,166 at risk EG00112 events10 affected13,186 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CORNEAL OEDEMA	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIABETIC RETINOPATHY	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events2 affected13,186 at risk
ENDOCRINE OPHTHALMOPATHY	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EYE HAEMORRHAGE	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
GLAUCOMA	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPHAEMA	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LACRIMATION INCREASED	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MACULAR DEGENERATION	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MACULAR FIBROSIS	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MACULAR HOLE	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OCULAR HYPERTENSION	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OPTIC ISCHAEMIC NEUROPATHY	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OPTIC NEUROPATHY	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTERIOR CAPSULE OPACIFICATION	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RETINAL ARTERY THROMBOSIS	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
RETINAL VEIN OCCLUSION	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RETINAL VEIN THROMBOSIS	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ULCERATIVE KERATITIS	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VISION BLURRED	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VISUAL IMPAIRMENT	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VITREOUS HAEMORRHAGE	Eye disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ABDOMINAL ADHESIONS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ABDOMINAL COMPARTMENT SYNDROME	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
ABDOMINAL HERNIA OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL MASS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00018 events17 affected13,166 at risk EG0019 events9 affected13,186 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00110 events10 affected13,186 at risk
ABDOMINAL WALL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACUTE ABDOMEN	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ANAL FISTULA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
ANAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ASCITES	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
BARRETT'S OESOPHAGUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
BUCCAL POLYP	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COLITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0019 events9 affected13,186 at risk
COLITIS EROSIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0019 events8 affected13,186 at risk
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG00114 events14 affected13,186 at risk
COLONIC PSEUDO-OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG00111 events11 affected13,186 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DENTAL NECROSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIABETIC GASTROPARESIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0018 events7 affected13,186 at risk
DIARRHOEA HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
DIVERTICULAR PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIVERTICULITIS INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events4 affected13,186 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0015 events3 affected13,186 at risk
DIVERTICULUM OESOPHAGEAL	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DUODENAL PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0019 events8 affected13,186 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
DUODENITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG00110 events10 affected13,186 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0014 events4 affected13,186 at risk
ENTERITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
ENTEROCELE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ENTEROCOLITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENTEROCOLITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ENTEROVESICAL FISTULA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EPIGASTRIC DISCOMFORT	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EPIPLOIC APPENDAGITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
EROSIVE DUODENITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
EROSIVE OESOPHAGITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events4 affected13,186 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
FAECES DISCOLOURED	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
FEMORAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
FUNCTIONAL GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRIC DISORDER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
GASTRIC PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG00111 events11 affected13,186 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0016 events6 affected13,186 at risk
GASTRIC ULCER PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTRIC VOLVULUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00029 events29 affected13,166 at risk EG00126 events26 affected13,186 at risk
GASTRITIS ALCOHOLIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTRITIS ATROPHIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0017 events6 affected13,186 at risk
GASTRODUODENAL ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00042 events38 affected13,166 at risk EG00170 events62 affected13,186 at risk
GASTROINTESTINAL INFLAMMATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROINTESTINAL NECROSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
GASTROINTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL TELANGIECTASIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
GASTROINTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00033 events31 affected13,166 at risk EG00124 events23 affected13,186 at risk
GINGIVAL BLEEDING	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00019 events19 affected13,166 at risk EG00128 events28 affected13,186 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00024 events21 affected13,166 at risk EG00118 events16 affected13,186 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected13,166 at risk EG0017 events7 affected13,186 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events4 affected13,186 at risk
HERNIAL EVENTRATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0014 events4 affected13,186 at risk
ILEAL STENOSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ILEUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG00110 events8 affected13,186 at risk
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
INFLAMMATORY BOWEL DISEASE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00035 events35 affected13,166 at risk EG00144 events42 affected13,186 at risk
INGUINAL HERNIA STRANGULATED	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INGUINAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0013 events3 affected13,186 at risk
INTESTINAL MASS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00114 events13 affected13,186 at risk
INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0017 events7 affected13,186 at risk
INTESTINAL POLYP	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
INTESTINAL STRANGULATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
JEJUNAL PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LARGE INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LARGE INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LARGE INTESTINAL ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARGE INTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0015 events5 affected13,186 at risk
LUMBAR HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MALABSORPTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
MECHANICAL ILEUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
MELAENA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00049 events44 affected13,166 at risk EG00176 events69 affected13,186 at risk
MESENTERIC ARTERY STENOSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MESENTERIC ARTERY THROMBOSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MESENTERIC VASCULAR INSUFFICIENCY	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MOUTH CYST	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0018 events8 affected13,186 at risk
OESOPHAGEAL ACHALASIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OESOPHAGEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OESOPHAGEAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OESOPHAGEAL RUPTURE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
OESOPHAGEAL SPASM	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
OESOPHAGEAL STENOSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OESOPHAGEAL ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
OESOPHAGEAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG00111 events10 affected13,186 at risk
PANCREATIC CYST	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PANCREATIC DISORDER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00021 events17 affected13,166 at risk EG00118 events17 affected13,186 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00013 events11 affected13,166 at risk EG00111 events9 affected13,186 at risk
PANCREATITIS RELAPSING	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PAPILLA OF VATER STENOSIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PAROTID GLAND ENLARGEMENT	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0015 events5 affected13,186 at risk
PEPTIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PHARYNGOESOPHAGEAL DIVERTICULUM	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYP COLORECTAL	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROCTITIS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROCTITIS HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PROCTITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00041 events37 affected13,166 at risk EG00159 events53 affected13,186 at risk
RECTAL PROLAPSE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RECTAL ULCER	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RETROPERITONEAL HAEMATOMA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0018 events8 affected13,186 at risk
SALIVARY GLAND CALCULUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SMALL INTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00018 events14 affected13,166 at risk EG00112 events12 affected13,186 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SPIGELIAN HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SPLENIC ARTERY ANEURYSM	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SUBILEUS	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
THROMBOSIS MESENTERIC VESSEL	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TONGUE HAEMATOMA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TONGUE OEDEMA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG0016 events6 affected13,186 at risk
UMBILICAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG00020 events17 affected13,166 at risk EG00116 events15 affected13,186 at risk
VARICES OESOPHAGEAL	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VOMITING	Gastrointestinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0011 events1 affected13,186 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected13,166 at risk EG00116 events16 affected13,186 at risk
APPLICATION SITE BLEEDING	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ASTHENIA	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0011 events1 affected13,186 at risk
CATHETER SITE HAEMATOMA	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0018 events8 affected13,186 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0015 events5 affected13,186 at risk
CHEST DISCOMFORT	General disorders	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected13,166 at risk EG0016 events6 affected13,186 at risk
CHEST PAIN	General disorders	MedDRA 14.1	Systematic Assessment	EG00016 events14 affected13,166 at risk EG00115 events15 affected13,186 at risk
CYST	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CYST RUPTURE	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DEVICE BREAKAGE	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DEVICE DISLOCATION	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected13,166 at risk EG0014 events3 affected13,186 at risk
DEVICE FAILURE	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
DEVICE LEAD DAMAGE	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
DEVICE MALFUNCTION	General disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0017 events7 affected13,186 at risk
DEVICE OCCLUSION	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DISCOMFORT	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
DRUG INTERACTION	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EXERCISE TOLERANCE DECREASED	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
FATIGUE	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
GAIT DISTURBANCE	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
GENERAL PHYSICAL HEALTH DETERIORATION	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
GRAVITATIONAL OEDEMA	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HERNIA	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events2 affected13,186 at risk
HERNIA OBSTRUCTIVE	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
HYPERPLASIA	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPERTROPHY	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPOTHERMIA	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ILL-DEFINED DISORDER	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
IMPAIRED HEALING	General disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0016 events6 affected13,186 at risk
IMPLANT SITE EROSION	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
IMPLANT SITE PAIN	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INFLAMMATION	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
MALAISE	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0010 events0 affected13,186 at risk
MEDICAL DEVICE COMPLICATION	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
MUCOSAL INFLAMMATION	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MULTI-ORGAN DISORDER	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0016 events6 affected13,186 at risk
NECROSIS	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NODULE	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 14.1	Systematic Assessment	EG000548 events458 affected13,166 at risk EG001519 events443 affected13,186 at risk
OEDEMA	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
PAIN	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERFORATED ULCER	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYP	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
POLYSEROSITIS	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PYREXIA	General disorders	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected13,166 at risk EG0019 events9 affected13,186 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
THROMBOSIS IN DEVICE	General disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ULCER	General disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ULCER HAEMORRHAGE	General disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
BILE DUCT OBSTRUCTION	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
BILIARY DILATATION	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BILIARY DYSKINESIA	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
CHOLANGITIS ACUTE	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG00026 events26 affected13,166 at risk EG00132 events31 affected13,186 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG00019 events18 affected13,166 at risk EG00118 events18 affected13,186 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG00042 events42 affected13,166 at risk EG00143 events42 affected13,186 at risk
CHOLESTASIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
GALLBLADDER DISORDER	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GALLBLADDER POLYP	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
HEPATIC MASS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATITIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATITIS ACUTE	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATITIS TOXIC	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEPATORENAL SYNDROME	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATOTOXICITY	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ISCHAEMIC HEPATITIS	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
LIVER DISORDER	Hepatobiliary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ALLERGY TO ARTHROPOD STING	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ANAPHYLACTIC SHOCK	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG0014 events4 affected13,186 at risk
FOOD ALLERGY	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOGAMMAGLOBULINAEMIA	Immune system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ABSCESS INTESTINAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ABSCESS LIMB	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0017 events7 affected13,186 at risk
ABSCESS ORAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected13,166 at risk EG0017 events6 affected13,186 at risk
APPENDICEAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
APPENDICITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00023 events23 affected13,166 at risk EG00120 events20 affected13,186 at risk
ARTERIOVENOUS FISTULA SITE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTERIOVENOUS GRAFT SITE ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ARTERIOVENOUS GRAFT SITE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ASPERGILLOMA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BACTERAEMIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
BACTERIAL PROSTATITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BILIARY SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLASTOCYSTIS INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BORRELIA INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRONCHIOLITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRONCHITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00029 events29 affected13,166 at risk EG00127 events27 affected13,186 at risk
BRONCHITIS BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG00112 events12 affected13,186 at risk
BURSITIS INFECTIVE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
CAMPYLOBACTER GASTROENTERITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
CAMPYLOBACTER INTESTINAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CARDIAC INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CELLULITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00041 events38 affected13,166 at risk EG00145 events42 affected13,186 at risk
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CENTRAL NERVOUS SYSTEM INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
CHRONIC SINUSITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
CLOSTRIDIAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CLOSTRIDIUM COLITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00018 events16 affected13,166 at risk EG0014 events4 affected13,186 at risk
COCCIDIOIDOMYCOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CYSTITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0017 events7 affected13,186 at risk
CYTOMEGALOVIRUS INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DENGUE FEVER	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events7 affected13,166 at risk EG0015 events5 affected13,186 at risk
DEVICE RELATED SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
DIABETIC GANGRENE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DISSEMINATED TUBERCULOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00021 events20 affected13,166 at risk EG00117 events16 affected13,186 at risk
DYSENTERY	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EAR INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ECZEMA INFECTED	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EMPYEMA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENCEPHALITIS HERPES	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ENDOPHTHALMITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENTERITIS INFECTIOUS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENTEROBACTER INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENTEROCOLITIS INFECTIOUS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EPIDEMIC NEPHROPATHY	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EPIGLOTTITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ERYSIPELAS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00019 events18 affected13,166 at risk EG00115 events14 affected13,186 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ESCHERICHIA INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EYE ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FUNGAEMIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GANGRENE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRIC INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00039 events37 affected13,166 at risk EG00137 events36 affected13,186 at risk
GASTROENTERITIS ESCHERICHIA COLI	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROENTERITIS NOROVIRUS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
GASTROINTESTINAL BACTERIAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTROINTESTINAL VIRAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GINGIVAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GRAFT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0015 events5 affected13,186 at risk
GROIN ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0014 events4 affected13,186 at risk
GROIN INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
H1N1 INFLUENZA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
HAEMATOMA INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HELICOBACTER INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATITIS B	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEPATITIS C	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
HERPES SIMPLEX	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
HISTOPLASMOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HIV INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
IMPLANT SITE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INCISION SITE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INFECTED BITES	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INFECTED DERMAL CYST	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0019 events9 affected13,186 at risk
INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0017 events7 affected13,186 at risk
INFECTIOUS PERITONITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
INFECTIOUS PLEURAL EFFUSION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0010 events0 affected13,186 at risk
INFLUENZA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0011 events1 affected13,186 at risk
INFUSION SITE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LABYRINTHITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
LIVER ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected13,166 at risk EG00123 events23 affected13,186 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0018 events6 affected13,186 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected13,166 at risk EG0016 events6 affected13,186 at risk
LOWER RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LUNG INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0013 events3 affected13,186 at risk
LYME DISEASE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LYMPHANGITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MASTOIDITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MEDIASTINITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
MENINGITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MENINGITIS ASEPTIC	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MENINGITIS BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MENINGITIS VIRAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MYCOBACTERIUM AVIUM COMPLEX INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NECROTISING FASCIITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
OESOPHAGEAL CANDIDIASIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
ONYCHOMYCOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ORAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ORCHITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events4 affected13,186 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00019 events17 affected13,166 at risk EG00116 events14 affected13,186 at risk
OSTEOMYELITIS CHRONIC	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OTITIS MEDIA CHRONIC	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PAROTITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PERICARDITIS INFECTIVE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
PERIDIVERTICULAR ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERINEAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERINEPHRIC ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERIORBITAL CELLULITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERIRECTAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
PHARYNGITIS BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PILONIDAL CYST	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PNEUMOCYSTIS JIROVECI PNEUMONIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PNEUMONIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG000205 events186 affected13,166 at risk EG001185 events167 affected13,186 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
PNEUMONIA ESCHERICHIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PNEUMONIA FUNGAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PNEUMONIA MYCOPLASMAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PNEUMONIA PNEUMOCOCCAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
PNEUMONIA VIRAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
POST PROCEDURAL CELLULITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
POST PROCEDURAL SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTOPERATIVE ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00024 events21 affected13,166 at risk EG00110 events10 affected13,186 at risk
PSEUDOMEMBRANOUS COLITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PSOAS ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PULMONARY SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00013 events12 affected13,166 at risk EG00118 events18 affected13,186 at risk
PULMONARY TUBERCULOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected13,166 at risk EG00110 events10 affected13,186 at risk
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
RECTAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events8 affected13,166 at risk EG0016 events6 affected13,186 at risk
RESPIRATORY TRACT INFECTION VIRAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SALMONELLA SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SALMONELLOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SCROTAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00034 events34 affected13,166 at risk EG00129 events28 affected13,186 at risk
SEPTIC NECROSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00022 events22 affected13,166 at risk EG00113 events13 affected13,186 at risk
SERRATIA INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SIALOADENITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SINUSITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
SINUSITIS BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SKIN INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
SOFT TISSUE INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
STAPHYLOCOCCAL ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0014 events4 affected13,186 at risk
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
SUPERINFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SYPHILIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SYSTEMIC CANDIDA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TONSILLITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
TUBERCULOSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TYPHUS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0014 events4 affected13,186 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00053 events50 affected13,166 at risk EG00167 events62 affected13,186 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
URINARY TRACT INFECTION PSEUDOMONAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
URINARY TRACT INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
UROSEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG00127 events27 affected13,186 at risk
VAGINAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
VARICELLA	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VESTIBULAR NEURONITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG00111 events11 affected13,186 at risk
VIRAL LABYRINTHITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
VIRAL MYOCARDITIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WOUND ABSCESS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
WOUND INFECTION	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG00111 events11 affected13,186 at risk
WOUND INFECTION PSEUDOMONAS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WOUND SEPSIS	Infections and infestations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACCIDENT	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACETABULUM FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0018 events8 affected13,186 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
ANASTOMOTIC COMPLICATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANASTOMOTIC STENOSIS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00016 events15 affected13,166 at risk EG00118 events17 affected13,186 at risk
ARTERIAL INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BRAIN CONTUSION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BURNS THIRD DEGREE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CARBON MONOXIDE POISONING	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CARTILAGE INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
CHEMICAL EYE INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHEST INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected13,166 at risk EG0014 events4 affected13,186 at risk
CONFUSION POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00014 events11 affected13,166 at risk EG0017 events7 affected13,186 at risk
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
CYSTITIS RADIATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EAR INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ELECTRIC SHOCK	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EXCORIATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EXTRADURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FACE INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG0011 events1 affected13,186 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG00111 events11 affected13,186 at risk
FEBRILE NONHAEMOLYTIC TRANSFUSION REACTION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00023 events22 affected13,166 at risk EG00116 events16 affected13,186 at risk
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
FLAIL CHEST	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
FOREARM FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
FOREIGN BODY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL STOMA COMPLICATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
GUN SHOT WOUND	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0014 events4 affected13,186 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0018 events8 affected13,186 at risk
HEAT EXHAUSTION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEAT STROKE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00019 events19 affected13,166 at risk EG00116 events16 affected13,186 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00110 events9 affected13,186 at risk
INCISION SITE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
INCISION SITE PAIN	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0017 events7 affected13,186 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
INTERVERTEBRAL DISC INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
JAW FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00010 events9 affected13,166 at risk EG0019 events9 affected13,186 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00011 events10 affected13,166 at risk EG0016 events6 affected13,186 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0015 events5 affected13,186 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0016 events6 affected13,186 at risk
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MENISCUS LESION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0014 events4 affected13,186 at risk
MULTIPLE DRUG OVERDOSE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0017 events6 affected13,186 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NERVE INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OPEN FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OPEN WOUND	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OPERATIVE HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00020 events19 affected13,166 at risk EG00123 events23 affected13,186 at risk
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0017 events7 affected13,186 at risk
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
PERIPROSTHETIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POISONING	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
POST PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
POST PROCEDURAL DISCHARGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0012 events2 affected13,186 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00024 events23 affected13,166 at risk EG00140 events39 affected13,186 at risk
POSTOPERATIVE ADHESION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
POSTOPERATIVE FEVER	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTOPERATIVE ILEUS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0016 events5 affected13,186 at risk
POSTOPERATIVE RESPIRATORY DISTRESS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
POSTPERICARDIOTOMY SYNDROME	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
PUBIS FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
RADIATION ASSOCIATED PAIN	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RADIATION INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RADIATION OESOPHAGITIS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG00112 events12 affected13,186 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected13,166 at risk EG00113 events13 affected13,186 at risk
SCAPULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SKIN FLAP NECROSIS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SNAKE BITE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SPINAL COLUMN INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0016 events5 affected13,186 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0012 events2 affected13,186 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
STAB WOUND	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
STRUCK BY LIGHTNING	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected13,166 at risk EG00114 events14 affected13,186 at risk
SUBDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG00111 events11 affected13,186 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0016 events6 affected13,186 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
TRANSFUSION-RELATED ACUTE LUNG INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRAUMATIC ARTHRITIS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRAUMATIC HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
TRAUMATIC INTRACRANIAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRAUMATIC LIVER INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0015 events5 affected13,186 at risk
VACCINATION COMPLICATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VASCULAR INJURY	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0015 events5 affected13,186 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0014 events4 affected13,186 at risk
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0010 events0 affected13,186 at risk
WOUND EVISCERATION	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WOUND HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
WOUND NECROSIS	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events4 affected13,186 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
BLOOD GLUCOSE DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLOOD TRIGLYCERIDES INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CARDIAC STRESS TEST ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CLOSTRIDIUM TEST POSITIVE	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EJECTION FRACTION	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EJECTION FRACTION ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
EXERCISE ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EXERCISE TEST ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMATOCRIT DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
HEPATIC ENZYME ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HIV TEST POSITIVE	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INTERNATIONAL NORMALISED RATIO INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
OCCULT BLOOD	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OCCULT BLOOD POSITIVE	Investigations	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
PLATELET COUNT ABNORMAL	Investigations	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
PLATELET COUNT DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0014 events4 affected13,186 at risk
PRECANCEROUS CELLS PRESENT	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROTEIN URINE PRESENT	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY FUNCTION TEST DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RED BLOOD CELL COUNT DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RED BLOOD CELLS URINE POSITIVE	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WEIGHT DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
WHITE BLOOD CELL COUNT DECREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00034 events33 affected13,166 at risk EG00128 events28 affected13,186 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected13,166 at risk EG00123 events22 affected13,186 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00013 events12 affected13,166 at risk EG00117 events16 affected13,186 at risk
DIABETIC COMPLICATION	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
DIABETIC FOOT	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events3 affected13,186 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected13,166 at risk EG00110 events9 affected13,186 at risk
ELECTROLYTE IMBALANCE	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0014 events4 affected13,186 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events3 affected13,186 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG00111 events10 affected13,186 at risk
HAEMOSIDEROSIS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00019 events19 affected13,166 at risk EG00119 events18 affected13,186 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG0017 events7 affected13,186 at risk
HYPERVOLAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG00018 events17 affected13,166 at risk EG00126 events23 affected13,186 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0016 events6 affected13,186 at risk
HYPOPHAGIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
IRON METABOLISM DISORDER	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
TYPE 1 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0017 events7 affected13,186 at risk
VITAMIN B12 DEFICIENCY	Metabolism and nutrition disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0017 events7 affected13,186 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00023 events20 affected13,166 at risk EG00116 events16 affected13,186 at risk
ARTHROFIBROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00018 events16 affected13,166 at risk EG00111 events11 affected13,186 at risk
BONE CYST	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BONE FISTULA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0012 events2 affected13,186 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
CHONDROMALACIA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COMPARTMENT SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0014 events4 affected13,186 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0012 events2 affected13,186 at risk
DUPUYTREN'S CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
EXOSTOSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
FIBROMYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
FRACTURE NONUNION	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
GOUTY ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HAEMARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected13,166 at risk EG0018 events8 affected13,186 at risk
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00031 events31 affected13,166 at risk EG00119 events19 affected13,186 at risk
LIGAMENT LAXITY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected13,166 at risk EG0017 events7 affected13,186 at risk
MENISCAL DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MONARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MUSCLE ATROPHY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MUSCLE HAEMORRHAGE	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00029 events27 affected13,166 at risk EG00144 events41 affected13,186 at risk
MUSCULOSKELETAL DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00017 events17 affected13,166 at risk EG00115 events15 affected13,186 at risk
MUSCULOSKELETAL STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events5 affected13,166 at risk EG0012 events2 affected13,186 at risk
MYOFASCIAL PAIN SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEUROPATHIC ARTHROPATHY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OSTEITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00089 events84 affected13,166 at risk EG00176 events71 affected13,186 at risk
OSTEOCHONDROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
OSTEOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0015 events5 affected13,186 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PERIARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
POLYARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PSEUDARTHROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0012 events2 affected13,186 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00114 events14 affected13,186 at risk
SCOLIOSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SPINAL COLUMN STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00021 events21 affected13,166 at risk EG00114 events14 affected13,186 at risk
SPINAL DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected13,166 at risk EG0018 events8 affected13,186 at risk
SPONDYLITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
SYMPATHETIC POSTERIOR CERVICAL SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SYNOVIAL CYST	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TENDON DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
TENDON NECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TENOSYNOVITIS	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRIGGER FINGER	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VERTEBRAL WEDGING	Musculoskeletal and connective tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACUTE LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACUTE LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
ADENOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ADRENAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ADRENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ANAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ANOGENITAL WARTS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ASTROCYTOMA MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ATYPICAL FIBROXANTHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00020 events14 affected13,166 at risk EG00115 events14 affected13,186 at risk
BENIGN CARDIAC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BENIGN LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
BENIGN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
BENIGN NEOPLASM OF BLADDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
BENIGN NEOPLASM OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BENIGN NEOPLASM OF TESTIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BENIGN NEOPLASM OF THYROID GLAND	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
BENIGN RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BENIGN SALIVARY GLAND NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0015 events5 affected13,186 at risk
BILIARY CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
BILIARY NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00021 events21 affected13,166 at risk EG00125 events25 affected13,186 at risk
BLADDER CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0016 events5 affected13,186 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
BLADDER PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
BONE NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00019 events19 affected13,166 at risk EG00117 events17 affected13,186 at risk
BREAST CANCER IN SITU	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BREAST CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
BREAST CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BREAST NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0014 events4 affected13,186 at risk
BRONCHIOLOALVEOLAR CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CARCINOID TUMOUR OF THE DUODENUM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CARCINOMA IN SITU	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CERVIX CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHLOROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CHOLESTEATOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CHONDROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHONDROSARCOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHOROID MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0017 events7 affected13,186 at risk
CHRONIC MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0011 events1 affected13,186 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00025 events25 affected13,166 at risk EG00127 events27 affected13,186 at risk
COLON CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0019 events9 affected13,186 at risk
COLON CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COLON NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
COLORECTAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CONNECTIVE TISSUE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENDOMETRIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ESSENTIAL THROMBOCYTHAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
FIBROUS HISTIOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTRIC ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG0016 events6 affected13,186 at risk
GASTRIC CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTRIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GASTROINTESTINAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
GASTROINTESTINAL TRACT ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
GLIOBLASTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
GLIOBLASTOMA MULTIFORME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMANGIOMA OF SPLEEN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC ANGIOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEPATIC CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0016 events6 affected13,186 at risk
HEPATIC NEOPLASM MALIGNANT RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HODGKIN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPOPHARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOPHARYNGEAL CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INFECTED NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INTESTINAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
INTRADUCTAL PAPILLOMA OF BREAST	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
KERATOACANTHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LARGE CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARGE GRANULAR LYMPHOCYTOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events4 affected13,186 at risk
LARYNGEAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARYNGEAL CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARYNGEAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LEIOMYOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LEIOMYOSARCOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LIP AND/OR ORAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LIP NEOPLASM MALIGNANT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
LIPOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG00112 events12 affected13,186 at risk
LUNG ADENOCARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0014 events4 affected13,186 at risk
LUNG ADENOCARCINOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00027 events27 affected13,166 at risk EG00118 events18 affected13,186 at risk
LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00029 events29 affected13,166 at risk EG00129 events29 affected13,186 at risk
LUNG SQUAMOUS CELL CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0014 events4 affected13,186 at risk
LYMPHANGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LYMPHOCYTIC LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
MALIGNANT FIBROUS HISTIOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MALIGNANT GLIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0013 events3 affected13,186 at risk
MALIGNANT NEOPLASM OF EYE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MALIGNANT PLEURAL EFFUSION	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MANTLE CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MELANOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
MENINGIOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MESOTHELIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MESOTHELIOMA MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METASTASES TO BONE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
METASTASES TO CENTRAL NERVOUS SYSTEM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
METASTASES TO PERITONEUM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
METASTASIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METASTATIC BRONCHIAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METASTATIC CARCINOMA OF THE BLADDER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
METASTATIC GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0016 events6 affected13,186 at risk
METASTATIC LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0016 events6 affected13,186 at risk
METASTATIC SALIVARY GLAND CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METASTATIC SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
MONOCLONAL GAMMOPATHY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MULTIPLE MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
MYELODYSPLASTIC SYNDROME	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0011 events1 affected13,186 at risk
MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NASOPHARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NASOPHARYNGEAL CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
NEOPLASM PROSTATE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
NEUROENDOCRINE CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEUROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
NON-HODGKIN'S LYMPHOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NON-HODGKIN'S LYMPHOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NON-HODGKIN'S LYMPHOMA STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0015 events5 affected13,186 at risk
NON-SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
NON-SMALL CELL LUNG CANCER STAGE IIIB	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NON-SMALL CELL LUNG CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OESOPHAGEAL ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
OESOPHAGEAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0013 events3 affected13,186 at risk
OESOPHAGEAL SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ORAL CAVITY CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
ORAL PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OROPHARYNGEAL CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OSTEOCHONDROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OVARIAN ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OVARIAN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OVARIAN CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
OVARIAN EPITHELIAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OVARIAN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0017 events7 affected13,186 at risk
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00110 events10 affected13,186 at risk
PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PARAPROTEINAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PENIS CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PENIS CARCINOMA STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PHARYNGEAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PITUITARY TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PITUITARY TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
PLEURAL MESOTHELIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYCYTHAEMIA VERA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00054 events54 affected13,166 at risk EG00139 events38 affected13,186 at risk
PROSTATE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG0019 events9 affected13,186 at risk
PROSTATE CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROSTATE CANCER STAGE I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PROSTATE CANCER STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROSTATE CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PROSTATIC ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
RECTAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG00013 events13 affected13,166 at risk EG0014 events4 affected13,186 at risk
RECTOSIGMOID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0013 events3 affected13,186 at risk
RENAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0017 events7 affected13,186 at risk
RENAL CELL CARCINOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL ONCOCYTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RHABDOMYOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SALIVARY GLAND CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SALIVARY GLAND NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
SEBORRHOEIC KERATOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0012 events2 affected13,186 at risk
SKIN NEOPLASM BLEEDING	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SMALL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0017 events7 affected13,186 at risk
SMALL INTESTINE CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SMALL INTESTINE CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0018 events8 affected13,186 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
SQUAMOUS CELL CARCINOMA OF THE CERVIX	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
T-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
THYMOMA MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
THYROID ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
THYROID CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
TONSIL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG00110 events9 affected13,186 at risk
TRANSITIONAL CELL CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TUMOUR HAEMORRHAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
URETERAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
URETERIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
UTERINE NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VULVAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
AMYOTROPHIC LATERAL SCLEROSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
ATAXIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
AUTONOMIC NERVOUS SYSTEM IMBALANCE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BASAL GANGLIA HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BRAIN OEDEMA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRAIN STEM HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CAROTID ARTERY ANEURYSM	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CAUDA EQUINA SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
CEREBRAL AMYLOID ANGIOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CEREBRAL CYST	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0016 events6 affected13,186 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CEREBROVASCULAR INSUFFICIENCY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CERVICAL MYELOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
CERVICOBRACHIAL SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0016 events6 affected13,186 at risk
CNS VENTRICULITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COMA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
COMPLEX PARTIAL SEIZURES	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
COMPLEX REGIONAL PAIN SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
COMPLICATED MIGRAINE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
CONVULSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00027 events24 affected13,166 at risk EG00119 events18 affected13,186 at risk
CRANIAL NERVE PARALYSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
CUBITAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DEMENTIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0014 events4 affected13,186 at risk
DEMENTIA ALZHEIMER'S TYPE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
DEMYELINATING POLYNEUROPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIABETIC COMA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
DIZZINESS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG00116 events16 affected13,186 at risk
DIZZINESS EXERTIONAL	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIZZINESS POSTURAL	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DYSAESTHESIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENCEPHALITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ENCEPHALOMYELITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EPILEPSY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00015 events15 affected13,166 at risk EG00122 events20 affected13,186 at risk
FACIAL PARESIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GRAND MAL CONVULSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
GUILLAIN-BARRE SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00043 events42 affected13,166 at risk EG00175 events75 affected13,186 at risk
HAEMORRHAGIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
HAEMORRHAGIC TRANSFORMATION STROKE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0016 events6 affected13,186 at risk
HEADACHE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0007 events7 affected13,166 at risk EG00110 events9 affected13,186 at risk
HEMIANOPIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events4 affected13,186 at risk
HYDROCEPHALUS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPERTENSIVE ENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOGLYCAEMIC COMA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0010 events0 affected13,186 at risk
IIIRD NERVE PARALYSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTERCOSTAL NEURALGIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTRACRANIAL ANEURYSM	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTRACRANIAL HYPOTENSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
INTRAVENTRICULAR HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LETHARGY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LEUKOENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LEWIS-SUMNER SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
MENTAL IMPAIRMENT	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
MIGRAINE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0017 events6 affected13,186 at risk
MONOPLEGIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MYELOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MYOCLONUS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NERVE COMPRESSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
NERVE ROOT COMPRESSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEURALGIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEURITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
NEUROLOGICAL SYMPTOM	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
NORMAL PRESSURE HYDROCEPHALUS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0015 events5 affected13,186 at risk
PARAPARESIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PARAPLEGIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PARKINSON'S DISEASE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0005 events4 affected13,166 at risk EG0016 events5 affected13,186 at risk
PARKINSONISM	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PARTIAL SEIZURES	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PERIPHERAL NERVE LESION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0015 events4 affected13,186 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected13,166 at risk EG00122 events21 affected13,186 at risk
PUTAMEN HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
QUADRIPARESIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RADICULITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
RADICULOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
SCIATICA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0008 events7 affected13,166 at risk EG0012 events2 affected13,186 at risk
SEDATION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SPINAL CLAUDICATION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
SPINAL CORD COMPRESSION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
STATUS EPILEPTICUS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0015 events5 affected13,186 at risk
SYNCOPE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG00065 events60 affected13,166 at risk EG00187 events81 affected13,186 at risk
SYRINGOMYELIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TENSION HEADACHE	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
THORACIC OUTLET SYNDROME	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRANSIENT GLOBAL AMNESIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
TREMOR	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TRIGEMINAL NEURALGIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
ULNAR NEURITIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
UPPER MOTOR NEURONE LESION	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
VASCULAR DEMENTIA	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events2 affected13,186 at risk
VASCULAR PARKINSONISM	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VERTEBRAL ARTERY STENOSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VIITH NERVE PARALYSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
VOCAL CORD PARALYSIS	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
WERNICKE'S ENCEPHALOPATHY	Nervous system disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABORTION MISSED	Pregnancy, puerperium and perinatal conditions	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
ALCOHOLISM	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0004 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
ANXIETY	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0009 events9 affected13,166 at risk EG00110 events10 affected13,186 at risk
ANXIETY DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
BIPOLAR I DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0016 events6 affected13,186 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0017 events7 affected13,186 at risk
CONVERSION DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DELIRIUM	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0012 events2 affected13,186 at risk
DEPRESSED MOOD	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
DEPRESSION	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00020 events19 affected13,166 at risk EG00119 events18 affected13,186 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0018 events8 affected13,186 at risk
MANIA	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MENTAL DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0014 events4 affected13,186 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
POLYDIPSIA PSYCHOGENIC	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POST STROKE DEPRESSION	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SCHIZOPHRENIA	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SOMATOFORM DISORDER	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0002 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
STRESS	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SUBSTANCE ABUSE	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0007 events6 affected13,166 at risk EG0015 events5 affected13,186 at risk
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG00011 events11 affected13,166 at risk EG0017 events7 affected13,186 at risk
TRANSIENT PSYCHOSIS	Psychiatric disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACUTE PRERENAL FAILURE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
AZOTAEMIA	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLADDER DISORDER	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLADDER NECK OBSTRUCTION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
BLADDER NECK SCLEROSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLADDER OUTLET OBSTRUCTION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLADDER PERFORATION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLADDER PROLAPSE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
BLADDER SPASM	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BLADDER STENOSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
CALCULUS BLADDER	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0016 events6 affected13,186 at risk
CALCULUS URETHRAL	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
CALCULUS URINARY	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CYSTITIS NONINFECTIVE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIABETIC NEPHROPATHY	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
DYSURIA	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GLOMERULONEPHRITIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GLOMERULONEPHRITIS MEMBRANOUS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00042 events38 affected13,166 at risk EG00172 events66 affected13,186 at risk
HAEMORRHAGE URINARY TRACT	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0016 events5 affected13,186 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
HYDROURETER	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
KIDNEY FIBROSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
MICTURITION URGENCY	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00033 events28 affected13,166 at risk EG00122 events22 affected13,186 at risk
NEPHROPATHY	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
NEPHROTIC SYNDROME	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
OBSTRUCTIVE UROPATHY	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PELVI-URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYURIA	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL ARTERY OCCLUSION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
RENAL COLIC	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0013 events3 affected13,186 at risk
RENAL CYST	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00042 events40 affected13,166 at risk EG00134 events33 affected13,186 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00061 events54 affected13,166 at risk EG00144 events43 affected13,186 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00018 events18 affected13,166 at risk EG00113 events9 affected13,186 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
RENAL INFARCT	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
RENAL MASS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
STAG HORN CALCULUS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
STRESS URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
TUBULOINTERSTITIAL NEPHRITIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
URETERIC RUPTURE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
URETERIC STENOSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0003 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
URETHRAL OBSTRUCTION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0016 events5 affected13,186 at risk
URINARY BLADDER POLYP	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG00014 events14 affected13,166 at risk EG0014 events4 affected13,186 at risk
URINARY TRACT DISORDER	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
VESICOURETERIC REFLUX	Renal and urinary disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BALANITIS	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG00028 events27 affected13,166 at risk EG00136 events35 affected13,186 at risk
BREAST ENLARGEMENT	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
CYSTOCELE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0010 events0 affected13,186 at risk
ENDOMETRIAL HYPERPLASIA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
EPIDIDYMITIS	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
ERECTILE DYSFUNCTION	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FIBROCYSTIC BREAST DISEASE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
GENITAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
GENITAL TRACT INFLAMMATION	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MENOMETRORRHAGIA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
MENORRHAGIA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0016 events5 affected13,186 at risk
MENSTRUAL DISORDER	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
METRORRHAGIA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ORCHITIS NONINFECTIVE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
OVARIAN CYST	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
PELVIC HAEMATOMA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PELVIC PROLAPSE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POSTMENOPAUSAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROSTATIC HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROSTATISM	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0013 events3 affected13,186 at risk
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
RECTOCELE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
SPERMATOCELE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TESTICULAR OEDEMA	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
UTERINE CYST	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
UTERINE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
UTERINE PROLAPSE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
UTEROVAGINAL PROLAPSE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VAGINAL LACERATION	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VAGINAL PROLAPSE	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
VAGINAL ULCERATION	Reproductive system and breast disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0015 events5 affected13,186 at risk
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00019 events18 affected13,166 at risk EG0019 events7 affected13,186 at risk
ADENOIDAL DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
APNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ASPHYXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00013 events8 affected13,166 at risk EG00115 events12 affected13,186 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRAIN HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
BRONCHOSPASM	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events3 affected13,186 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG000100 events75 affected13,166 at risk EG001112 events79 affected13,186 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIAPHRAGMATIC PARALYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00018 events18 affected13,166 at risk EG00113 events13 affected13,186 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
DYSPNOEA PAROXYSMAL NOCTURNAL	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EOSINOPHILIC PNEUMONIA ACUTE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00016 events16 affected13,166 at risk EG00130 events29 affected13,186 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected13,166 at risk EG00113 events13 affected13,186 at risk
HAEMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0017 events7 affected13,186 at risk
HYDROTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
IDIOPATHIC PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0012 events2 affected13,186 at risk
LARYNGEAL MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LARYNGEAL STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LUNG DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
NASAL POLYPS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
NASAL SEPTUM DEVIATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0005 events5 affected13,166 at risk EG0011 events1 affected13,186 at risk
NASAL SEPTUM DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
NASAL TURBINATE HYPERTROPHY	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
OBSTRUCTIVE AIRWAYS DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
PHARYNGEAL HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 events11 affected13,166 at risk EG00114 events13 affected13,186 at risk
PLEURISY	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00015 events12 affected13,166 at risk EG0014 events4 affected13,186 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00010 events10 affected13,166 at risk EG00113 events9 affected13,186 at risk
PULMONARY CALCIFICATION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00045 events45 affected13,166 at risk EG00124 events23 affected13,186 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0013 events3 affected13,186 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
PULMONARY INFARCTION	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY NECROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0018 events8 affected13,186 at risk
RESPIRATORY ACIDOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0014 events4 affected13,186 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG00012 events12 affected13,166 at risk EG00122 events21 affected13,186 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SINUS POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0016 events6 affected13,186 at risk
TONSILLAR HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
VOCAL CORD ATROPHY	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VOCAL CORD POLYP	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ANGIODERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0006 events6 affected13,166 at risk EG0017 events7 affected13,186 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0010 events0 affected13,186 at risk
DERMATITIS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
DERMATITIS EXFOLIATIVE	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DERMATOMYOSITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DIABETIC DERMOPATHY	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
DIABETIC ULCER	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
DRY GANGRENE	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0013 events3 affected13,186 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
LEUKOCYTOCLASTIC VASCULITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PEMPHIGOID	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PEMPHIGUS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PETECHIAE	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
PURPURA	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
SCAR	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SEGMENTED HYALINISING VASCULITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SKIN HAEMORRHAGE	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
SKIN NECROSIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0010 events0 affected13,186 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0017 events7 affected13,186 at risk
STASIS DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SOCIAL PROBLEM	Social circumstances	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ABDOMINAL OPERATION	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
FINGER AMPUTATION	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
GASTRIC BANDING	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
INGUINAL HERNIA REPAIR	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POLYPECTOMY	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SPINAL DECOMPRESSION	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SURGERY	Surgical and medical procedures	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ACCELERATED HYPERTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANEURYSM	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ANEURYSM RUPTURED	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ANGIODYSPLASIA	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00018 events18 affected13,166 at risk EG00118 events18 affected13,186 at risk
AORTIC ANEURYSM RUPTURE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0008 events8 affected13,166 at risk EG0015 events3 affected13,186 at risk
AORTIC DILATATION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0003 events3 affected13,166 at risk EG0017 events7 affected13,186 at risk
ARTERIAL DISORDER	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
ARTERIAL RUPTURE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events1 affected13,186 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
BLEEDING VARICOSE VEIN	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0013 events2 affected13,186 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00023 events22 affected13,166 at risk EG00120 events19 affected13,186 at risk
ESSENTIAL HYPERTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0012 events2 affected13,186 at risk
EXTREMITY NECROSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
FEMORAL ARTERY ANEURYSM	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HAEMATOMA	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00017 events16 affected13,166 at risk EG00126 events25 affected13,186 at risk
HAEMODYNAMIC INSTABILITY	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00024 events23 affected13,166 at risk EG00140 events36 affected13,186 at risk
HYPERTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00026 events26 affected13,166 at risk EG00132 events27 affected13,186 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00035 events31 affected13,166 at risk EG00125 events20 affected13,186 at risk
HYPERTENSIVE EMERGENCY	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0004 events4 affected13,166 at risk EG0015 events4 affected13,186 at risk
HYPOPERFUSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
HYPOTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00029 events29 affected13,166 at risk EG00131 events31 affected13,186 at risk
HYPOVOLAEMIC SHOCK	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0012 events2 affected13,186 at risk
INTRA-ABDOMINAL HAEMORRHAGE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LABILE BLOOD PRESSURE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LYMPHATIC FISTULA	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
LYMPHOCELE	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
LYMPHOEDEMA	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
ORTHOSTATIC HYPERTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG00020 events20 affected13,166 at risk EG00115 events13 affected13,186 at risk
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk
PERIPHERAL EMBOLISM	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
PHLEBITIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
POOR PERIPHERAL CIRCULATION	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
RAYNAUD'S PHENOMENON	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
SHOCK	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
SUBCLAVIAN VEIN THROMBOSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0010 events0 affected13,186 at risk
TEMPORAL ARTERITIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0011 events1 affected13,186 at risk
VARICOSE VEIN	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0013 events3 affected13,186 at risk
VENOUS INSUFFICIENCY	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0000 events0 affected13,166 at risk EG0011 events1 affected13,186 at risk
VENOUS THROMBOSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0002 events2 affected13,166 at risk EG0012 events2 affected13,186 at risk
WEGENER'S GRANULOMATOSIS	Vascular disorders	MedDRA 14.1	Systematic Assessment	EG0001 events1 affected13,166 at risk EG0011 events1 affected13,186 at risk

ID	Type	Description
TRA 2°P - TIMI 50
2006-002942-12
MK-5348-015	Other Identifier	Merck Study Number

ID	Term
D050197	Atherosclerosis
D007511	Ischemia
D009203	Myocardial Infarction
D020521	Stroke
D058729	Peripheral Arterial Disease

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017202	Myocardial Ischemia
D006331	Heart Diseases
D007238	Infarction
D009336	Necrosis
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016491	Peripheral Vascular Diseases

ID	Title	Description
BG000	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
BG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
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	Placebo	1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.			3,419	13,166	2,280	13,166
EG001	Vorapaxar	one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.			3,514	13,186	2,541	13,186