A Study of the Safety and Efficacy of Hylan G-F 20 (Synvi... | NCT00131352

NCT00131352

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Synvisc	Experimental	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc).	Device: hylan G-F 20
Saline Control	Placebo Comparator	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.	Other: Phosphate Buffered Saline

Name	Type	Description	Arm Group Labels	Other Names
hylan G-F 20	Device	Single injection of 6 mL of hylan G-F 20 (Synvisc).	Synvisc

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale	The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.	Day 0, up to week 26

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale	The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.	Day 0, Week 26

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Monitor	Genzyme, a Sanofi Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Erasme		Brussels		1070	Belgium
Universitair Ziekenhuis Gent

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19304567	Derived	Chevalier X, Jerosch J, Goupille P, van Dijk N, Luyten FP, Scott DL, Bailleul F, Pavelka K. Single, intra-articular treatment with 6 ml hylan G-F 20 in patients with symptomatic primary osteoarthritis of the knee: a randomised, multicentre, double-blind, placebo controlled trial. Ann Rheum Dis. 2010 Jan;69(1):113-9. doi: 10.1136/ard.2008.094623.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG000123 subjectsSafety population

FG001130 subjectsSafety population

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
BG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00063.6± 9.64 BG00162.5± 9.17 BG00263.0± 9.40

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00092 BG00188 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG000118 BG001125 BG002

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

Change From Baseline in Knee Pain Over the Course of the 26-week Initial Treatment Period As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale

The change from baseline over the course of the 26-week initial treatment period using participants' assessment of pain. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.

Intent-To-Treat (ITT) population which included all participants randomized to study treatment on Day 0.

Posted

Mean

Standard Error

units on a scale

Day 0, up to week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants	OG000124 OG001129

Title

Denominators

Categories

Title	Measurements
	OG000-0.84± 0.060 OG001-0.69± 0.058

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		ANCOVA	The repeated measures ANCOVA model included terms for treatment, site, time and time-by-treatment interaction; the baseline score was a covariate.	0.047							95						No	Superiority or Other

Secondary

Change From Baseline in Knee Pain at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A (Pain) Subscale

The change from baseline to week 26 using participants' assessment of pain. The WOMAC Pain Subscale has a score range of 0-4, where 0=no pain and 4=extreme pain.

Intent-To-Treat (ITT) population.

Posted

Mean

Standard Error

units on a scale

Day 0, Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants	OG000

Secondary

Participants Level of Pain While Walking at Week 26 As Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale Version 3.1 (WOMAC LK 3.1) A1 (Walking Pain) Subscale

Participants categorized the pain they felt while walking using the WOMAC LK 3.1) A1 (Walking Pain) Subscale. The scale rates pain as none, mild, moderate, severe and extreme.

Intent-To-Treat (ITT) population

Posted

Number

participants

Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants	OG000

Secondary

Change From Baseline Over the Course of the 26-week Initial Treatment Period in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale

The change from baseline over the course of the 26-week initial treatment period using participants' assessment of physical function. Mean scores were used for baseline (day 0) and for all visits up to week 26 (weeks 4, 8, 12, 18 and 26). The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.

Intent-To-Treat (ITT) population.

Posted

Mean

Standard Error

units on a scale

Day 0, up to week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts

Secondary

Change From Baseline at Week 26 in Physical Function Measured by Participants Using the Western Ontario and McMaster Universities Osteoarthritis Index Likert Scale (WOMAC LK Version 3.1) C (Function) Subscale

The change from baseline to week 26 using participants' assessment of physical function. The WOMAC Function Subscale has a score range of 0-4 to assess the degree of difficulty completing tasks within the past 48 hours, where 0=no difficulty and 4=extreme difficulty.

Intent-To-Treat (ITT) population.

Posted

Mean

Standard Error

units on a scale

Day 0, Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants

Secondary

Participant Global Assessment (PTGA) of the Target Knee Osteoarthritis Condition at Week 26

The Participant Global Assessment (PTGA) was used by participants to rate their osteoarthritis (OA). PTGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.

Intent-To-Treat (ITT) population

Posted

Number

participants

Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants	OG000

Secondary

Clinical Observer Global Assessment (COGA) of the Target Knee Osteoarthritis (OA) Condition at Week 26

The Blinded Clinical Observer gave a global assessment (COGA) of the target knee OA. COGA uses 5 scoring levels: Very well=0, Well=1, Fair=2, Poor=3, Very poor=4.

Intent-To-Treat (ITT) population

Posted

Number

participants

Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units	Counts
Participants	OG000

Secondary

Participants Classified as Responders Per the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Criteria at Week 26

Participants were classified as a positive responder if at least one of the following two conditions were met:

A significant improvement in either the pain (WOMAC A) or physical function (WOMAC C) subscales, defined as both a ≥ 50% improvement from Baseline and an absolute change from Baseline of ≥ 20 normalised units (NU), OR
Improvement in at least 2 of 3 subscales - pain (WOMAC A), physical function (WOMAC C) or Participant Global Assessment (PTGA). Improvement for all three scales is defined as ≥ 20% improvement from Baseline and an absolute change from Baseline of ≥ 10 NU

Intent-To-Treat (ITT) population.

Posted

Number

participants

Week 26

ID	Title	Description
OG000	Synvisc	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
OG001	Saline Control	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.

Units

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Synvisc - Initial Treatment Period	Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).	5	123	70	123
EG001	Saline Control - Initial Treatment Period	Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.	3	130	77	130
EG002	Synvisc - Repeat Treatment Period	Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).	0	77	9	77
EG003	Synvisc (From Saline Control) - Repeat Treatment Period	Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).	2	83	11	83

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG0030 affected83 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Sinus arrest	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Hernia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Radial nerve palsy	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG0030 affected83 at risk
Sinus arrhythmia	Cardiac disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0012 affected130 at risk EG0020 affected77 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Gait disturbance	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Hernia	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0021 affected77 at risk EG003
Influenza like illness	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Injection site haematoma	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0021 affected77 at risk EG003
Injection site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0011 affected130 at risk EG0021 affected77 at risk EG003
Malaise	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Oedema peripheral	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0012 affected130 at risk EG0020 affected77 at risk EG003
Pyrexia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Bronchitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0013 affected130 at risk EG0022 affected77 at risk EG003
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Cystitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Dental caries	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Erysipelas	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Herpes zoster ophthalmic	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Infected insect bite	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Influenza	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0004 affected123 at risk EG0017 affected130 at risk EG0020 affected77 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Mastitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0005 affected123 at risk EG0017 affected130 at risk EG0020 affected77 at risk EG003
Oral fungal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Pharyngitis bacterial	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Sinusitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Viral infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0003 affected123 at risk EG0013 affected130 at risk EG0020 affected77 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Heart rate increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Helicobacter pylori identification test positive	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00032 affected123 at risk EG00130 affected130 at risk EG0024 affected77 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0021 affected77 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0008 affected123 at risk EG00110 affected130 at risk EG0020 affected77 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0021 affected77 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0007 affected123 at risk EG0017 affected130 at risk EG0020 affected77 at risk EG003
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG00010 affected123 at risk EG00113 affected130 at risk EG0021 affected77 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0005 affected123 at risk EG0017 affected130 at risk EG0020 affected77 at risk EG003
Joint warmth	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0015 affected130 at risk EG0020 affected77 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0013 affected130 at risk EG0020 affected77 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0013 affected130 at risk EG0020 affected77 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0013 affected130 at risk EG0020 affected77 at risk EG003
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0004 affected123 at risk EG0012 affected130 at risk EG0020 affected77 at risk EG003
Spinal disorder	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0012 affected130 at risk EG0020 affected77 at risk EG003
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Cervical root pain	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Dizziness	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Headache	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0009 affected123 at risk EG00115 affected130 at risk EG0020 affected77 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Migraine	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Nerve compression	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Sciatica	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Syncope vasovagal	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Depression	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Panic attack	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Stress	Psychiatric disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0000 affected123 at risk EG0011 affected130 at risk EG0020 affected77 at risk EG003
Hypertension	Vascular disorders	MedDRA 13.0	Systematic Assessment	EG0002 affected123 at risk EG0010 affected130 at risk EG0020 affected77 at risk EG003

ID	Term
D020370	Osteoarthritis, Knee
D009140	Musculoskeletal Diseases

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D012216	Rheumatic Diseases