Study of the Safety and Effectiveness of the Artificial C... | NCT00637156

Label	Type	Description	Intervention Names
PRESTIGE LP Device	Experimental		Device: PRESTIGE LP device at two adjacent levels
ATLANTIS Cervical Plate System	Other		Device: Bi-level fusion with ATLANTIS Cervical Plate System

Name	Type	Description	Arm Group Labels	Other Names
PRESTIGE LP device at two adjacent levels	Device	PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.

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: Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative; Maintenance or improvement in neurological status; No serious adverse event classified as implant associated or implant/surgical procedure associated; and No additional surgical procedure classified as a "failure."	24 Months

Measure	Description	Time Frame
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 the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.	24 months
Success Rate of Neurological Status

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has cervical DDD at 2 adjacent cervical levels (C3-C7) requiring surgical treatment & involving intractable radiculopathy, myelopathy, or both
Has a herniated disc and/or osteophyte formation at each level to be treated that is producing symptomatic nerve root and/or spinal cord compression. The condition is documented by patient history, and the requirement for surgical treatment is evidenced by radiographic studies
Unresponsive to non-operative treatment for approximately 6 weeks or has the presence of progressive symptoms or signs of nerve root/spinal cord compression in the face of continued non-operative management
Has no previous surgical intervention at the involved levels or any subsequent planned/staged surgical procedure at the involved or adjacent level(s)
Must be ≥ 18 years; skeletally mature at time of surgery
Preoperative NDI score ≥ 30
Preoperative neck pain score ≥ 8 based on the preoperative Neck and Arm Pain Questionnaire
If a female of childbearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant during the study period
Is willing to comply with the study plan and sign Patient Informed Consent Form

Exclusion Criteria:

Has a cervical spinal condition other than symptomatic cervical DDD requiring surgical treatment at the involved levels
Has documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion/extension) radiographs showing: Sagittal plane translation > 3.5 mm, or Sagittal plane angulation > 20 degrees.
Has more than two cervical levels requiring surgical treatment
Has a fused level adjacent to the levels to be treated
Has severe pathology of the facet joints of the involved vertebral bodies
Has had previous surgical intervention at either one or both of the involved levels or at adjacent levels
Has been previously diagnosed with osteopenia or osteomalacia
Has any of the following that may be associated with a diagnosis of osteoporosis (If "Yes" to any of the below a DEXA Scan will be required to determine eligibility.)
- Postmenopausal non-Black female over age of 60 who weighs < 140 pounds
- Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture
- Male > 70 years
- Male > 60 years who has sustained a non-traumatic hip or spine fracture
- If the level of BMD is a T score of -3.5 or lower or a T score of -2.5 or lower with vertebral crush fracture, then the patient is excluded from the study
Has presence of spinal metastases
Has overt or active bacterial infection, either local or systemic
Has insulin dependent diabetes
Is a tobacco user who does not agree to suspend smoking prior to surgery
Has chronic or acute renal failure or prior history of renal disease
Has a documented allergy or intolerance to stainless steel, titanium, or a titanium alloy
Is mentally incompetent (If questionable, obtain psychiatric consult)
Is a prisoner
Is pregnant
Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
Is involved with current or pending litigation regarding a spinal condition
Has received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate), excluding routine perioperative anti-inflammatory drugs
Has a history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers-Danlos Syndrome, or osteogenesis imperfecta)
Has a condition that requires postoperative medications that interfere with the stability of the implant, such as steroids. (This does not include low-dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs.)
Has received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation

Name	Affiliation	Role
John K Burkus, M.D.	The Hughston Clinic, P.C.	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The Orthopaedic Center; Crestwood Medical Center		Huntsville	Alabama	35801	United States
Todd Lanman, MD, FACS, A Professional Corp.;

PubMed Identifier	Type	Citation	Retractions
31970051	Derived	Gornet MF, Lanman TH, Burkus JK, Hodges SD, McConnell JR, Dryer RF, Schranck FW, Copay AG. One-Level Versus 2-Level Treatment With Cervical Disc Arthroplasty or Fusion: Outcomes Up to 7 Years. Int J Spine Surg. 2019 Dec 31;13(6):551-560. doi: 10.14444/6076. eCollection 2019 Dec.
31226684	Derived	Gornet MF, Lanman TH, Burkus JK, Dryer RF, McConnell JR, Hodges SD, Schranck FW. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. 2019 Jun 21;31(4):508-518. doi: 10.3171/2019.4.SPINE19157. Print 2019 Oct 1.

ID	Title	Description
FG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
FG001

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:

Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;
Maintenance or improvement in neurological status;
No serious adverse event classified as implant associated or implant/surgical procedure associated; and
No additional surgical procedure classified as a "failure."

The primary analysis dataset for this study included all subjects who received study devices and completed the initial surgical procedures. The analysis was based on the observed data and missing data due to lost-to-follow-ups were imputed. For the primary endpoint, the analysis consists of 199 investigational subjects and 160 control subjects.

Posted

Number

percentage of participants

24 Months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants	OG000199 OG001160

Title

Denominators

Categories

Title	Measurements
	OG00081.4 OG00169.4

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	The null hypothesis H0: p1 + d ≤ p0, and the alternative hypothesis is Ha: p1 + d > p0 where P0 and P1 are the overall success rates in the control group and the investigational group respectively, and d is the non-inferiority margin. The analyses used Bayesian methodology. Should the posterior probability P(p1 - p0 > -d \| data) be at least 0.95, then the null non-inferiority hypothesis will be rejected, and non-inferiority of the investigational device to the control will be claimed.	Bayesian model		1.000	The posterior probability of non-inferiority was calculated and presented instead of the p-value.	Risk Difference (RD)	0.113			2-Sided	95	0.022	0.201			The posterior mean of P1-P0, along with the corresponding 95% highest posterior density (HPD) interval, was presented instead of the usual 95% CI.

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 the following criterion: Pre-treatment Score - Post-treatment Score ≥ 15.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable NDI success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

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 either remain the same or improve from the time of the preoperative evaluation to the time period evaluated.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neurological success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Neck Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Neck pain success rate is reported as the percentage of participants whose neck pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable neck pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Arm Pain Success Rate

Numerical rating scales were used to evaluate pain intensity and frequency. The pain score (0 min, 20 max) was derived by adding the numerical rating scores from the pain intensity (0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be.") and frequency scales (0-10, with a score of 0 being "pain none of the time" and a score of 10 being "pain all of the time"). Arm pain success rate is reported as the percentage of participants whose arm pain improvement met the following criterion: Preoperative Score - Postoperative Score > 0.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable arm pain success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

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 of SF-36 PCS was defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 PCS is reported as the percentage of the participants who were classified as a success for SF-36 PCS.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 PCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

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 of SF-36 MCS were defined as: Post Score - Pre Score >= 0. The Success rate of SF-36 MCS is reported as the percentage of the participants who were classified as a success for SF-36 MCS.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable SF-36 MCS success status at 24 months, which leads to 197 subjects in the investigational group and 156 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Rate of Disc Height Success

Disc height was assessed by determining the Functional Spinal Unit (FSU) height. The rate of disc height success is reported as the percentage of participants whose disc height for each level based on either the anterior or posterior measurements met the following criterion: Postoperative Height - 6 Week Postoperative Height >= -2mm

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable disc height success (FSU success) status at 24 months, which leads to 170 subjects in the investigational group and 138 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units

Secondary

Gait Success Rate

Patient's gait was assessed by using Nurick's classification, and indicated either as normal or graded on a scale of 0 to 5. Success was defined as maintenance or improvement in the postoperative status as compared to the preoperative condition: Preoperative Score - Postoperative Score >= 0. The gait success rate is reported as the percentage of participants who had gait success.

For this endpoint, the analysis consists of subjects in the primary analysis dataset with evaluable gait success status at 24 months, which leads to 199 subjects in the investigational group and 159 subjects in the control group.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Operative Time

Operative time was recorded from skin incision to wound closure.

Posted

Mean

Standard Deviation

hrs

Time of operation, an average of 1.7-2.1hrs

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants	OG000

Secondary

Blood Loss

Posted

Mean

Standard Deviation

During the time of operation, an average of 1.7-2.1 hrs

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants	OG000

Secondary

Hospital Stay

Posted

Mean

Standard Deviation

days

From admission to discharge, an average of 1.0-1.5 day

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants	OG000

Secondary

Rate of Secondary Surgery at Index Level

Secondary surgical procedures at the index level included revisions, removals, supplemental fixations and reoperations. Rate of secondary surgery at index level is reported as percentage of subjects who had secondary surgeries at index level.

Posted

Number

percentage of participants

24 months

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants	OG000

Secondary

Change of Neck Disability Index Score From Baseline

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). Change of NDI was defined as NDI at 24 month minus NDI at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 24 months post-operation

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants

Secondary

Change of Neck Pain Score From Baseline

Numerical rating scales were used to evaluate neck pain intensity and frequency. Subjects rated 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, subjects recorded 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 (0 to 20) was the addition of pain intensity and frequency scores. Change of neck pain score was defined as neck pain score at 24 months minus neck pain score at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 24 months post-operation

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Change of Arm Pain Score From Baseline

Numerical rating scales were also used to evaluate arm pain intensity and frequency. Subjects rated 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, subjects recorded 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 (0 to 20) was the addition of pain intensity and frequency scores. Change of arm pain score was defined as arm pain score at 24 months minus arm pain score at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 24 months post-operation

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Secondary

Change of General Health Status -- SF-36 PCS From Baseline

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for PCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 PCS score was defined as PCS score at 24 months minus PCS score at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 24 months post-operation

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants

Secondary

Change of General Health Status -- SF-36 MCS From Baseline

The Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) was used to assess general health status. The SF-36 results were summarized into two components, a physical component summary (PCS) and a mental component summary (MCS). The score for MCS was between 0 and 100, with higher scores denoting better quality of life. Change of SF-36 MCS score was defined as MCS score at 24 months minus MCS score at baseline.

Posted

Mean

Standard Deviation

units on a scale

Baseline and 24 months post-operation

ID	Title	Description
OG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
OG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lymphadenopathy	Blood and lymphatic system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Acute myocardial infarction	Cardiac disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Aortic valve incompetence	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cardiac arrest	Cardiac disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Coronary artery disease	Cardiac disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Mitral valve incompetence	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Myocardial ischaemia	Cardiac disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Palpitations	Cardiac disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Sinus bradycardia	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tachycardia	Cardiac disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Tricuspid valve incompetence	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Ventricular tachycardia	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Arnold-Chiari malformation	Congenital, familial and genetic disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Chronic granulomatous disease	Congenital, familial and genetic disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Myocardial bridging	Congenital, familial and genetic disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Spine malformation	Congenital, familial and genetic disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Vertigo	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Thyrotoxic crisis	Endocrine disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Blindness	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cataract subcapsular	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Conjunctivitis	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Abdominal adhesions	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Abdominal pain	Gastrointestinal disorders	EG0005 events4 affected209 at risk EG0010 events0 affected188 at risk
Abdominal pain lower	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Abdominal pain upper	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Anal fistula	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Constipation	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Diarrhoea	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Dyspepsia	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dysphagia	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Gastritis	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Impaired gastric emptying	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Inguinal hernia	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Mesenteric occlusion	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Nausea	Gastrointestinal disorders	EG0004 events3 affected209 at risk EG0017 events7 affected188 at risk
Oesophageal disorder	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Pancreatitis	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Small intestinal obstruction	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tooth loss	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Toothache	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vomiting	Gastrointestinal disorders	EG0003 events3 affected209 at risk EG0014 events4 affected188 at risk
Abasia	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Adverse drug reaction	General disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Chest discomfort	General disorders	EG0002 events1 affected209 at risk EG0010 events0 affected188 at risk
Chest pain	General disorders	EG0006 events6 affected209 at risk EG0014 events4 affected188 at risk
Chills	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cyst	General disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Death	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Device breakage	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Device connection issue	General disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Device dislocation	General disorders	EG0003 events3 affected209 at risk EG0014 events4 affected188 at risk
Facial pain	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Fatigue	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Feeling abnormal	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gait disturbance	General disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Hernia	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pain	General disorders	EG0001 events1 affected209 at risk EG0014 events4 affected188 at risk
Pyrexia	General disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Sensation of pressure	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Spinal pain	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Biliary dyskinesia	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cholecystitis	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cholecystitis acute	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Cholelithiasis	Hepatobiliary disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Bronchitis	Infections and infestations	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Cellulitis	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Diverticulitis	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Enterobacter infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastroenteritis	Infections and infestations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Gastroenteritis viral	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Helicobacter infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Lyme disease	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Perirectal abscess	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pneumonia	Infections and infestations	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Pyelonephritis	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pyelonephritis acute	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Respiratory tract infection	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Sinusitis	Infections and infestations	EG0003 events2 affected209 at risk EG0010 events0 affected188 at risk
Skin graft infection	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Urinary tract infection	Infections and infestations	EG0003 events2 affected209 at risk EG0014 events4 affected188 at risk
Accident	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Burns third degree	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cartilage injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Concussion	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Contusion	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0014 events3 affected188 at risk
Corneal abrasion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cranial nerve injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Dural tear	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Excoriation	Injury, poisoning and procedural complications	EG0003 events1 affected209 at risk EG0012 events2 affected188 at risk
Fall	Injury, poisoning and procedural complications	EG0008 events7 affected209 at risk EG00111 events10 affected188 at risk
Flatback syndrome	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Foot fracture	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Head injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Injury	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Joint dislocation	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Joint injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Kyphosis postoperative	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Laceration	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0015 events4 affected188 at risk
Ligament injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Limb crushing injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Limb injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Lip injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Meniscus lesion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nail avulsion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Open wound	Injury, poisoning and procedural complications	EG0002 events1 affected209 at risk EG0010 events0 affected188 at risk
Overdose	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Patella fracture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Post procedural complication	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Procedural headache	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Procedural nausea	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Procedural pain	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Procedural vomiting	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Rib fracture	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0015 events3 affected188 at risk
Road traffic accident	Injury, poisoning and procedural complications	EG0004 events4 affected209 at risk EG0019 events9 affected188 at risk
Spinal fracture	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Sports injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Tendon injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Traumatic lung injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Wound dehiscence	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Arthroscopy	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Blood glucose fluctuation	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Blood glucose increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Blood pressure increased	Investigations	EG0002 events1 affected209 at risk EG0010 events0 affected188 at risk
Bone scan abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Computerised tomogram abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Drug screen positive	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Electrocardiogram abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Foetal heart rate abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Foetal monitoring	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Grip strength decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Haematocrit decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Liver function test abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lymphocyte count decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neurological examination abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Nuclear magnetic resonance imaging abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Spinal X-ray abnormal	Investigations	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Weight decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Weight increased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
X-ray of pelvis and hip abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dehydration	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Gout	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Obesity	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0014 events4 affected188 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0005 events5 affected209 at risk EG0015 events5 affected188 at risk
Bursitis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Exostosis	Musculoskeletal and connective tissue disorders	EG0007 events6 affected209 at risk EG00112 events11 affected188 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG00110 events10 affected188 at risk
Flank pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Groin pain	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	EG0007 events7 affected209 at risk EG00110 events10 affected188 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	EG00012 events11 affected209 at risk EG00120 events18 affected188 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0014 events4 affected188 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Ligament disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0017 events7 affected188 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0011 events1 affected188 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0014 events3 affected188 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG0005 events5 affected209 at risk EG00111 events9 affected188 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Neck pain	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG00110 events10 affected188 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0013 events3 affected188 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG00112 events11 affected188 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG00110 events10 affected188 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	EG0005 events4 affected209 at risk EG0014 events3 affected188 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	EG0006 events6 affected209 at risk EG0016 events4 affected188 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0015 events4 affected188 at risk
Synovitis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	EG0006 events5 affected209 at risk EG00110 events8 affected188 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Burning sensation	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Carotid artery disease	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Carpal tunnel syndrome	Nervous system disorders	EG0003 events3 affected209 at risk EG0013 events3 affected188 at risk
Cerebral atrophy	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cerebral hypoperfusion	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cerebrovascular accident	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cervical cord compression	Nervous system disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Cervical myelopathy	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cervicobrachial syndrome	Nervous system disorders	EG0003 events3 affected209 at risk EG0012 events2 affected188 at risk
Complex regional pain syndrome	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Convulsion	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cubital tunnel syndrome	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dizziness	Nervous system disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Dysarthria	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Headache	Nervous system disorders	EG0006 events5 affected209 at risk EG0015 events5 affected188 at risk
Hemiparesis	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hypoaesthesia	Nervous system disorders	EG0003 events3 affected209 at risk EG0011 events1 affected188 at risk
Intracranial aneurysm	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Intracranial hypotension	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Loss of consciousness	Nervous system disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Lumbar radiculopathy	Nervous system disorders	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Migraine	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nerve root compression	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Neuralgia	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Neuropathy peripheral	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Paraesthesia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Peroneal nerve palsy	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Radicular pain	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Radiculitis brachial	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Radiculopathy	Nervous system disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Sensory loss	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Somnolence	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal claudication	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal cord compression	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Syncope	Nervous system disorders	EG0002 events1 affected209 at risk EG0012 events2 affected188 at risk
Tongue paralysis	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Aggression	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Anxiety	Psychiatric disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Confusional state	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Depression	Psychiatric disorders	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Drug dependence	Psychiatric disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Emotional distress	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Insomnia	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Panic attack	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Suicidal ideation	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Suicide attempt	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Haematuria	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hydronephrosis	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lower urinary tract symptoms	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nephrolithiasis	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Renal artery stenosis	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Stress urinary incontinence	Renal and urinary disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Urinary retention	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Breast pain	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Menorrhagia	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ovarian cyst	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Pelvic pain	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Prostatitis	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Prostatomegaly	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Uterine enlargement	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vaginal discharge	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected209 at risk EG0013 events3 affected188 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nasal septum perforation	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Pleural fibrosis	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Rash	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Telangiectasia	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tobacco user	Social circumstances	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Bunion operation	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Carpal tunnel decompression	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Gastric banding	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hysterectomy	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Knee arthroplasty	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Peripheral nerve decompression	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Prolapse repair	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Rotator cuff repair	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Skin graft	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal decompression	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Spinal fusion surgery	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Vascular stent insertion	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Aortic aneurysm	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Aortic dissection	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Deep vein thrombosis	Vascular disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Femoral artery occlusion	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Haematoma	Vascular disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hypertension	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Intermittent claudication	Vascular disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Peripheral arterial occlusive disease	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Peripheral vascular disorder	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk

Other Adverse Events

Term	Organ System	Statistical Information
Anaemia	Blood and lymphatic system disorders	EG0001 events1 affected209 at risk EG0014 events4 affected188 at risk
Lymphadenopathy	Blood and lymphatic system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Microcytic anaemia	Blood and lymphatic system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Splenomegaly	Blood and lymphatic system disorders	EG0000 events0 affected209 at risk EG0012 events1 affected188 at risk
Arrhythmia	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Atrioventricular block second degree	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Bradycardia	Cardiac disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Bundle branch block left	Cardiac disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Palpitations	Cardiac disorders	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Tachycardia	Cardiac disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Congenital choroid plexus cyst	Congenital, familial and genetic disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spine malformation	Congenital, familial and genetic disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Deafness	Ear and labyrinth disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ear pain	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Eustachian tube dysfunction	Ear and labyrinth disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hypoacusis	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Meniere's disease	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tinnitus	Ear and labyrinth disorders	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Vertigo	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Vertigo positional	Ear and labyrinth disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Adrenal cyst	Endocrine disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Blepharospasm	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cataract	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Conjunctival discolouration	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Conjunctivitis	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Eye swelling	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Eyelid ptosis	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Macular degeneration	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Papilloedema	Eye disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Photophobia	Eye disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Scintillating scotoma	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vision blurred	Eye disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Abdominal discomfort	Gastrointestinal disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Abdominal distension	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Abdominal pain	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Abdominal pain lower	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Abdominal pain upper	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Acquired oesophageal web	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cheilitis	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Colitis	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Colitis ulcerative	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Colonic polyp	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Constipation	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Dental caries	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Diarrhoea	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Diverticulum	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dyspepsia	Gastrointestinal disorders	EG0004 events4 affected209 at risk EG0012 events2 affected188 at risk
Dysphagia	Gastrointestinal disorders	EG0007 events7 affected209 at risk EG00117 events17 affected188 at risk
Eructation	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Functional gastrointestinal disorder	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Gastric haemorrhage	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastric polyps	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastric ulcer	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastritis	Gastrointestinal disorders	EG0003 events3 affected209 at risk EG0012 events2 affected188 at risk
Gastrointestinal pain	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Gastrointestinal sounds abnormal	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	EG0004 events4 affected209 at risk EG0016 events6 affected188 at risk
Haemorrhoids	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Hiatus hernia	Gastrointestinal disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Inguinal hernia	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Intestinal polyp	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Irritable bowel syndrome	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Loose tooth	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nausea	Gastrointestinal disorders	EG00010 events9 affected209 at risk EG0019 events8 affected188 at risk
Odynophagia	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Oesophagitis	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Proctalgia	Gastrointestinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Salivary gland mass	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Tooth erosion	Gastrointestinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vomiting	Gastrointestinal disorders	EG0006 events6 affected209 at risk EG0013 events3 affected188 at risk
Adverse drug reaction	General disorders	EG0007 events7 affected209 at risk EG0015 events5 affected188 at risk
Asthenia	General disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Chest discomfort	General disorders	EG0006 events6 affected209 at risk EG0010 events0 affected188 at risk
Chest pain	General disorders	EG0005 events5 affected209 at risk EG0013 events3 affected188 at risk
Chills	General disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Complication of device insertion	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cyst	General disorders	EG0001 events1 affected209 at risk EG0014 events4 affected188 at risk
Device breakage	General disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Device connection issue	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Device deployment issue	General disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Device dislocation	General disorders	EG0006 events5 affected209 at risk EG0013 events3 affected188 at risk
Face oedema	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Fatigue	General disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Feeling cold	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Gait disturbance	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hernia	General disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Impaired healing	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Local swelling	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Localised oedema	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Malaise	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Medical device complication	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Medical device discomfort	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Oedema	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Oedema peripheral	General disorders	EG0003 events3 affected209 at risk EG0013 events3 affected188 at risk
Pain	General disorders	EG00012 events12 affected209 at risk EG0017 events7 affected188 at risk
Polyp	General disorders	EG0000 events0 affected209 at risk EG0010 events0 affected188 at risk
Pyrexia	General disorders	EG0000 events0 affected209 at risk EG0017 events7 affected188 at risk
Secretion discharge	General disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Sensation of foreign body	General disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Spinal pain	General disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Swelling	General disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tenderness	General disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Biliary dyskinesia	Hepatobiliary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cholecystitis chronic	Hepatobiliary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cholelithiasis	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gallbladder disorder	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Hepatic cyst	Hepatobiliary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Hepatic steatosis	Hepatobiliary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Drug hypersensitivity	Immune system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Hypersensitivity	Immune system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Seasonal allergy	Immune system disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Abscess limb	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Acute sinusitis	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Bacterial infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Bronchiolitis	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Bronchitis	Infections and infestations	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Cellulitis	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Gastroenteritis viral	Infections and infestations	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Gastrointestinal infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Helicobacter infection	Infections and infestations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Herpes zoster	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Influenza	Infections and infestations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Kidney infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Klebsiella infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Lower respiratory tract infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nasopharyngitis	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Onychomycosis	Infections and infestations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Otitis externa	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Pharyngitis streptococcal	Infections and infestations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Pneumonia	Infections and infestations	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Post procedural infection	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Sinusitis	Infections and infestations	EG0005 events5 affected209 at risk EG0014 events4 affected188 at risk
Stitch abscess	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Streptococcal infection	Infections and infestations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tooth abscess	Infections and infestations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Upper respiratory tract infection	Infections and infestations	EG0003 events2 affected209 at risk EG0014 events4 affected188 at risk
Urinary tract infection	Infections and infestations	EG0002 events2 affected209 at risk EG0014 events4 affected188 at risk
Viral upper respiratory tract infection	Infections and infestations	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Accident	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Accident at home	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cartilage injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Concussion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Contusion	Injury, poisoning and procedural complications	EG0002 events1 affected209 at risk EG0012 events1 affected188 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Epicondylitis	Injury, poisoning and procedural complications	EG0004 events4 affected209 at risk EG0015 events5 affected188 at risk
Epidural fibrosis	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Excoriation	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Fall	Injury, poisoning and procedural complications	EG00015 events13 affected209 at risk EG00124 events16 affected188 at risk
Foot fracture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Head injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0015 events5 affected188 at risk
Heat exhaustion	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Inadequate osteointegration	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Incision site complication	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Incision site erythema	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Incision site haematoma	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Incision site hypoaesthesia	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Incision site oedema	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Incision site pain	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Joint dislocation	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Joint injury	Injury, poisoning and procedural complications	EG0007 events7 affected209 at risk EG0016 events6 affected188 at risk
Laceration	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Ligament injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Ligament rupture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ligament sprain	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Limb crushing injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Limb injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Meniscus lesion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Muscle strain	Injury, poisoning and procedural complications	EG0004 events4 affected209 at risk EG0014 events4 affected188 at risk
Neck injury	Injury, poisoning and procedural complications	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Nerve injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Nerve root injury cervical	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nerve root injury lumbar	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Nerve root injury sacral	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Periorbital haemorrhage	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Procedural headache	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Procedural hypertension	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Procedural hypotension	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Procedural nausea	Injury, poisoning and procedural complications	EG0003 events3 affected209 at risk EG0011 events1 affected188 at risk
Procedural pain	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Procedural site reaction	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Procedural vomiting	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Repetitive strain injury	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Rib fracture	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Road traffic accident	Injury, poisoning and procedural complications	EG00013 events13 affected209 at risk EG0019 events8 affected188 at risk
Soft tissue injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Sports injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tendon injury	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Tendon rupture	Injury, poisoning and procedural complications	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ulnar nerve injury	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Urinary retention postoperative	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Wound complication	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Wound dehiscence	Injury, poisoning and procedural complications	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Wound secretion	Injury, poisoning and procedural complications	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Alanine aminotransferase increased	Investigations	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Angiogram cerebral abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Aspartate aminotransferase increased	Investigations	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Bacterial test positive	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Biopsy mucosa normal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Biopsy oesophagus normal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Blood cholesterol increased	Investigations	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Blood cortisol decreased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Blood creatine phosphokinase increased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Blood glucose increased	Investigations	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Blood pressure increased	Investigations	EG0003 events3 affected209 at risk EG0011 events1 affected188 at risk
Blood triglycerides increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Bone scan abnormal	Investigations	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Computerised tomogram abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
False positive investigation result	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Glomerular filtration rate decreased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Glycosylated haemoglobin increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Grip strength decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Haemoglobin decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Heart rate increased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
High density lipoprotein decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lasegue's test positive	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lipids increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Mean cell haemoglobin	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neurological examination	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Neurological examination abnormal	Investigations	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Nuclear magnetic resonance imaging abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Orthopedic examination abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Oxygen saturation decreased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Scan abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Scan bone marrow abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Sensory level abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal X-ray abnormal	Investigations	EG0000 events0 affected209 at risk EG0015 events5 affected188 at risk
Staphylococcus test positive	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Stress echocardiogram abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Urine output decreased	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Weight decreased	Investigations	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Weight increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
White blood cell count increased	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
X-ray abnormal	Investigations	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
X-ray limb abnormal	Investigations	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Decreased appetite	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Dehydration	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Diabetes mellitus	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Fluid overload	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hyperglycaemia	Metabolism and nutrition disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Hypoglycaemia	Metabolism and nutrition disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vitamin C deficiency	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	EG00021 events18 affected209 at risk EG00120 events18 affected188 at risk
Arthritis	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG00037 events34 affected209 at risk EG00139 events35 affected188 at risk
Bone erosion	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Bursa disorder	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Bursitis	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0012 events2 affected188 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Cervical spine flattening	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Coccydynia	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Exostosis	Musculoskeletal and connective tissue disorders	EG00019 events17 affected209 at risk EG00113 events11 affected188 at risk
Facet joint syndrome	Musculoskeletal and connective tissue disorders	EG00011 events10 affected209 at risk EG00110 events10 affected188 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0015 events5 affected188 at risk
Flank pain	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Groin pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	EG00014 events14 affected209 at risk EG00112 events12 affected188 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0013 events2 affected188 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	EG00014 events12 affected209 at risk EG00124 events19 affected188 at risk
Intervertebral disc space narrowing	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Jaw disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Joint crepitation	Musculoskeletal and connective tissue disorders	EG00023 events19 affected209 at risk EG0015 events5 affected188 at risk
Joint lock	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	EG0006 events6 affected209 at risk EG0019 events9 affected188 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Kyphosis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	EG0005 events5 affected209 at risk EG0013 events3 affected188 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0013 events2 affected188 at risk
Muscle atrophy	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	EG00025 events23 affected209 at risk EG00116 events12 affected188 at risk
Muscle tightness	Musculoskeletal and connective tissue disorders	EG00010 events9 affected209 at risk EG0017 events6 affected188 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	EG00015 events14 affected209 at risk EG00110 events8 affected188 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	EG0009 events8 affected209 at risk EG00111 events8 affected188 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	EG00059 events51 affected209 at risk EG00146 events39 affected188 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	EG00018 events16 affected209 at risk EG00114 events14 affected188 at risk
Myalgia	Musculoskeletal and connective tissue disorders	EG00014 events13 affected209 at risk EG0016 events6 affected188 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Myopathy	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neck pain	Musculoskeletal and connective tissue disorders	EG00082 events64 affected209 at risk EG00177 events60 affected188 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	EG0008 events6 affected209 at risk EG00117 events12 affected188 at risk
Osteolysis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	EG00051 events41 affected209 at risk EG00158 events50 affected188 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Patellofemoral pain syndrome	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0010 events0 affected188 at risk
Pelvic deformity	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0018 events8 affected188 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	EG0008 events8 affected209 at risk EG0017 events6 affected188 at risk
Sacroiliitis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Scoliosis	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0010 events0 affected188 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal deformity	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal fusion acquired	Musculoskeletal and connective tissue disorders	EG0006 events6 affected209 at risk EG0010 events0 affected188 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	EG0009 events9 affected209 at risk EG00116 events15 affected188 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	EG0004 events4 affected209 at risk EG0017 events5 affected188 at risk
Spondylolysis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Syndesmophyte	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	EG0002 events2 affected209 at risk EG0012 events2 affected188 at risk
Synovitis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0010 events0 affected188 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0017 events6 affected188 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Trismus	Musculoskeletal and connective tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	EG00013 events10 affected209 at risk EG00112 events12 affected188 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Benign nipple neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neurofibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Pituitary tumour recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Spinal haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0003 events3 affected209 at risk EG0011 events1 affected188 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 events1 affected209 at risk EG0012 events2 affected188 at risk
Amnesia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Aphonia	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Areflexia	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Ataxia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Aura	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Balance disorder	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Benign intracranial hypertension	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Brachial plexopathy	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Burning sensation	Nervous system disorders	EG0006 events6 affected209 at risk EG0013 events3 affected188 at risk
Carotid artery disease	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Carpal tunnel syndrome	Nervous system disorders	EG00011 events11 affected209 at risk EG00111 events10 affected188 at risk
Cerebral infarction	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events1 affected188 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	EG0002 events1 affected209 at risk EG0011 events1 affected188 at risk
Cervical cord compression	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cervicobrachial syndrome	Nervous system disorders	EG0003 events3 affected209 at risk EG0015 events3 affected188 at risk
Cervicogenic headache	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cognitive disorder	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Complex regional pain syndrome	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Convulsion	Nervous system disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Cubital tunnel syndrome	Nervous system disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Demyelination	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Diabetic neuropathy	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Dizziness	Nervous system disorders	EG0003 events3 affected209 at risk EG0013 events2 affected188 at risk
Dizziness postural	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dysaesthesia	Nervous system disorders	EG0002 events2 affected209 at risk EG0015 events4 affected188 at risk
Dyskinesia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Epilepsy	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Extensor plantar response	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Gait spastic	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Head discomfort	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Head titubation	Nervous system disorders	EG0000 events0 affected209 at risk EG0010 events0 affected188 at risk
Headache	Nervous system disorders	EG00033 events31 affected209 at risk EG00144 events35 affected188 at risk
Hemiparesis	Nervous system disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Hyperaesthesia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hyperreflexia	Nervous system disorders	EG0000 events0 affected209 at risk EG0015 events5 affected188 at risk
Hypoaesthesia	Nervous system disorders	EG00055 events42 affected209 at risk EG00147 events38 affected188 at risk
Hyporeflexia	Nervous system disorders	EG0001 events1 affected209 at risk EG0015 events4 affected188 at risk
Loss of consciousness	Nervous system disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Lumbar radiculopathy	Nervous system disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Migraine	Nervous system disorders	EG0002 events2 affected209 at risk EG0016 events6 affected188 at risk
Muscle contractions involuntary	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Myelopathy	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Nerve compression	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Nerve root compression	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nerve root lesion	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neuritis	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Neurological decompensation	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Neuropathy peripheral	Nervous system disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Occipital neuralgia	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Paraesthesia	Nervous system disorders	EG00042 events33 affected209 at risk EG00117 events16 affected188 at risk
Periodic limb movement disorder	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Radial nerve compression	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Radicular pain	Nervous system disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Radicular syndrome	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Radiculitis	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Radiculitis lumbosacral	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Radiculopathy	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Restless legs syndrome	Nervous system disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Sciatica	Nervous system disorders	EG0001 events1 affected209 at risk EG0013 events3 affected188 at risk
Sensory disturbance	Nervous system disorders	EG0004 events3 affected209 at risk EG0012 events2 affected188 at risk
Sensory loss	Nervous system disorders	EG0006 events6 affected209 at risk EG0016 events6 affected188 at risk
Somnolence	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Syncope	Nervous system disorders	EG0005 events3 affected209 at risk EG0010 events0 affected188 at risk
Syringomyelia	Nervous system disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Tinel's sign	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Transient ischaemic attack	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tremor	Nervous system disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Vocal cord paralysis	Nervous system disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Vocal cord paresis	Nervous system disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Affective disorder	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Anxiety	Psychiatric disorders	EG0003 events3 affected209 at risk EG0013 events3 affected188 at risk
Anxiety disorder	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Depression	Psychiatric disorders	EG0004 events4 affected209 at risk EG0014 events4 affected188 at risk
Disorientation	Psychiatric disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Drug dependence	Psychiatric disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Emotional distress	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hallucination	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Initial insomnia	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Insomnia	Psychiatric disorders	EG0007 events6 affected209 at risk EG0011 events1 affected188 at risk
Mental status changes	Psychiatric disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Panic attack	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Post-traumatic stress disorder	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Psychosomatic disease	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Psychotic disorder	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Somatoform disorder	Psychiatric disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Stress	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Tension	Psychiatric disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Bladder dysfunction	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Calculus bladder	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Cystitis interstitial	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Dysuria	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Haematuria	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Micturition urgency	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nephrolithiasis	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pollakiuria	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Renal cyst	Renal and urinary disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Renal disorder	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Renal failure chronic	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Urethral stenosis	Renal and urinary disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Urinary retention	Renal and urinary disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Breast cyst	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Breast discharge	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Breast fibrosis	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Breast mass	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Breast pain	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Breast tenderness	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Cervical dysplasia	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Endometriosis	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Menopausal symptoms	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Menorrhagia	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Menstrual disorder	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ovarian cyst	Reproductive system and breast disorders	EG0002 events2 affected209 at risk EG0013 events3 affected188 at risk
Ovarian mass	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Prostatomegaly	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Testicular pain	Reproductive system and breast disorders	EG0002 events1 affected209 at risk EG0010 events0 affected188 at risk
Varicocele	Reproductive system and breast disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Vulvovaginal burning sensation	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Vulvovaginal pruritus	Reproductive system and breast disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Apnoeic attack	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected209 at risk EG0014 events3 affected188 at risk
Cough	Respiratory, thoracic and mediastinal disorders	EG00010 events9 affected209 at risk EG0012 events2 affected188 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected209 at risk EG0015 events5 affected188 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected209 at risk EG0013 events3 affected188 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	EG0004 events4 affected209 at risk EG0016 events5 affected188 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Pharyngeal mass	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Reflux laryngitis	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected209 at risk EG0011 events1 affected188 at risk
Rhinitis seasonal	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0016 events5 affected188 at risk
Snoring	Respiratory, thoracic and mediastinal disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	EG0001 events1 affected209 at risk EG0012 events2 affected188 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Acne	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Blister	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	EG0002 events2 affected209 at risk EG0010 events0 affected188 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	EG0003 events3 affected209 at risk EG0010 events0 affected188 at risk
Erythema	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0013 events3 affected188 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0013 events1 affected188 at risk
Ingrown hair	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Lentigo	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Pruritus	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0011 events1 affected188 at risk
Psoriasis	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Rash	Skin and subcutaneous tissue disorders	EG0007 events5 affected209 at risk EG0016 events5 affected188 at risk
Scar	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Sebaceous gland disorder	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Skin lesion	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Skin reaction	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Swelling face	Skin and subcutaneous tissue disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Urticaria	Skin and subcutaneous tissue disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Canalith repositioning procedure	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Colon polypectomy	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0010 events0 affected188 at risk
Sinus operation	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Tooth extraction	Surgical and medical procedures	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Urostomy	Surgical and medical procedures	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Haematoma	Vascular disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Haemorrhage	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Hot flush	Vascular disorders	EG0000 events0 affected209 at risk EG0012 events1 affected188 at risk
Hypertension	Vascular disorders	EG0007 events7 affected209 at risk EG0015 events5 affected188 at risk
Lymphoedema	Vascular disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Orthostatic hypotension	Vascular disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk
Peripheral coldness	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Varicose vein	Vascular disorders	EG0000 events0 affected209 at risk EG0012 events2 affected188 at risk
Vasodilatation	Vascular disorders	EG0000 events0 affected209 at risk EG0011 events1 affected188 at risk
Venous insufficiency	Vascular disorders	EG0001 events1 affected209 at risk EG0010 events0 affected188 at risk

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D002493	Central Nervous System Diseases

ID	Term
D059145	Total Disc Replacement
D001860	Bone Plates

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures
D019919	Prosthesis Implantation
D016268	Internal Fixators
D019736	Prostheses and Implants
D004864	Equipment and Supplies
D009984	Orthopedic Fixation Devices
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D053831	Surgical Fixation Devices

ID	Title	Description
BG000	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.
BG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.
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	PRESTIGE LP Device	PRESTIGE LP device at two adjacent levels: PRESTIGE LP is a prosthetic device intended to replace a damaged disc in the cervical spine and intended to act as an intervertebral body spacer rather than a fusion device. It is inserted using an anterior surgical approach.			72	209	191	209
EG001	ATLANTIS Cervical Plate System	Bi-level fusion with ATLANTIS Cervical Plate System: Bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS Cervical Plate System.			90	188	171	188