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The purpose of this study is to determine whether recombinant human platelet-derived growth factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis elbow).
Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study
Study Center(s): 6
Number of Subjects: 100
Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age
Study Drug, Dose, Regimen:
Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB
Duration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB)
Duration of Follow-up: 24 weeks (6 months) post-operative follow-up
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control | Placebo Comparator | Dose A - sodium acetate buffer (0 mg rhPDGF-BB) |
|
| 0.45 mg rhPDGF-BB | Experimental | Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB |
|
| 0.75 mg rhPDGF-BB | Experimental | Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB |
|
| 1.5 mg rhPDGF-BB | Experimental | Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB |
|
| 3.0 mg rhPDGF-BB | Experimental | Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhPDGF-BB Injection | Drug | Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| Measure | Description | Time Frame |
|---|---|---|
| Elbow Pain Assessments (VAS), Treated Subjects | Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). | Baseline, 2, 4, 8, 12, and 24 weeks |
| Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. | Baseline, 4, 8, 12, and 24 weeks |
| Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally | Baseline, 4, 8, 12, and 24 weeks |
| Grip Strength Test, All Treated Subjects | Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. |
Not provided
Not provided
Inclusion Criteria:
Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form specific to this study prior to enrollment
Subject has a clinical diagnosis of lateral epicondylitis
Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion
Subject's symptoms have persisted for at least 3 months despite conservative treatment that includes one or combinations of:
Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits
Subject is 21-80 years of age and considered to be skeletally mature
Exclusion Criteria:
Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment
Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow
Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study
Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage >10mg/day)
Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis
Subject has a positive medical history of any of the following:
Subject currently has an acute infection at the injection site
Subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed rhPDGF-BB Injection treatment site
Subject is physically or mentally compromised (e.g. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
Subject has an allergy to yeast-derived products
Subject has received an investigational therapy or approved therapy for investigational use within 30 days of injection procedure or during the follow-up phase of this study
Subject is a prisoner, or is known or suspected to be transient
Subject's condition represents a worker's compensation case
Subject is currently involved in a health-related litigation procedure
Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry
Subject is pregnant, or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
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| Name | Affiliation | Role |
|---|---|---|
| Edward Akelman, MD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Tucson Orthopaedic Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Control | Dose A - sodium acetate buffer (0 mg rhPDGF-BB) rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| FG001 | 0.45 mg rhPDGF-BB | Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| FG002 | 0.75 mg rhPDGF-BB | Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| FG003 | 1.5 mg rhPDGF-BB | Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| FG004 | 3.0 mg rhPDGF-BB | Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Control | Dose A - sodium acetate buffer (0 mg rhPDGF-BB) rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| BG001 | 0.45 mg rhPDGF-BB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Elbow Pain Assessments (VAS), Treated Subjects | Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). | Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 2, 4, 8, 12, and 24 weeks |
|
Patients were assessed through study completion scheduled at 24 weeks following surgery.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Control | Dose A - sodium acetate buffer (0 mg rhPDGF-BB) Placebo: sodium acetate buffer (0 mg rhPDGF-BB) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site calcification | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lacrimation increased | Eye disorders | Systematic Assessment |
While this preliminary study suggests similar safety profiles for PDGF and placebo, future studies with larger sample sizes, possibly different concentrations, and tighter inclusion criteria are needed to definitely assess the effectiveness of PDGF.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Justin Moss | Wright Medical | 615-236-4984 | justin.moss@wright.com |
Not provided
| ID | Term |
|---|---|
| D013716 | Tennis Elbow |
| ID | Term |
|---|---|
| D000070639 | Elbow Tendinopathy |
| D052256 | Tendinopathy |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077214 | Becaplermin |
| ID | Term |
|---|---|
| D020574 | Proto-Oncogene Proteins c-sis |
| D010982 | Platelet-Derived Growth Factor |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
Not provided
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Not provided
Not provided
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| Placebo | Drug | sodium acetate buffer (0 mg rhPDGF-BB) |
|
| Baseline, 4, 8, 12, and 24 weeks |
| Maximum Grip Strength, Treated Subjects | A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. | Baseline, 4, 8, 12, and 24 weeks |
| Tucson |
| Arizona |
| 85712 |
| United States |
| NEA Baptist Clinic | Jonesboro | Arkansas | 72401 | United States |
| Coastal Orthopedics & Sports Medicine | Bradenton | Florida | 34209 | United States |
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33637 | United States |
| OrthoCarolina | Charlotte | North Carolina | 28207 | United States |
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| BG002 | 0.75 mg rhPDGF-BB | Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| BG003 | 1.5 mg rhPDGF-BB | Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| BG004 | 3.0 mg rhPDGF-BB | Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
| OG002 | 0.75 mg rhPDGF-BB | Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| OG003 | 1.5 mg rhPDGF-BB | Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
| OG004 | 3.0 mg rhPDGF-BB | Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection |
|
|
| Primary | Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects | The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. | Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4, 8, 12, and 24 weeks |
|
|
|
| Primary | Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects | The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales:
In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally | Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4, 8, 12, and 24 weeks |
|
|
|
| Primary | Grip Strength Test, All Treated Subjects | Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. | Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points. | Posted | Mean | Standard Deviation | lbs. | Baseline, 4, 8, 12, and 24 weeks |
|
|
|
| Primary | Maximum Grip Strength, Treated Subjects | A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis. | Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points. | Posted | Mean | Standard Deviation | lbs. | Baseline, 4, 8, 12, and 24 weeks |
|
|
|
| 0 |
| 20 |
| 15 |
| 20 |
| EG001 | 0.45 mg rhPDGF-BB | Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 0 | 20 | 20 | 20 |
| EG002 | 0.75 mg rhPDGF-BB | Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 2 | 20 | 18 | 20 |
| EG003 | 1.5 mg rhPDGF-BB | Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 0 | 20 | 16 | 20 |
| EG004 | 3.0 mg rhPDGF-BB | Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB rhPDGF-BB Injection: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection | 1 | 20 | 18 | 20 |
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Feeling hot | General disorders | Systematic Assessment |
|
| Injection site calcification | General disorders | Systematic Assessment |
|
| Injection site coldness | General disorders | Systematic Assessment |
|
| Injection site discolouration | General disorders | Systematic Assessment |
|
| Injection site discomfort | General disorders | Systematic Assessment |
|
| Injection site erythema | General disorders | Systematic Assessment |
|
| Injection site haematoma | General disorders | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | Systematic Assessment |
|
| Injection site inflammation | General disorders | Systematic Assessment |
|
| Injection site mass | General disorders | Systematic Assessment |
|
| Injection site pain | General disorders | Systematic Assessment |
|
| Injection site pruritus | General disorders | Systematic Assessment |
|
| Injection site rash | General disorders | Systematic Assessment |
|
| Injection site swelling | General disorders | Systematic Assessment |
|
| Injection site warmth | General disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Tenderness | General disorders | Systematic Assessment |
|
| Biliary dyskinesia | Hepatobiliary disorders | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
|
| Eyelid infection | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Otitis media | Infections and infestations | Systematic Assessment |
|
| Parotitis | Infections and infestations | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Tooth infection | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Conjunctival abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Traumatic lung injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Renal function test abnormal | Investigations | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint crepitation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Joint warmth | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Systematic Assessment |
|
| Presyncope | Nervous system disorders | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | Systematic Assessment |
|
| Tremor | Nervous system disorders | Systematic Assessment |
|
| Adjustment disorder with anxiety | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Microalbuminuria | Renal and urinary disorders | Systematic Assessment |
|
| Breast tenderness | Reproductive system and breast disorders | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pigmentation disorder | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Female sterilisation | Surgical and medical procedures | Systematic Assessment |
|
| Uterine dilation and curettage | Surgical and medical procedures | Systematic Assessment |
|
Not provided
Not provided
| D000092464 |
| Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004268 | DNA-Binding Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
|
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