INFUSE® Bone Graft/ PEEK Interbody Spacer/ Anterior Cervi... | NCT00485173

Label	Type	Description	Intervention Names
INFUSE® Bone Graft	Experimental	In this arm, patients will receive implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.	Device: INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate

Name	Type	Description	Arm Group Labels	Other Names
INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate	Device	All patients enrolled in this study will receive the investigational device.	INFUSE® Bone Graft

Measure	Description	Time Frame
Rate of Overall Success	Rate of overall success is reported as the percentage of participants who met all of the following criteria: fusion at the treated level; pain/disability (Neck Disability Index) success; neurological status success; no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;" no additional surgical procedure classified as a "failure."	24 months post-operation

Measure	Description	Time Frame
Success Rate of Fusion	Success Rate of Fusion is reported as percent of participants who met the following fusion criteria: Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer. No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface. No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).

Measure	Description	Time Frame
Neck Disability Index Score	The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).	24 months post-operation
Neck Pain Score

Facility	Status	City	State	ZIP	Country	Contacts
S & B Surgery Center		Beverly Hills	California	90210	United States
Orange County Neurological Association

ID	Title	Description
FG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
FG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

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

Rate of Overall Success

Rate of overall success is reported as the percentage of participants who met all of the following criteria:

fusion at the treated level;
pain/disability (Neck Disability Index) success;
neurological status success;
no serious adverse event classified as "implant associated" or "implant/surgical procedure associated;"
no additional surgical procedure classified as a "failure."

Primary dataset (including all subjects who received study devices. Missing observations were not imputed.)

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000162 OG001352

Title

Denominators

Categories

Title	Measurements
	OG00080.9 OG00159.9

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		Regression, Logistic		<0.001	P-value was one-sided from random samplings, based on logistic regression model by using propensity score as a covariate.						95						Yes	Non-Inferiority or Equivalence	The predefined non-inferiority margin was 0.10.
OG000 OG001

Secondary

Success Rate of Fusion

Success Rate of Fusion is reported as percent of participants who met the following fusion criteria:

Evidence of bridging bone. This is based on the evidence of a continuous bony connection from the superior vertebral body to the inferior vertebral body in at least one of the following areas: lateral, anterior, posterior and/or through the PEEK spacer.
No evidence of radiolucency at greater than 50% of the superior or inferior PEEK spacer-vertebra interface.
No evidence of motion as defined by ≤ 4º of angular motion (based on flexion-extension lateral plain radiographs).

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts

Other Pre-specified

Neck Disability Index Score

The self-administered Neck Disability Index (NDI) Questionnaire was used to assess patient neck pain and ability to function. The NDI scale ranges from 0-100. The best score is 0 (no disability) and worst is 100 (maximum disability).

Primary dataset.

Posted

Mean

Standard Deviation

units on a scale

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Success Rate of Neck Disability Index

Success rate of Neck Disability Index is reported as the percentage of participants whose neck disability index score met: Pre-treatment Score - Post-treatment Score ≥ 15.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Other Pre-specified

Neck Pain Score

Numerical rating scales are used to evaluate neck pain intensity and frequency. Patients rate their neck pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their neck pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total neck pain score is the sum of pain intensity and frequency scores.

Primary dataset.

Posted

Mean

Standard Deviation

units on a scale

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants

Secondary

Success Rate of Neurological Status

Success rate of neurological status is reported as the percentage of participants who met neurological success defined as maintenance or improvement in all sections (motor, sensory, and reflexes) for the time period evaluated. In order for a section to be considered a success, each element in the section must remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants

Other Pre-specified

Arm Pain Score

Numerical rating scales are used to evaluate arm pain intensity and frequency. Patients rate their arm pain intensity on a scale from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be." Similarly, patients record their arm pain frequency on a scale from 0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time." The total arm pain score will be the sum of pain intensity and frequency scores.

Primary dataset.

Posted

Mean

Standard Deviation

units on a scale

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants

Secondary

Neck Pain Success Rate

Neck pain success rate is reported as the percentage of participants whose neck pain improvement met: Preoperative Score - Postoperative Score > 0.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Other Pre-specified

General Health Status -- SF-36 PCS

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS is between 0 and 100, with higher scores denoting better quality of life.

Primary dataset.

Posted

Mean

Standard Deviation

units on a scale

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants

Secondary

Arm Pain Success Rate

Arm pain success rate is reported as the percentage of participants whose arm pain improvement met: Preoperative Score - Postoperative Score > 0.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Other Pre-specified

General Health Status -- SF-36 MCS

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results are summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS is between 0 and 100, with higher scores denoting better quality of life.

Primary dataset.

Posted

Mean

Standard Deviation

units on a scale

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants

Secondary

Success Rate of SF-36 PCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rate of SF-36 PCS was defined as: Post Score - Pre Score >= 0.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Success Rate of SF-36 MCS

Success rate of SF-36 Health Survey include two components: the success rate of a physical component summary (PCS) and the success rate of a mental component summary (MCS). The success rates of SF-36 MCS were defined as: Post Score - Pre Score >= 0.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Operative Time

Operative time was recorded from skin incision to wound closure.

Primary dataset.

Posted

Mean

Standard Deviation

hrs

Time of operation, approximately 1.5 hrs.

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Blood Loss

Primary dataset.

Posted

Mean

Standard Deviation

During the time of operation, approximately 1.5 hours.

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Hospital Stay

Primary dataset.

Posted

Mean

Standard Deviation

days

During the time of hospital stay, average of 1 day.

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Secondary

Number of Patients Who Had Secondary Surgeries at the Index Level

Secondary surgical procedures at the index level included revisions, removal, supplemental fixation and reoperations.

Posted

Number

participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Other Pre-specified

Ossification in the Region of Target Level

Ossification in the region of target level is reported as the percentage of the patients who had ossification in the region of the target level. The region of target level included the index level, the superior and inferior adjacent disc spaces, and the superior and inferior adjacent vertebral bodies.

Primary dataset.

Posted

Number

percentage of participants

24 months post-operation

ID	Title	Description
OG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
OG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Myoccardial Infarction	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Angina Pectoris	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Atrial Flutter	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Cardiomegaly	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Palpitations	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Autoimmune Thyroiditis	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Thyroid Cyst	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Astigmatism	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Cataract	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Ectropion	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Lacrimation Increased	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Visual Impairment	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Gastrointestinal Ulcer	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Ileus	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Intestinal Perforation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Oesophageal Fistula	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Proctalgia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0012 events2 affected486 at risk
Accidental Death	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Adverse Drug Reaction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Asthenia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Axillary Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Chest Discomfort	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Device Breakage	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Facial Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Gait Disturbance	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Hernia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Local Swelling	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0010 events0 affected486 at risk
Oedema Peripheral	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Soft Tissue Inflammation	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Spinal Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Gallbladder Disorder	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Immunodeficiency Common Variable	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Sarcoidosis	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bacterial Sepsis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected486 at risk
Extradural Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Kidney Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Meningitis Herpes	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Paraoesophageal Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Pyelonephritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Sepsis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Wound Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Accident At Work	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Bone Fragmentation	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Epidural Fibrosis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Eye Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected224 at risk EG0016 events6 affected486 at risk
Gastrointestinal Anastomotic Leak	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Intervertebral Disc Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0014 events4 affected486 at risk
Multiple Drug Overdose Accidental	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nerve Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Post Laminectomy Syndrome	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Post-Traumatic Neck Syndrome	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Procedural Headache	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pubis Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected224 at risk EG0015 events5 affected486 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Tracheal Deviation	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pancreatic Enzymes Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
White Blood Cell Count Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events2 affected486 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected224 at risk EG0018 events8 affected486 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG00115 events15 affected486 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Compartment Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG00116 events12 affected486 at risk
Facet Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events9 affected224 at risk EG00118 events18 affected486 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0014 events4 affected486 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00015 events15 affected224 at risk EG00135 events32 affected486 at risk
Intervertebral Disc Space Narrowing	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Joint Crepitation	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Joint Range Of Motion Decreased	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Ligament Disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Limb Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG00110 events10 affected486 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events4 affected486 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG00113 events11 affected486 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events6 affected224 at risk EG00118 events16 affected486 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events3 affected224 at risk EG0012 events2 affected486 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0019 events9 affected486 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG00116 events16 affected486 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events5 affected224 at risk EG00112 events11 affected486 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0018 events8 affected486 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0011 events1 affected486 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events1 affected486 at risk
Tendon Disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Vertebral Foraminal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0014 events4 affected486 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Fibrous Histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Myolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Skin Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Amnesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Arachnoid Cyst	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Burning Sensation	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG00110 events10 affected486 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Cervical Cord Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0017 events7 affected486 at risk
Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected486 at risk
Dysaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Dyskinesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0015 events5 affected486 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0019 events8 affected486 at risk
Hypokinesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hypoxic-Ischaemic Encephalopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Migraine	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Myelitis Transverse	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Myelopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Nerve Root Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0014 events4 affected486 at risk
Perineurial Cyst	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Radicular Pain	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0017 events7 affected486 at risk
Radiculopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Sciatica	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sensory Loss	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Spinal Cord Ischaemia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Spinal Cord Oedema	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Thoracic Outlet Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Tremor	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events1 affected486 at risk
Ulnar Nerve Palsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Foetal Hypokinesia	Pregnancy, puerperium and perinatal conditions	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Premature Labour	Pregnancy, puerperium and perinatal conditions	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Abnormal Behaviour	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Alcohol Abuse	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Schizophrenia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Stress	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Suicidal Behaviour	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Calculus Ureteric	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Cystitis Interstitial	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Neurogenic Bladder	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Scrotal Pain	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Testicular Torsion	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Foreign Body Aspiration	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pharyngeal Haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pulmonary Sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Vocal Cord Polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Keloid Scar	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Face Lift	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Gastric Bypass	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Tonsillectomy	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Venous Operation	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Aortic Stenosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haematoma	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Orthostatic Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Peripheral Artery Aneurysm	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected486 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0011 events1 affected486 at risk
Lymph Node Pain	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Splenomegaly	Blood and lymphatic system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Bradycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Palpitations	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0015 events5 affected486 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Deafness	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0010 events0 affected486 at risk
Hearing Impaired	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hyperacusis	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Vestibular Disorder	Ear and labyrinth disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Autoimmune Thyroiditis	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Goitre	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Astigmatism	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Cataract	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Conjunctivitis	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Diplopia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Eye Pain	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Photophobia	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Vision Blurred	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Visual Impairment	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Vitreous Floaters	Eye disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Abdominal Adhesions	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0013 events3 affected486 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Breath Odour	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Change Of Bowel Habit	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0012 events2 affected486 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG00037 events34 affected224 at risk EG00136 events34 affected486 at risk
Epigastric Discomfort	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Eructation	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Faecal Incontinence	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0017 events7 affected486 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Intestinal Polyp	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Irritable Bowel Syndrome	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Malocclusion	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected224 at risk EG0018 events8 affected486 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Oesophageal Oedema	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Periodontal Disease	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Polyp Colorectal	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Tongue Discolouration	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Toothache	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0015 events5 affected486 at risk
Adverse Drug Reaction	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Asthenia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events5 affected224 at risk EG0010 events0 affected486 at risk
Axillary Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Chest Discomfort	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG00110 events10 affected486 at risk
Chills	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Crepitations	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Device Breakage	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Device Connection Issue	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Device Dislocation	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Drug Withdrawal Syndrome	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Facial Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Fatigue	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected224 at risk EG0011 events1 affected486 at risk
Feeling Cold	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Gait Disturbance	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Implant Site Paraesthesia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Infusion Site Extravasation	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Irritability	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Local Swelling	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG0014 events4 affected486 at risk
Malaise	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Oedema Peripheral	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected224 at risk EG0012 events2 affected486 at risk
Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0013 events3 affected486 at risk
Pyrexia	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0013 events3 affected486 at risk
Sensation Of Foreign Body	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Sensation Of Pressure	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Spinal Pain	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Swelling	General disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Latex Allergy	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Seasonal Allergy	Immune system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Adenoviral Conjunctivitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Bacterial Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Breast Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bronchitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0011 events1 affected486 at risk
Cellulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Diverticulitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Ear Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Gastrointestinal Bacterial Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Herpes Zoster	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Hordeolum	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Incision Site Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Influenza	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events3 affected486 at risk
Kidney Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Laryngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Otitis Media	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pertussis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Pharyngitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pneumonia	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Pneumonia Primary Atypical	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Post Procedural Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Reiter's Syndrome	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Rhinitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sinusitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0006 events6 affected224 at risk EG0015 events5 affected486 at risk
Staphylococcal Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Stitch Abscess	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Tonsillitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Tracheitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Tracheobronchitis	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected486 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Arthropod Sting	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Dural Tear	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Electric Shock	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Endotracheal Intubation Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Epicondylitis	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events4 affected486 at risk
Face Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG00010 events10 affected224 at risk EG00128 events27 affected486 at risk
Foreign Body	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events1 affected224 at risk EG0010 events0 affected486 at risk
Graft Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0016 events5 affected486 at risk
Incision Site Complication	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Incision Site Erythema	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0010 events0 affected486 at risk
Incision Site Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Incision Site Oedema	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected224 at risk EG0010 events0 affected486 at risk
Incision Site Pain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Incorrect Dose Administered	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Intervertebral Disc Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events4 affected486 at risk
Limb Crushing Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0017 events7 affected486 at risk
Nail Avulsion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Neck Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Periorbital Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Post Laminectomy Syndrome	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Post Procedural Constipation	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Post-Traumatic Neck Syndrome	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Procedural Dizziness	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Procedural Headache	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Procedural Hypertension	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Procedural Nausea	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0015 events5 affected486 at risk
Procedural Vomiting	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0015 events5 affected486 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG00115 events15 affected486 at risk
Spondylopathy Traumatic	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sports Injury	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Tracheal Deviation	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Wound Contamination	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Wound Secretion	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Blood Cholesterol Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Blood Pressure Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Blood Sodium Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Blood Triglycerides Increased	Injury, poisoning and procedural complications	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
C-Reactive Protein Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Colonoscopy	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Electrocardiogram T Wave Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haematocrit Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haemoglobin Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Heart Rate Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Intraocular Pressure Test Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Oxygen Saturation Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Red Blood Cell Sedimentation Rate Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Reflex Test Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Sleep Study Abnormal	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Transaminases Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Urine Output Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Weight Decreased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
White Blood Cell Count Increased	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Gout	Investigations	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0015 events5 affected486 at risk
Ankylosing Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG00114 events14 affected486 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00034 events29 affected224 at risk EG00147 events44 affected486 at risk
Bone Cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bone Deformity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Bunion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0013 events3 affected486 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0016 events6 affected486 at risk
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG00113 events12 affected486 at risk
Facet Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events4 affected486 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Intervertebral Disc Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00015 events12 affected224 at risk EG00121 events20 affected486 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0014 events4 affected486 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00021 events18 affected224 at risk EG00127 events26 affected486 at risk
Intervertebral Disc Space Narrowing	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0010 events0 affected486 at risk
Joint Crepitation	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0014 events3 affected486 at risk
Joint Hyperextension	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Joint Laxity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Joint Lock	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Joint Range Of Motion Decreased	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0014 events4 affected486 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0013 events3 affected486 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Limb Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Meniscal Degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Muscle Atrophy	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Muscle Fatigue	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00024 events21 affected224 at risk EG00146 events40 affected486 at risk
Muscle Tightness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events4 affected224 at risk EG00113 events11 affected486 at risk
Muscle Twitching	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG00112 events10 affected486 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00013 events11 affected224 at risk EG00112 events11 affected486 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00042 events37 affected224 at risk EG00177 events67 affected486 at risk
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 events9 affected224 at risk EG00124 events21 affected486 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG00127 events24 affected486 at risk
Myofascial Pain Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0015 events5 affected486 at risk
Myofascial Spasm	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Neck Mass	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00068 events63 affected224 at risk EG001122 events106 affected486 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0016 events5 affected486 at risk
Osteochondritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00037 events33 affected224 at risk EG00172 events64 affected486 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Patellofemoral Pain Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Plantar Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG00129 events29 affected486 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG00110 events10 affected486 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Sensation Of Heaviness	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Soft Tissue Disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG00012 events10 affected224 at risk EG00116 events11 affected486 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0012 events2 affected486 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Temporomandibular Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0014 events4 affected486 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0011 events1 affected486 at risk
Trigger Finger	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Vertebral Foraminal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0009 events9 affected224 at risk EG0012 events2 affected486 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Colon Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Fibrous Cortical Defect	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Melanocytic Naevus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Nervous System Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Spinal Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Allodynia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Amnesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Arachnoid Cyst	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Balance Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Burning Sensation	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0017 events7 affected486 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 events10 affected224 at risk EG00116 events16 affected486 at risk
Cerebral Ischaemia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cervical Myelopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0015 events5 affected486 at risk
Cervicogenic Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Coordination Abnormal	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cubital Tunnel Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Dizziness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG0018 events7 affected486 at risk
Dizziness Postural	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Dysaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0013 events3 affected486 at risk
Dyskinesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Grand Mal Convulsion	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00026 events25 affected224 at risk EG00141 events39 affected486 at risk
Horner's Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hyperaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Hyperpathia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hyperreflexia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Hypersomnia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00042 events34 affected224 at risk EG00197 events71 affected486 at risk
Intracranial Hypotension	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Memory Impairment	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Migraine	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0016 events6 affected486 at risk
Muscle Contractions Involuntary	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Myelopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Narcolepsy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nerve Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Nerve Root Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Nervous System Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Neuralgia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Neuritis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG00025 events21 affected224 at risk EG00151 events45 affected486 at risk
Peripheral Motor Neuropathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Piriformis Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Polyneuropathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Poor Quality Sleep	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Post-Traumatic Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Presyncope	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Radicular Pain	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG00121 events21 affected486 at risk
Radicular Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Radiculopathy	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Sciatica	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0012 events2 affected486 at risk
Sensory Disturbance	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Sensory Loss	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0015 events5 affected486 at risk
Sinus Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Spinal Cord Compression	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Spinal Cord Disorder	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Syncope	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Tension Headache	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Thoracic Outlet Syndrome	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Tremor	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0012 events2 affected486 at risk
Ulnar Neuritis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Viith Nerve Paralysis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Vocal Cord Paralysis	Nervous system disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Gestational Diabetes	Pregnancy, puerperium and perinatal conditions	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Affect Lability	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Anxiety	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0018 events7 affected486 at risk
Bipolar I Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Confusional State	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Delirium	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Depression	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG00010 events10 affected224 at risk EG00110 events10 affected486 at risk
Disorientation	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Insomnia	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0008 events8 affected224 at risk EG0017 events7 affected486 at risk
Libido Decreased	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Mood Swings	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Panic Attack	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0012 events2 affected486 at risk
Stress	Psychiatric disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0011 events1 affected486 at risk
Dysuria	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Enuresis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Hydroureter	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Incontinence	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0012 events2 affected486 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0014 events4 affected486 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Breast Mass	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Menopausal Symptoms	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Uterine Polyp	Reproductive system and breast disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Bronchial Hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Choking	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events4 affected224 at risk EG0012 events2 affected486 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0004 events3 affected224 at risk EG0016 events6 affected486 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0012 events2 affected486 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Increased Upper Airway Secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Laryngeal Erythema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Laryngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Nasal Cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Nasal Inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Oropharyngeal Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0007 events7 affected224 at risk EG0012 events2 affected486 at risk
Painful Respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pharyngeal Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Pharyngeal Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0013 events3 affected486 at risk
Pulmonary Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events2 affected224 at risk EG0010 events0 affected486 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Sinus Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0003 events3 affected224 at risk EG0010 events0 affected486 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Throat Tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Vocal Cord Thickening	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Dermatitis Acneiform	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0013 events3 affected486 at risk
Dermatitis Exfoliative	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0013 events3 affected486 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Leukoplakia	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0011 events1 affected486 at risk
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Scar	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0012 events2 affected486 at risk
Skin Burning Sensation	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Skin Discolouration	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Physical Assault	Social circumstances	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Arthrodesis	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Suture Removal	Surgical and medical procedures	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Flushing	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0010 events0 affected486 at risk
Haematoma	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Hypertension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0005 events5 affected224 at risk EG0016 events6 affected486 at risk
Hypotension	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0001 events1 affected224 at risk EG0011 events1 affected486 at risk
Peripheral Coldness	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0000 events0 affected224 at risk EG0011 events1 affected486 at risk
Thrombophlebitis Superficial	Vascular disorders	MedDRA 15.0	Non-systematic Assessment	EG0002 events2 affected224 at risk EG0010 events0 affected486 at risk

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Title	Description
BG000	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
BG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
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	INFUSE® Bone Graft	In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.			71	224	186	224
EG001	Historical Control	Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).			159	486	371	486