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This was a study to estimate the proportion of participants with osteoarthritis of the knee(s) who were treated with oral or topical analgesics for their symptoms, who did and did not report adequate pain relief at Baseline and to characterize their pain level over a 12-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Enrolled Participants | All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care for treatment of osteoarthritis (OA) of knee(s) | Drug | All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline | Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable). | Baseline (Day 1) |
| Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 | Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable). | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1) | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who are presently receiving prescribed oral or topical analgesics which commenced at least two weeks prior to enrollment
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25150513 | Result | Conaghan PG, Peloso PM, Everett SV, Rajagopalan S, Black CM, Mavros P, Arden NK, Phillips CJ, Rannou F, van de Laar MA, Moore RA, Taylor SD. Inadequate pain relief and large functional loss among patients with knee osteoarthritis: evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies. Rheumatology (Oxford). 2015 Feb;54(2):270-7. doi: 10.1093/rheumatology/keu332. Epub 2014 Aug 23. |
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The study was conducted in 54 trial centers: 18 in France; 4 in Italy; 5 in The Netherlands; 5 in Portugal; and 9 in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | The population consisted of all enrolled participants with adequate and inadequate pain relief. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Adequate Pain Relief | Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline. |
| BG001 | Participants With Inadequate Pain Relief |
| 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 | Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Baseline | Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain due to osteoarthritis in the affected knee in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable). | The population consisted of all participants for which a BPI value was available at baseline. | Posted | Number | Percentage of Participants | Baseline (Day 1) |
|
Up to Month 12
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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 | Participants With Adequate Pain Relief | Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Late Stage Group Development Leader | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Baseline (Day 1) |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | Month 1 |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | Month 3 |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | Month 6 |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | Month 9 |
| Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | Month 12 |
| Site closure |
|
Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| All Enrolled Participants |
All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee. |
|
|
| Primary | Percentage of Participants Who Reported Adequate vs. Inadequate Pain Relief at Month 12 | Participant pain at baseline was recorded using the Brief Pain Inventory (BPI). The BPI is an inventory of subject-reported questions, where for each pain severity item the response scale is 0 = No Pain and 10 = Worst Pain You Can Imagine. The questions refer to pain in the last week: at its worst, at its least, on the average, and right now. Adequate pain control was defined as a score of <=4 on question 5 of the BPI. Inadequate pain control was defined as a score >4 on question 5 of the BPI. Question 5 of the BPI asked participants to rate their pain by circling the number that best describes their pain on the average scale from 0 to 10 (with 0=no pain and 10=worst pain imaginable). | The population consisted of all participants for which a BPI value was avaialble at Month 12. | Posted | Number | Percentage of Participants | Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Baseline (Day 1) | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consisted of all participants for which WOMAC VA 3.0 data for joint stiffness and limiation in physical function were available at Baseline. | Posted | Number | Percentage of Participants | Baseline (Day 1) |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 1 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario McMaster Osteoarthritis (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consisted of all participants for which a WOMAC VA 3.0 measurement was available at Month 1. | Posted | Number | Percentage of Participants | Month 1 |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 3 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 3. | Posted | Number | Percentage of Participants | Month 3 |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 6 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consisted of all participants for which WOMAC VA 3.0 data were available at Month 6. | Posted | Number | Percentage of Participants | Month 6 |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 9 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consistated of all participants for which WOMAC VA 3.0 data were available at Month 9. | Posted | Number | Percentage of Participants | Month 9 |
|
|
|
| Secondary | Percentage of Participants Who Reported Adequate Relief From Joint Stiffness or Limitation in Physical Function at Month 12 | Joint stiffness or limitation in physical function was evaluated using the Western Ontario and McMasters Universities (WOMAC) visual analog (VA)3.0 Index. The WOMAC VA 3.0 is a self-administered, tri-dimensional, disease-specific health status measure. It probes clinically important, subject-relevant symptoms in the areas of pain, joint stiffness and physical function in subjects with osteoarthritis of the knee. The index consists of 24 questions (5 pain, 2 stiffness and 17 physical function) and uses a VA scale of 0-500 mm for pain, 0-200 mm for stiffness, and 0-1700 for physical limitation with higher scores indicating poorer outcomes. Adequate pain was defined as participants reporting less than 4 on the BPI average pain scale. | The population consisted of all participants for which WOMAC VA 3.0 data was available at Month 12. | Posted | Number | Percentage of Participants | Month 12 |
|
|
|
| 11 |
| 548 |
| 0 |
| 548 |
| EG001 | Participants With Inadequate Pain Relief | Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline. | 25 | 639 | 0 | 639 |
| Angina Unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abdominal Distention | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Localized Infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Neutropenic Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Periumbilical Abscess | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Burns Third Degree | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Radius Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Wrist Fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Foot Deformity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Bladder Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Chronic Lymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Malignant Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Haemorrhagic Stroke | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Parkinson's Disease | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Calculus Bladder | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Renal Colic | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Urethral Sclerosis | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Chronic Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.