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Additional long-term safety data no longer needed
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| Name | Class |
|---|---|
| Kyowa Kirin Co., Ltd. | INDUSTRY |
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This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.
Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Istradefylline | Drug | Oral istradefylline (KW-6002) 20 or 40 mg once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Measured by Adverse Events | Investigation of the long-term tolerability and safety of istradefylline | Every 2 months up to 32 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Sussman, MD | Kyowa Kirin, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyowa Pharmaceutical Inc. | Princeton | New Jersey | 08540 | United States |
Subjects completing 6002-INT-001 immediately before entering the study had an interruption of study drug of 30 days or less. Qualifying subjects with an interruption of more than 30 days had their baseline visit after laboratory tests results were reviewed by the Investigator.
73 study centers in the US and Canada recruited subjects from the initiation date (28 October 2005). Patients who had previously participated in Study 6002-INT-001 were eligible to participate in this follow-on safety study,and hence had been taking istradefylline for at least a year.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
503 subjects took at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety as Measured by Adverse Events | Investigation of the long-term tolerability and safety of istradefylline | Safety analysis set - all subjects who took at least one dose of study drug. 1 subject of the 504 enrolled did not take study drug and is not included in the safety analysis set. | Posted | Number | participants | Every 2 months up to 32 months |
|
|
Dosing to end of 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 | Single Arm | Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Parkinson's disease | Nervous system disorders | MedDRA (7.0) | Systematic Assessment | Worsening of Parkinson's disease |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
The Sponsor decided to terminate the study early (not for safety reasons); as a result 323 subjects discontinued early. Mean duration of therapy was 18.7 months (0.4 to 31.4 months); median duration was 21.0 months. Total exposure 767 subject years.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Kyowa Hakko Kirin Pharma, Inc. | 609-919-1100 | mcantillon@kyowa-kirin-pharma.com |
Not provided
| 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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Not provided
| ID | Term |
|---|---|
| C111599 | istradefylline |
Not provided
Not provided
Not provided
Not provided
Not provided
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| Lack of Efficacy |
|
| Not including due to early termination |
|
| Study termination by Sponsor |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | 61 centers in the US and 12 centers in Canada recruited at least 1 subject | Number | participants |
|
|
| 201 |
| 503 |
| 276 |
| 503 |
|
| Syncope | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cervical myelopathy | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Myasthenia gravis | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Paraparesis | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Radiculitis lumbosacral | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Localised osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Spondylosis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Kyphoscoliosis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pain in extemity | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Caustic injury | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Closed head injury | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Ligament injury | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Postoperative infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Diverticultis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Infected skin ulcer | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Pneumonia staphylococcal | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Markedly reduced dietary intake | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Atrioventricular block | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cardiomegaly | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Abdominal strangulated hernia | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Coeliac disease | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Mallory-Weiss syndrome | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Acute respiratory distress snydrome | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Death | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Gait abnormal | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
|
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (7.0) | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Colpocele | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Prostatic disorder | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Urogenital prolapse | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (7.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Vascular pseudoaneurysm | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Malignant hypertension | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA (7.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Renal insufficiency | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cardiac pacemaker revision | Surgical and medical procedures | MedDRA (7.0) | Systematic Assessment |
|
| Medical device removal | Surgical and medical procedures | MedDRA (7.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (7.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Gangrenous cholecystitis | Hepatobiliary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (7.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (7.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (7.0) | Systematic Assessment |
|
| Accident | Injury, poisoning and procedural complications | MedDRA (7.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA (7.0) | Systematic Assessment | Worsening of Parkinson's disease |
|
| Constipation | Gastrointestinal disorders | MedDRA (7.0) | Systematic Assessment |
|
| Nausea | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Oedema peripheral | Cardiac disorders | MedDRA (7.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (7.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Freezing phenomenon | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Lightheadedness | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (7.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (7.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (7.0) | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |