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This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pimavanserin tartrate (ACP-103) | Experimental | Tablets taken once daily by mouth at 20, 40, or 60 mg doses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pimavanserin tartrate (ACP-103) | Drug | Tablets taken once daily by mouth at 20, 40, or 60 mg doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | Number (%) of patients with drug-related treatment-emergent AEs | From first to last study drug dose plus 30 days |
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Inclusion Criteria-
Exclusion Criteria-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danbury | Connecticut | 06810 | United States |
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This was an open-label extension study, including patients with idiopathic Parkinson's Disease (PD) who had completed study ACP-103-006 (PD psychosis [PDP]) or study ACP-103-004 (PD with dyskinesias) and would benefit from continued pimavanserin treatment, as judged by the investigator.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pimavanserin | All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pimavanserin | All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability. |
| Units | Counts |
|---|---|
| Participants |
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| 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 Patients With Drug-related Treatment-emergent Adverse Events (AEs) | Number (%) of patients with drug-related treatment-emergent AEs | Patients treated with at least one dose of study medication | Posted | Count of Participants | Participants | From first to last study drug dose plus 30 days |
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Study treatment (median treatment duration: 475 days)
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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 | Pimavanserin | All patients started treatment with pimavanserin 20 mg/day. Based on clinical benefit and Investigator judgment, dose escalation to 40 mg and 60 mg was allowed, after a minimum of 2 and 4 weeks treatment duration, respectively. Dose reductions to 40 and/or 20 mg/day were allowed for the management of AEs or intolerability. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Dir. Medical Information and Medical Communications | ACADIA Pharmaceuticals Inc. | 858-261-2897 | medicalinformation@acadia-pharm.com |
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| ID | Term |
|---|---|
| C510793 | pimavanserin |
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| Withdrawal by Subject |
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| Physician Decision |
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| Sponsor Decision |
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| Not in Predefined Categories |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinical Global Impression of Severity | The Clinical Global Impression-Severity (CGI-S) Scale is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes more severe depression. | Mean | Standard Deviation | Score on a scale |
|
| UPDRS tremor | The Unified Parkinson's Disease Rating Scale (UPDRS) tremor score range was 0 (absent) to 4 (marked; interferes with most activities). | Median | Full Range | Score on a scale |
|
| UPDRS duration of dyskinesias | The Unified Parkinson's Disease Rating Scale (UPDRS) duration of dyskinesias score was 0 (none) to 4 (76-100% present during the waking day). | Median | Full Range | Score on a scale |
|
| UPDRS disability of dyskinesias | The Unified Parkinson's Disease Rating Scale (UPDRS) disability of dyskinesias score was 0 (not disabling) to 4 (completely disabling). | Median | Full Range | Score on a scale |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 8 |
| 39 |
| 18 |
| 39 |
| 34 |
| 39 |
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Depressed level of consciousness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Mental status change | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Confusional state | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dyskinesia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Orthostatic hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Haematocrit decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Low density lipoprotein increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Lymphocyte count decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Pyuria | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Retyculocyte count decreased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Facial wasting | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Buttock pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Gait disturbance | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Paranoia | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Benign prostatic hypertrophy | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
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Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.