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| ID | Type | Description | Link |
|---|---|---|---|
| CXI01CX000954-01A1 | Other Identifier | eRA project Reference |
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The purpose of this exploratory trial is to investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
Osteoarthritis (OA), the most common form of arthritis, is a prevalent and debilitating disease without therapies that alter disease progress and is currently managed with symptom-modifying therapies that are only modestly effective. In spite of substantial progress in understanding the pathogenesis of OA, no effective disease modifying interventions have been established. Degenerative joint cartilage is a central feature of OA, yet joint cartilage has a limited capacity for repair. Results from animal research demonstrate that pulsed low intensity ultrasound (PLIUS) mechanically stimulates, and may promote, cartilage repair. This exploratory trial will investigate whether PLIUS is potentially effective as a disease and symptom modifying intervention in patients with early knee OA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham | Sham Comparator | Treatment to index knee with sham device for 48 weeks |
|
| PLIUS | Experimental | Treatment to index knee with PLIUS device for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Low Intensity Ultrasound | Device | 20 minutes daily for 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness | Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale; b) an improvement in function of at least 20 percent and a decrease of at least 10 mm on the visual-analogue scale; c) an increase in the patient's global assessment score by at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale | 48 weeks |
| Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease | The study has been designed to determine if PLIUS potentially diminishes articular cartilage thinning by measuring cartilage thickness in the tibial femoral joint. The measure selected to best evaluate this is cartilage thickness of the central medial femoral condyle because studies of the OAI (Osteoarthritis Initiative) data have shown this region to be among those most sensitive to change and, due to the anatomical positioning of the device, the most likely to be affected by treatment. | Baseline, 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in WOMAC Stiffness Subscale Score | The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 200. The higher the score, the worse the symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel O Clegg, MD | VA Salt Lake City Health Care System, Salt Lake City, UT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161 | United States | ||
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35258579 | Derived | Sawitzke AD, Jackson CG, Carlson K, Bizien MD, Leiner M, Reda DJ, Sindowski T, Hanrahan C, Spencer RG, Kwoh CK, Lee SJ, Hose K, Robin L, Cain DW, Taylor MD, Bangerter N, Finco M, Clegg DO. Effect of Pulsed Low-Intensity Ultrasonography on Symptom Relief and Tibiofemoral Articular Cartilage Thickness Among Veterans Affairs Enrollees With Knee Osteoarthritis: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e220632. doi: 10.1001/jamanetworkopen.2022.0632. |
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140 participants began, and 136 completed, the 4-Week Sham Run-in Period. 4 of the 140 Sham Run-in participants were withdrawn due to being less than 80% treatment compliance.
Participants were recruited at 2 medical centers between May 2015 and January 2019. The first participant was enrolled May 2017 and the last participant was enrolled in January 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham | Treatment to index knee with sham device for 48 weeks ShamComparator: 20 minutes daily for 48 weeks |
| FG001 | PLIUS (Pulsed Low Intensity UltraSound) | Treatment to index knee with PLIUS device for 48 weeks PLIUS device: 20 minutes daily for 48 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sham Run-in Period |
|
| ||||||||||||||||||
| Sham-Controlled Treatment Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham | Treatment to index knee with sham device for 48 weeks Sham Comparator: 20 minutes daily for 48 weeks |
| BG001 | PLIUS | Treatment to index knee with PLIUS device for 48 weeks Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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 | Co-Primary Measure: a) Symptom Reduction: OMERACT-OARSI Treatment Responsiveness | Outcome Measures in Rheumatology Clinical Trials- Osteoarthritis Research Society International (OMERACT-OARSI) Response incorporates changes in pain and global assessment to define response in OA clinical trials. A response is classified as: 1) An improvement in either pain or function of at least 50 percent accompanied by an absolute decrease of at least 20 mm on the visual-analogue scale for pain or function, OR 2) The occurrence of at least two of the following: a) a decrease in pain of at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale; b) an improvement in function of at least 20 percent and a decrease of at least 10 mm on the visual-analogue scale; c) an increase in the patient's global assessment score by at least 20 percent accompanied by a decrease of at least 10 mm on the visual-analogue scale | Participants with baseline and 48 week values. | Posted | Count of Participants | Participants | No | 48 weeks |
|
Through study completion, an average of 48 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham | Treatment to index knee with sham device for 48 weeks Sham Comparator: 20 minutes daily for 48 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Clegg, MD | VA Salt Lake City Health Care System | 801-582-1565 | daniel.clegg@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2018 | Jun 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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Participants in this double-blind, randomized, sham-controlled trial will be randomly assigned to receive either sham or PLIUS device for 48 weeks.
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| Sham Comparator |
| Device |
20 minutes daily for 48 weeks |
|
| Baseline, week 24, week 48 |
| Change From Baseline in WOMAC Pain Subscale Score | The WOMAC® Index questionnaire [33] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. WOMAC pain scores from 0-500 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in WOMAC Functional Limits Subscale Score | The WOMAC® Index questionnaire [33] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 1700. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Total WOMAC Score | The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 2400. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Patient Global Assessment of Disease Status | A patient global assessment of disease status on a Visual Analog Scale (VAS) will be measured at each clinic visit. Patients will be asked to quantify their disease status on a 100 mm VAS as follows: "Considering all the ways your arthritis of the knee affects you, mark 'X' on the scale for how well you are doing." The scale shows the left hand marker "Very Well", and the right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Investigator Global Assessment of Disease Status | An investigator global assessment of disease status on a 100 mm VAS was measured at each clinic visit as follows: "Make a global assessment of the patient's disease status, with regard to the index knee, by marking an 'X' on the scale below.", with left hand marker "Very Well" and right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered. Study participants are asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants responded to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Baseline, week 24, week 48 |
| Number of Participants Discontinuing the Study Device Due to an Adverse Device Event | Difference between study groups in number of participants who discontinued usage of the study device due to adverse device events at 4, 8, 12, 24, 36, and 48-week visits. | Baseline, 4, 8, 12, 24, 36, and 48-week visits |
| Dallas |
| Texas |
| 75216 |
| United States |
| VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | 84148 | United States |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Body Mass Index | Needed data for baseline measure only available for 130 participants | Mean | Standard Deviation | kg/m^2 |
|
| Years with Osteoarthritis | Participant reported duration of osteoarthritis | Mean | Standard Deviation | years |
|
| ARA Functional Class | American Rheumatism Association (ARA) Functional Class categorize global functional capacity and is assessed by a qualified health professional. A higher class indicates a worsening of functional capacity. Class I - Completely able to perform usual activities of daily living. Class II - Able to perform usual self-care and vocational activities but limited in avocational activities. Class III - Able to perform usual self-care activities but limited in vocational and avocational activities. Class IV - Limited in ability to perform usual self-care, vocational, and avocational activities. | Count of Participants | Participants |
|
| OG000 |
| Sham |
Treatment to index knee with sham device for 48 weeks Sham Comparator: 20 minutes daily for 48 weeks |
| OG001 | PLIUS | Treatment to index knee with PLIUS device for 48 weeks Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks |
|
|
|
| Primary | Co-Primary Measure: b) Disease Modification as Measured by Change From Baseline in Cartilage Thickness of the Central Medial Femoral Condyle Disease | The study has been designed to determine if PLIUS potentially diminishes articular cartilage thinning by measuring cartilage thickness in the tibial femoral joint. The measure selected to best evaluate this is cartilage thickness of the central medial femoral condyle because studies of the OAI (Osteoarthritis Initiative) data have shown this region to be among those most sensitive to change and, due to the anatomical positioning of the device, the most likely to be affected by treatment. | Participants with baseline and 48 week value | Posted | Mean | Standard Deviation | μm | Baseline, 48 weeks |
|
|
|
|
| Secondary | Change From Baseline in WOMAC Stiffness Subscale Score | The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 200. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in WOMAC Pain Subscale Score | The WOMAC® Index questionnaire [33] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. WOMAC pain scores from 0-500 mm. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale mm | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in WOMAC Functional Limits Subscale Score | The WOMAC® Index questionnaire [33] is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 1700. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Total WOMAC Score | The WOMAC® Index questionnaire is a tri-dimensional, disease-specific, self-administered, health status measure. It probes clinically important, patient-relevant symptoms in the areas of pain, stiffness and physical function in patients with osteoarthritis of the hip and/or knee. The WOMAC has been linguistically validated and is a reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments. Range is from 0 - 2400. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Patient Global Assessment of Disease Status | A patient global assessment of disease status on a Visual Analog Scale (VAS) will be measured at each clinic visit. Patients will be asked to quantify their disease status on a 100 mm VAS as follows: "Considering all the ways your arthritis of the knee affects you, mark 'X' on the scale for how well you are doing." The scale shows the left hand marker "Very Well", and the right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Investigator Global Assessment of Disease Status | An investigator global assessment of disease status on a 100 mm VAS was measured at each clinic visit as follows: "Make a global assessment of the patient's disease status, with regard to the index knee, by marking an 'X' on the scale below.", with left hand marker "Very Well" and right hand marker "Very Poor." Range 0 to 100 mm. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Constant Pain Subscale | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered. Study participants are asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants responded to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Intent To Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Intermittent Pain Subscale | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Intent To Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Change From Baseline in Intermittent and Constant Osteoarthritis Pain (ICOAP) Total Pain Score | This 11-item tool is designed to assess pain in individuals with knee osteoarthritis taking into account both constant and intermittent pain experiences. This tool is designed to be interviewer-administered and takes less than 10 minutes to complete. Study participants will be asked to respond to the questionnaire items based on index knee in the past week (i.e., past 7-day period). Study participants will respond to all questions for the same joint. This tool is intended to be responsive to change in OA pain over time or with treatment. Range 0 to 100 mm. The higher the score, the worse the symptoms. | Intent to Treat | Posted | Least Squares Mean | 95% Confidence Interval | Visual Analog Scale (mm) | Baseline, week 24, week 48 |
|
|
|
| Secondary | Number of Participants Discontinuing the Study Device Due to an Adverse Device Event | Difference between study groups in number of participants who discontinued usage of the study device due to adverse device events at 4, 8, 12, 24, 36, and 48-week visits. | Intent to Treat | Posted | Number | participants | Baseline, 4, 8, 12, 24, 36, and 48-week visits |
|
|
|
| 1 |
| 65 |
| 13 |
| 65 |
| 0 |
| 65 |
| EG001 | PLIUS | Treatment to index knee with PLIUS device for 48 weeks Pulsed Low Intensity Ultrasound: 20 minutes daily for 48 weeks | 0 | 67 | 19 | 67 | 0 | 67 |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
|
| Angina, Unstable | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Ascitis | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Atrioventricular block, complete | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dural arteriovenous fistula | Vascular disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Lipoma | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Lumbar radiculopathy | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
|
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pharyngo-oesophageal diverticulum | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Prostatectomy | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Prostatitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Shoulder arthroplasty | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Spinal laminectomy | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MedDRA (20.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Since the ranking and selection procedures are fundamentally different from traditional hypothesis testing, concepts of statistical significance and power have no direct analogue. |