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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-184181 | Registry Identifier | JapicCTI |
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The purpose of this survey is to evaluate the long-term safety of Rasagiline (AZILECT) in patients with Parkinson's disease in daily clinical practice and also collect efficacy information.
The drug being tested in this survey is called rasagiline tablet. This tablet is being tested to treat people with Parkinson's disease.
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the rasagiline tablet in the routine clinical setting. The planned number of observed patients will be approximately 1000.
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rasagiline 1 mg | Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rasagiline | Drug | Rasagiline Tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | 24 months |
| Number of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). |
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Inclusion Criteria:
-Patients with Parkinson's disease should be surveyed.
Exclusion Criteria:
-Participants who have contraindications on package insert of rasagiline.
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Patients with Parkinson's disease treated with Rasagiline 1 mg tablets as part of routine medical care.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38124528 | Derived | Hattori N, Kajita M, Fujimoto S, Izutsu M, Fernandez J. Safety and effectiveness of rasagiline in patients with Parkinson's disease in Japan: a post-marketing surveillance study. Expert Opin Drug Saf. 2024 Jan;23(1):79-88. doi: 10.1080/14740338.2023.2293207. Epub 2023 Dec 20. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with a historical diagnosis of Parkinson's disease were enrolled. Participants received rasagiline as part of a routine medical care.
Participants took part in the survey at 148 investigative sites in Japan, from 1 November 2018 to 31 October 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rasagiline 1 mg | Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rasagiline 1 mg | Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. |
| 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 | Number of Participants Who Had One or More Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | No | 24 months |
|
|
24 months
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
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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 | Rasagiline 1 mg | Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2021 | Oct 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2022 | Oct 23, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
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| Baseline, Up to Month 24 (Final Assessment Point) |
| 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 |
|
| Region of Enrollment | All participants were enrolled in Japan. | Count of Participants | Participants |
|
| Duration of Diagnosis of Parkinson's Disease | Mean duration between the first diagnosis of Parkinson's disease and the start of the study was reported. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Years |
|
| Healthcare Category | Participants were categorized as outpatient and inpatient. | Count of Participants | Participants |
|
| Medical Complications | Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above. | Count of Participants | Participants |
|
| Dementia | Count of Participants | Participants |
|
| Height | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Centimeters (cm) |
|
| Weight | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Kilograms (kg) |
|
| Smoking Classification | Unknown: Data could not be collected. | Count of Participants | Participants |
|
| Modified Hoehn & Yahr Stage | Modified Hoehn & Yahr Stage represented severity for symptoms of Parkinson's disease progress. The Stage of Modified Hoehn & Yahr were assigned from Stage 0 (Asymptomatic) to Stage 5 (Wheelchair bound or bedridden unless aided (unable to walk even if aided)). | Count of Participants | Participants |
|
| Levodopa Use at Initiation of Treatment with the Study Drug | Count of Participants | Participants |
|
| Wearing-off Phenomenon | The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug. | Count of Participants | Participants |
|
| Dyskinesia | The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug. | Count of Participants | Participants |
|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Unified Parkinson's Disease Rating Scale (UPDRS) retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items were scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Scores on a Scale |
|
| Tremor Score | UPDRS retains the four-scale structure with a reorganization of the various subscales; Part I: 4 items, Part II: 13 items, Part III: 14 items, and Part IV: 11 items. Each item on Part III has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe, some items were scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). Tremor score was rated 0-28 based on 2 items of the UPDRS. Higher scores represent more severe symptom of tremor. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Scores on a Scale |
|
| Akinesia/Hypokinesia Score | UPDRS retains the four-scale structure with a reorganization of the various subscales; Part I: 4 items, Part II: 13 items, Part III: 14 items, and Part IV: 11 items. Each item on Part III has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe, some items were scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). Akinesia/hypokinesia score was rated 0-36 based on 5 items of the UPDRS. Higher scores represent more severe symptom of akinesia/hypokinesia. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Scores on a Scale |
|
| Rigidity Score | UPDRS retains the four-scale structure with a reorganization of the various subscales; Part I: 4 items, Part II: 13 items, Part III: 14 items, and Part IV: 11 items. Each item on Part III has 0-4 ratings, where 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe, some items were scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). Rigidity score was rated 0-20 based on one item of the UPDRS. Higher scores represent more severe symptom of rigidity. | The number analyzed is the number of participants with data available for analysis. | Mean | Standard Deviation | Scores on a Scale |
|
| Participants |
|
|
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Posted | Count of Participants | Participants | No | 24 months |
|
|
|
| Secondary | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome). | Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Up to Month 24 (Final Assessment Point) |
|
|
|
| 11 |
| 961 |
| 121 |
| 961 |
| 136 |
| 961 |
| Cellulitis | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA/J v24.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Malignant neoplasm of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J v24.1 | Systematic Assessment |
|
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Thyroid cyst | Endocrine disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Neuroleptic malignant syndrome | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Sudden onset of sleep | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Aqueductal stenosis | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Cardiomyopathy | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Aortic dissection | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Blood pressure fluctuation | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Rectal stenosis | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Congestive hepatopathy | Hepatobiliary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA/J v24.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Drowning | General disorders | MedDRA/J v24.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA/J v24.1 | Systematic Assessment | The reasons of events are not determined because assessment findings were insufficient to specify the reason. |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA/J v24.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Fibrin D dimer increased | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA/J v24.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA/J v24.1 | Systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA/J v24.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA/J v24.1 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |