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The study was terminated because of concerns about subject attrition between the 5- and 10-year visits. A nested PMCF study at 10 years was proposed to the regulatory body and it was agreed this was an acceptable approach
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This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
This study will be multi-centre and non-comparative. Subjects will be recruited and followed up at similar intervals to reflect the standard clinical practice and intended population for wider use of the device.
157 non-randomised subjects will be recruited from approximately 15 sites. A maximum of 30 subjects may be recruited from one site. More than one implanting surgeon may recruit subjects at each site as a designated sub-Investigator.
The primary objective of this PMCF study is to confirm device survivorship of the GLOBAL ICON stemless humeral component at 24 months post-operative.
The secondary objectives include the evaluation of clinical performance, radiographic performance and safety outcomes at 3, 12, 24, 60 and 120 months post-operatively.
Tertiary endpoints in the study will include a mean change from baseline for the Adjusted Constant-Murley Score, the Oxford Shoulder Score, the EQ-5D-5L dimension score and EQ-VAS scores. Radiographic evidence of aseptic loosening and periprosthetic fracture survivorship of the GLOBAL ICON stemless humeral component will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Global ICON | Other | The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Global ICON | Device | The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Composite Clinical Success | Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events. | At 24 months |
| Adjusted Constant-Murley Shoulder Assessment Score | Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. | 24 Months |
| Continuous Radiolucent Line | X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening. | 24 months |
| Kaplan Meier Survivorship | Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. |
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Inclusion Criteria:
Severely painful and/or severely disabled Non-Inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis Patient is willing and able to complete the required post-operative schedule Patient has provided written Informed Consent to participate
Exclusion Criteria:
Subjects under the age of 21 or over the age of 80 on the day of consent Subjects who have not reached skeletal maturity, regardless of age Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components Bone that is too soft or porous to support the implant or that is too hard or brittle to allow for proper bone preparation and fixation, i.e osteoporosis or sclerotic bone, where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid Fractures of the proximal humerus that could compromise the fixation of the GLOBAL ICON stemless humeral components Subjects who have undergone previous treatment on the study shoulder that may compromise fixation of the GLOBAL ICON stemless humeral components Revision of a failed hemi, total or reverse shoulder arthroplasty Active local or systemic infection Absent, irreparable or nonfunctional rotator cuff or other essential muscles Subject is receiving, or is scheduled to receive, treatment that the Investigator considers could affect bone quality, such as chemotherapy or high dose corticosteroids Subjects who, at the point of enrolment, already have a GLOBAL ICON shoulder replacement or are scheduled to receive, a contralateral shoulder replacement device Subjects who are known to be pregnant or breastfeeding Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects with a known medical condition that the Investigator believes would impact the study outcomes (including, but not limited to osteomyelitis, Paget's disease, neuropathies such as Charcot's disease, metastatic or neoplastic disorders) Known polyethylene and/or metal sensitivity or allergy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston General Hospital | Kingston | K7L 2V7 | Canada | |||
| Vulpius Klinik |
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Patients were selected for recruitment into the study from the general diagnosis population defined as total shoulder arthroplasty (TSA). The investigation was conducted at 12 centers.
| ID | Title | Description |
|---|---|---|
| FG000 | GLOBAL ICON Stemless Shoulder System | Study participants who received a GLOBAL ICON Stemless shoulder system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GLOBAL ICON Stemless Shoulder System | Study participants who received a GLOBAL ICON Stemless shoulder system |
| 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 With Overall Composite Clinical Success | Percentage of participants with overall composite clinical success at 24 months was reported. Composite success was achieved if each of the following criteria was met: (1) Radiographs indicated that there was no continuous radiolucent line (RLL) around the GLOBAL ICON stemless humeral component, with continuous RLL defined as a radiolucent line greater than (>) 1millimeter (mm) in all five zones of either anterior-posterior (AP) or Axillary views (2) The adjusted Constant-Murley score was greater than 85, with the adjustment based on the method of Constant (3) No GLOBAL ICON humeral component was removed for any reason (4) There was no device-related serious adverse events. | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, N (Overall number of participants analyzed) signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | At 24 months |
|
Day 0 (Day of surgery) up to 60 months
All-Cause Mortality: Analysis population included all enrolled participants. For SAEs and Non-SAEs: Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so.
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 | GLOBAL ICON Stemless Shoulder System | Study participants who received a GLOBAL ICON Stemless shoulder system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
Due to investigators decision study was terminated at 5 years. Therefore, results are reported only up to 5 years (60 months).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Whalen | DePuy Synthes | 574-404-9399 | dwhalen@its.jnj.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 14, 2020 | Mar 19, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 11, 2021 | Mar 19, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
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| 24 months |
| Device-related Serious Adverse Events | Adverse events are any untoward health issues that occur when compared to a participant's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function. | 24 months |
| At Baseline (Day 0), 3, 12, 24, and 60 months |
| Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems). | At Baseline (Day 0), 3, 12, 24, and 60 months |
| Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. | At Baseline (Day 0), 3, 12, 24, and 60 months |
| Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. | At Baseline (Day 0), 3, 12, 24, and 60 months |
| Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening. | Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months |
| Bad Rappenau |
| 74906 |
| Germany |
| Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift | Hanover | 30625 | Germany |
| Sportklinik Ravensburg | Ravensburg | 88214 | Germany |
| Treant Hospital | Emmen | NL-7824AA | Netherlands |
| Groene Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Tergooi Hospital | Hilversum | Netherlands |
| Woodend Hospital | Aberdeen | AB252ZB | United Kingdom |
| The Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| North Bristol NHS Trust | Bristol | BS10 5NB | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| City Hospital | Nottingham | NG5 1PB | United Kingdom |
| Adverse Event |
|
| Other |
|
| Started but not treated with GLOBAL ICON |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG000 | GLOBAL ICON Stemless Shoulder System | Study participants who received a GLOBAL ICON Stemless shoulder system. |
|
|
| Primary | Adjusted Constant-Murley Shoulder Assessment Score | Constant-Murley Score on operative shoulder adjusted for gender and age. Please note that scores are adjusted to reflect gender and age of participants. The Constant-Murley score is divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100) Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant is 0-178.6; the range for the Adjusted Constant-Murley score in a female participant is 0-192.3. Please note the calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. | Study participants who received a GLOBAL ICON Shoulder system. | Posted | Mean | Standard Deviation | Units on a scale | 24 Months | Implants | Implants |
|
|
|
| Primary | Continuous Radiolucent Line | X-rays are reviewed by an independent radiographic reviewer to determine if a 1 mm wide or greater, continuous radiolucent line around the entire bony border of the GLOBAL ICON Stemless Shoulder implant exists. Such a line may indicate the implant is loosening. | All participants who received a GLOBAL ICON Stemless Shoulder were evaluated radiographically at 24 months for the presence of a continuous radiolucent line around the implant that was greater than 1mm wide. | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Primary | Kaplan Meier Survivorship | Kaplan Meier Survival Estimate is based upon the number of GLOBAL ICON implants remaining in the study and the number of GLOBAL ICON implants that have been revised (surgically removed from participants). | Study participants who received a GLOBAL ICON Shoulder System. | Posted | Number | 95% Confidence Interval | Percentage of implants | 24 months | Implants | Implants |
|
|
|
| Primary | Device-related Serious Adverse Events | Adverse events are any untoward health issues that occur when compared to a participant's normal health baseline. Serious adverse events include health events that have led to death or a serious deterioration in health that resulted in life threatening illness/injury, permanent impairment of a body structure, required hospitalization or required medical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or function. | Study participants who received a GLOBAL ICON shoulder system | Posted | Count of Participants | Participants | 24 months |
|
|
|
| Secondary | Mean Adjusted Constant-Murley Score at Baseline, 3, 12, 24, and 60 Months Post-operative | Constant-Murley Score was adjusted to reflect gender and age of participants. The Constant-Murley score was divided into four subscales, including pain (15 points maximum), activities of daily living (20 points maximum), ROM (40 points maximum), and strength (25 points maximum). The higher the score, the higher the quality of function (minimum 0, maximum 100). Adjustment may lead to scores above 100 depending on age of group analyzed. The range for the Adjusted Constant-Murley score in a male participant was 0-178.6; the range for the Adjusted Constant-Murley score in a female participant was 0-192.3. The calculations of the maximum Adjusted score assume a perfect score (100) in 100 year old male and female participants. | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | At Baseline (Day 0), 3, 12, 24, and 60 months |
|
|
|
| Secondary | Mean Oxford Shoulder Score at Baseline, 3, 12, 24, and 60 Months Post-operative | The Oxford Shoulder Score (OSS) was a patient-based questionnaire used to assess shoulder pain after surgery. It consisted of 12 questionnaire items with 5 ordinal response options for each question. Each response was scored from 0 to 4 points (4 = best/least problems and 0=worst/unbearable pain). All item scores across 12 questions were summed to produce a scale of 0-48 (where a higher score reflected best/least problems). | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number of participants analyzed) signifies number participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a Scale | At Baseline (Day 0), 3, 12, 24, and 60 months |
|
|
|
| Secondary | Mean EuroQol-5 Dimension 5-Level (EQ-5D-5L) Scores by Dimensions at Baseline, 3, 12, 24, and 60 Months Post-operative | Mean EQ-5D-5L scores by dimensions at baseline, 3, 12, 24, and 60 months were reported. EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ Visual Analogue Scale (EQ-VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5-item index score was transformed into a utility score between 0 (worst health state) and 1 (best health state). Higher score indicated good health. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a Scale | At Baseline (Day 0), 3, 12, 24, and 60 months |
|
|
|
| Secondary | Mean Visual Analog Scale (EQ-VAS) Score at Baseline, 3, 12, 24, and 60 Months Post-operative | EQ-5D-5L consisted of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicated improvement. | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number of participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Unit on a scale | At Baseline (Day 0), 3, 12, 24, and 60 months |
|
|
|
| Secondary | Number of Participants With Radiographic Evidence of Aseptic Loosening of the Global Icon Stemless Humeral Component Immediate Post-operative and 3, 12, 24, and 60 Months Post-operative | Number of participants with radiographic evidence of aseptic loosening of the global icon stemless humeral component immediate post-operative and 3, 12, 24 and 60 months post-operative were reported. Aseptic Loosening was evaluated using all available imaging. Progressing radiolucencies and/or stress shielding indicated aseptic loosening. | Safety population included all participants who were enrolled and were either implanted with the GLOBAL ICON stemless humeral component or an attempt was made to do so. Here, n (number analyzed) signifies number participants evaluable at specified time points. | Posted | Count of Participants | Participants | Immediate post operative (0-10 Days), at 3, 12, 24, and 60 months |
|
|
|
| 3 |
| 171 |
| 75 |
| 156 |
| 100 |
| 156 |
| Angina pectoris | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastrointestinal polyp | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rectal polyp | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Unevaluable event | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Infective exacerbation of bronchiectasis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Kidney infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Medical device site joint infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Periprosthetic fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Traumatic arthrosis | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Meniscal degeneration | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vertebral osteophyte | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Adenoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Adrenal gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pancreatic carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Occipital neuralgia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint prosthesis user | Social circumstances | MedDRA version 17.1 | Non-systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Varicose vein | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dilatation atrial | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Extrasystoles | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Silent myocardial infarction | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Peutz-Jeghers syndrome | Congenital, familial and genetic disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Basedow's disease | Endocrine disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Age-related macular degeneration | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Entropion | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Epiretinal membrane | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Meibomian gland dysfunction | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Anal incontinence | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Inguinal hernia strangulated | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Early satiety | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hepatic lesion | Hepatobiliary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Back injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal foreign body | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoradionecrosis | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sternal Fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Ulnar nerve injury | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA version 17.1 | Non-systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| HLA marker study positive | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Staphylococcus test positive | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA version 17.1 | Non-systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bone infarction | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Greater trochanteric pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint noise | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscle fatigue | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Soft tissue swelling | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Nasopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 17.1 | Non-systematic Assessment |
|
| Acquired syringomyelia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Lumbar radiculopathy | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pseudoradicular syndrome | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Spinal claudication | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Device loosening | Product Issues | MedDRA version 17.1 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Breast disorder | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Breast swelling | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA version 17.1 | Non-systematic Assessment |
|
Not provided
|
| 12 Months |
|
|
| 24 Months |
|
|
| 60 Months |
|
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 60 Months |
|
|
|
| Mobility: 12 Months |
|
|
| Mobility: 24 Months |
|
|
| Mobility: 60 Months |
|
|
| Self-Care: Baseline |
|
|
| Self-Care: 3 Months |
|
|
| Self-Care: 12 Months |
|
|
| Self-Care: 24 Months |
|
|
| Self-Care: 60 Months |
|
|
| Usual Activities: Baseline |
|
|
| Usual Activities: 3 Months |
|
|
| Usual Activities: 12 Months |
|
|
| Usual Activities: 24 Months |
|
|
| Usual Activities: 60 Months |
|
|
| Pain/Discomfort: Baseline |
|
|
| Pain/Discomfort: 3 Months |
|
|
| Pain/Discomfort: 12 Months |
|
|
| Pain/Discomfort: 24 Months |
|
|
| Pain/Discomfort: 60 Months |
|
|
| Anxiety/Depression: Baseline |
|
|
| Anxiety/Depression: 3 Months |
|
|
| Anxiety/Depression: 12 Months |
|
|
| Anxiety/Depression: 24 Months |
|
|
| Anxiety/Depression: 60 Months |
|
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 60 Months |
|
|
|
| 12 Months |
|
|
| 24 Months |
|
|
| 60 Months |
|
|