Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002339-26 | EudraCT Number |
Not provided
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Study stopped due to lack of efficacy.
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Patients who have completed one of the core trials (E2007-E044-301 or E2007-A001-302) and who meet inclusion/exclusion criteria will be enrolled and will enter the Titration Phase, lasting 4 weeks (weeks 0-3) followed by the Maintenance Phase, lasting 52 weeks (weeks 4-56). All patients will receive active study drug. During the Titration Phase, patients will receive E2007 2 mg once daily (o.d.) for 2 weeks followed by 4 mg o.d. for 2 weeks. During the Maintenance Phase, patients will receive 4 mg o.d. Patients not tolerating the study drug at 4 mg, will be allowed to down titrate to 2 mg. Patients not tolerating 2 mg will be withdrawn from the study.
Patients will have visits at 2, 4, 8, 20, 32, 44, and 56 weeks after study entry. In addition, a follow-up visit will occur 4 weeks after study treatment has ended (week 60).
A home diary will be completed in which patients rate themselves as either:
These entries will be completed every half hour during the waking day and will be completed for 3 consecutive days following the visits at weeks 4, 8, 20, 32 and 44, and three days prior to the visits at weeks 56 and 60. At entry into the study (week 0) and at weeks 8, 20, 32, 44 and 56, the Unified Parkinson's Disease Rating Scale (UPDRS), Clinician's Global Impression of Change (CGIC) and Clinical Global Impression of Tolerance (CGIT) will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E2007 | Experimental | During the first two weeks of the study, Patients received 1 x 2mg E2007 tablet. At the week 2 visit, patients who tolerated the 2 mg/day dose were up-titrated to receive 4mg/day (2 x 2 mg E2007 tablets). Patients not tolerating the 4 mg dose were allowed to down titrate to 2 mg. Patients who did not tolerate the 2 mg dose were withdrawn from the study. Patients returned at week 4, if their tolerance to the 4 mg/day dose was acceptable they remained on this dose for the maintenance phase of the study. If at any time their tolerance declined, they were to return for an unscheduled visit and the daily dose was reduced to 2 mg. If at any stage, 2 mg day wass not tolerated, the patient was withdrawn from the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E2007 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
Not provided
Inclusion Criteria:
Male or female patients with idiopathic PD who have fulfilled the entry criteria to either E2007-E044-301 or E2007-A001-302 and have completed that study up to and including the final efficacy visit. Patients will not be eligible if they withdrew from the core study prior to the final efficacy visit for any reason including lack of efficacy. Patients with SAEs which are ongoing or possibly or probably related to the study drug, will not be eligible for this study. Patients with ongoing adverse events categorized as severe and thought to be related to E2007 should not be entered. Patients with mild or moderate adverse events thought to be related to E2007 can be entered to the study if the investigator considers it safe.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Squillacote, M.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps-University Marburg | Marburg | 35039 | Germany |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
| FG001 | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Data comes from previous double-blind core studies (E2007-E044-301) and (E2007-A001-302). |
| 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 | Mean Change From Baseline in Total Daily OFF Time (Hours) During Open-label Extension Study | OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Safety Population- all subjects entering the open-label extension study who took at least 1 dose of perampanel | Posted | Mean | Standard Deviation | Hours | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
|
Adverse events (AEs) were defined as treatment emergent in this study if the start date of the event was on or after the start of study medication in this study. Adverse events that occurred 30 days after the last dose of study drug were 'post-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 | Perampanel (Placebo During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Parkinson's disease | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
Due to early termination, a limited number of subjects (only 2) completed this open-label extension study. The majority of subjects did not reach the scheduled Week 56 assessment. Many outcomes could only be analyzed to Week 68 as a result.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C551441 | perampanel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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Not provided
| Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. | Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
| Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. | Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
| Patient withdrew consent |
|
| Lack of therapeutic efficacy |
|
| Physician Decision |
|
| Other |
|
| Study termination by Sponsor |
|
| BG001 | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
| BG002 | Total | Total of all reporting groups |
| Number |
| Participants |
|
| Sex: Female, Male | Data comes from previous double-blind core studies (E2007-E044-301 and E2007-A001-302). Safety Population - All subjects entering the open-label extension study who took at least 1 dose of perampanel | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Data comes from previous double-blind core studies (E2007-E044-301 and E2007-A001-302). Safety population. | Number | Participants |
|
| OG001 | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. |
|
|
| Secondary | Mean Change From Baseline in Total Daily ON Time (Without Dyskinesias or With Non-troublesome Dyskinesias) (Hours) During Open-label Extension Study | ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. This outcome measure was based on data collected through use of a patient diary. | Safety Population | Posted | Mean | Standard Deviation | Hours | Baseline, Week 0, Week 4, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
|
|
|
| Secondary | Mean Change From Baseline in UPDRS Part II (ADL) Score in OFF State (Hours) During Open-label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part II assesses activities of daily living (ADL) based on 13 items, such as speech, hygiene, and falling. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-52. OFF state is when medication has worn off and is no longer providing benefits with regard to stiffness, slowness, and tremor. | Safety Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 0, Week, 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
|
|
|
| Secondary | Mean Change From Baseline in UPDRS Part III (Motor) Score in ON State (Hours) During Open- Label Extension Study | Unified Parkinson's Disease Rating Scale (UPDRS) is a standardized assessment of the symptoms and signs of Parkinson's Disease. Part III assesses motor activity, based on 14 items, such as gait, facial expression, and rigidity. Participants receive a score of 0-4 points per item, with a higher score indicating more severe symptoms, for a range of total possible scores of 0-56. ON state is when medication is providing benefits with regard to stiffness, slowness, and tremor. | Safety Population | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, Week 0, Week 8, Week 20, Week 32, Week 44, Week 56, Week 68 |
|
|
|
| 33 |
| 333 |
| 104 |
| 333 |
| EG001 | Perampanel (Perampanel 2 mg or 4 mg During Core Study) | Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study. | 57 | 664 | 201 | 664 |
| On and off phenomenon | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Akinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hyperkinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Muscle spasticity | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Device dislocation | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 10.0 | Systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Acute Psychosis | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Pathological gambling | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Suicidal attempt | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Acute left ventricular failure | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Abdomina strangulated hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Duodenal obstruction | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Duodenal polyp | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Femoral hernia | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Volvulus | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Kyphoscoliosis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Intervertebral discitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 10.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Chondrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Mycosis fungoides | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| On and off phenomenon | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 10.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 10.0 | Systematic Assessment |
|
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Week 8 |
|
| Week 20 |
|
| Week 32 |
|
| Week 44 |
|
| Week 56 |
|
| Week 68 |
|
| Week 20 |
|
| Week 32 |
|
| Week 44 |
|
| Week 56 |
|
| Week 68 |
|
| Week 20 |
|
| Week 32 |
|
| Week 44 |
|
| Week 56 |
|
| Week 68 |
|