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Huntington disease (HD) is a hereditary neurodegenerative disorder causing impairment in movement, behavioral dysfunction and dementia. The movement disorder is mainly characterized by chorea (involuntary movements) and a progressive loss of voluntary movement causing a substantial functional impairment over time. The study will assess the long-term safety of pridopidine and the treatment effects during long-term, open-label treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pridopidine | Experimental | 45mg bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pridopidine | Drug | 45mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With at Least One Adverse Event | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. |
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Inclusion Criteria:
Subject is able to, and has provided written Informed Consent prior to any study related procedure.
Patient has completed the HART (ACR16C009) or the PRIDE-HD (TV7820- CNS-20002) studies and had remained on IMP during the full on-treatment part of the study (including de-escalated patients) or has transitioned from the Open-HART pre-virtualization study period.
Willing and able to take oral medication and able to comply with the study specific procedures.
Patient has a wireless internet connection at home (and/or applicable locations) at the first remote visit.
Patient has the ability to transition from in-person study visits to virtual study visits. The first remote visit (RV1) will take place within approximately 30 days after the last in-person visit.
Exclusion Criteria:
Ongoing treatment with tetrabenazine or deutetrabenazine, seizure threshold lowering medications, or certain antipsychotics and antidepressants.
Newly instigated or changed treatment with neuroleptics/antipsychotics
Use of tricyclic antidepressants or class I & III antiarrhythmics at any time during the study period.
Severe intercurrent illness that, in the opinion of the Investigator (or qualified designee), may put the subject at risk when continuing participation in the study.
Alcohol and/or drug abuse as defined by the Diagnostic and Statistical Manual - Fourth Edition - Text Revision criteria for substance abuse - this includes the illicit use of cannabis.
Subjects with a known history of epilepsy or a history of febrile seizure(s) or seizure(s) of unknown cause.
Females who are pregnant or lactating.
Females who are of child bearing potential and not taking adequate contraceptive precautions (either oral, barrier or chemical contraceptives) are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.
Known allergy to any ingredients of the trial medication.
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| Name | Affiliation | Role |
|---|---|---|
| See Central Contact section for questions about | study officials | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32508327 | Background | McGarry A, Auinger P, Kieburtz K, Geva M, Mehra M, Abler V, Grachev ID, Gordon MF, Savola JM, Gandhi S, Papapetropoulos S, Hayden M. Additional Safety and Exploratory Efficacy Data at 48 and 60 Months from Open-HART, an Open-Label Extension Study of Pridopidine in Huntington Disease. J Huntingtons Dis. 2020;9(2):173-184. doi: 10.3233/JHD-190393. | |
| 28826192 |
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The study recruited adult patients with Huntington's Disease (HD) who had completed studies ACR16C009 (NCT00724048) or TV7820-CNS-20002 (NCT02006472). The first patient was recruited on 24 Mar 2011, and the last patient completed the trial on 5 Jan 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pridopidine | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pridopidine | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| 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 Patients With at Least One Adverse Event | Safety analysis set, including all enrolled patients who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years |
|
|
From signing of the informed consent through the end of the follow-up period, which was defined as 30 days after the final study visit in an individual patient, an average of 2.8 years
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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 | Pridopidine | Pridopidine 45 mg twice daily (bid), taken once in the morning and once in the afternoon. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis cornonary artery | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Systematic Assessment |
The study was stopped at Sponsor discretion/request; last patient last visit was 5 Jan 2018.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prilenia | Prilenia | +972 775558 | 482 | info@prilenia.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 | Jun 29, 2017 | Nov 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2018 | Nov 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C483720 | pridopidine |
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| Baseline and at Month 12, 24, 36, 48, 60, and 72 |
| McGarry A, Kieburtz K, Abler V, Grachev ID, Gandhi S, Auinger P, Papapetropoulos S, Hayden M. Safety and Exploratory Efficacy at 36 Months in Open-HART, an Open-Label Extension Study of Pridopidine in Huntington's Disease. J Huntingtons Dis. 2017;6(3):189-199. doi: 10.3233/JHD-170241. |
| Death |
|
| Withdrawal by parent/guardian |
|
| Protocol Violation |
|
| Non-compliance with study drug |
|
| Lost to Follow-up |
|
| Various |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Data available for 132 of 134 patients. | Mean | Standard Deviation | kg |
|
|
| Secondary | Unified Huntington's Disease Rating Scale (UHDRS) Total Motor Score (TMS) | TMS was defined as the sum of all UHDRS motor domains ratings. The motor section of the UHDRS assesses motor features of Huntington's Disease (HD) with standardized ratings of oculo-motor function, dysarthria, chorea, dystonia, gait, and postural stability. Each of 31 assessments is rated on a scale of 0 (normal) to 4 (marked impairment) for a TMS range of 0-124. | Full analysis set, comprising all enrolled patients who received at least 1 dose of study drug and had a baseline and at least 1 post-baseline UHDRS-TMS assessment. | Posted | Mean | Standard Deviation | score on a scale | Baseline and at Month 12, 24, 36, 48, 60, and 72 |
|
|
|
| 8 |
| 134 |
| 31 |
| 134 |
| 119 |
| 134 |
| Bungle branch block right | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Alcoholic pancreatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oesophageal spasm | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Endocarditis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Starvation | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Status migrainosus | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Aortic valve incompetence | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Mitral valve incompetence | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Abdominal tenderness | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diverticulum | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gingival disorder | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth impacted | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA (14.1) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cyst | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Facial pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Enterococcal infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Gingival infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Oral fungal infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Heat exhaustion | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Spinal column injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth injury | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Electrocardiogram abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Albumin globulin ratio increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Antibiotic resistant Staphylococcus test positive | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood creatinine decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (14.1) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Creatinine renal clearance abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Electrocardiogram ST-T change | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Electrocardiogram T wave abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Globulins increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Heart rate abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Occult blood positive | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Protein total increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Smear cervix abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Water intoxication | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Arthraglia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Ostenopenia | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
|
| Chorea | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Speech disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tongue biting | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bradykinesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Restless legs syndrome | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Anger | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Panic attack | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bruxism | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Delusion | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Obsessive-compulsive disorder | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Alcohol abuse | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Anhedonia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Bradyphrenia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Depressive symptom | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Inappropriate affect | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Obsessive thoughts | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Perseveration | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pressure of speech | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rapid eye movements sleep abnormal | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tachyphrenia | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment |
|
| Michurition urgency | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
|
| Genital rash | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Grunting | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper respiroatry tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Generalised erythema | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Scar | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Immobilisation prolonged | Social circumstances | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Peripheral coldness | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
|
There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Data and results owned by Sponsor. Results can be used by institution for (a) internal non-commercial research, education and patient care, and (b) as required under applicable laws and regulations. Other uses require prior written consent of Sponsor.
| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|
| Month 24 |
|
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| Month 36 |
|
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| Month 48 |
|
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| Month 60 |
|
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| Month 72 |
|
|