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Treatment ineffective
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The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-8309B 1.0% | Experimental | AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months |
|
| AL-8309B 1.75% | Experimental | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
|
| Vehicle | Placebo Comparator | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-8309B Ophthalmic Solution | Drug |
| ||
| AL-8309B Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging | The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease. | Baseline, up to Month 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sally Scheib, Sr. Clinical Lead | Alcon Research | Study Director |
Not provided
This reporting group includes all enrolled subjects (772). A subject was considered enrolled if they met all of the inclusion criteria and none of the exclusion criteria.
Subjects were recruited from 48 study centers located in 14 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | AL-8309B 1.0% | AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months |
| FG001 | AL-8309B 1.75% | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| FG002 | Vehicle | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all enrolled subjects (772).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AL-8309B 1.0% | AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months |
| BG001 | AL-8309B 1.75% | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| 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 | Mean Annualized Lesion Enlargement Rate From Baseline as Assessed With Fundus Autofluorescence Imaging | The size of the retinal lesion was measured using the Heidelberg Retinal Angiography system at Baseline, Month 6, Month 12, Month 15, Month 18, Month 24, and Month 30. Images were collected in both eyes; however, one eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. Results were estimated from a longitudinal random effects regression model. A greater lesion growth rate may indicate a faster progression of the disease. | This analysis population included all treated subjects. A subject was considered treated if they had a first or last dosing date in the database. | Posted | Mean | 95% Confidence Interval | square millimeters per year | Baseline, up to Month 30 |
|
Adverse events were collected for the duration of the study (3 years, 2 month). Adverse events were obtained as solicited comments from the study subjects and as observations by the study Investigator as outlined in the study protocol.
This analysis population includes all treated subjects (768).
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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 | AL-8309B 1.0% | AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blepharitis | Eye disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Sager, Clinical Manager Group Leader | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Drug |
Inactive ingredients used as placebo comparator |
|
| Withdrew Consent |
|
| Lost to Follow-up |
|
| Noncompliance |
|
| Sponsor Decision |
|
| Did not attend final visit |
|
| Subject Decision |
|
| Randomization Error |
|
| Failed inclusion criteria |
|
| Transportation |
|
| Subject Moved |
|
| Protocol Deviation |
|
| BG002 | Vehicle | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | AL-8309B 1.75% | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
| OG002 | Vehicle | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months |
|
|
| 86 |
| 250 |
| 207 |
| 250 |
| EG001 | AL-8309B 1.75% | AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months | 96 | 258 | 212 | 258 |
| EG002 | Vehicle | AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months | 85 | 260 | 207 | 260 |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bundle branch block | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sick sinus syndrome | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Choledochal cyst | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal artery occlusion | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Death | General disorders | MedDRA | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Biliary tract disorder | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Cirrhosis alcoholic | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
|
| Anaphylactic shock | Immune system disorders | MedDRA | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Echinococciasis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA | Systematic Assessment |
|
| Labyrinthitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pancreatic abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Intraocular lens dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthroscopy | Investigations | MedDRA | Systematic Assessment |
|
| Catheterisation cardiac | Investigations | MedDRA | Systematic Assessment |
|
| Endoscopy | Investigations | MedDRA | Systematic Assessment |
|
| Investigation | Investigations | MedDRA | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA | Systematic Assessment |
|
| Renal function test abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Cardiac valve fibroelastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Hepatic neoplasm malignant non-resectable | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung adenocarcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to abdominal cavity | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pancreatic carcinoma non-resectable | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Parathyroid tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Ureteric cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral artery occlusion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral haematoma | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syringomyelia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Depression suicidal | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Major depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vaginal fistula | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Angioplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Aortic valve repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Aortic valve replacement | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Appendicectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Bunion operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Cardioversion | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Haemorrhoid operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Inguinal hernia repair | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intrathecal pump insertion | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Keratoplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Malignant tumour excision | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Radiotherapy to eye | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Salivary gland operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Scoliosis surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Spinal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Vasodilation procedure | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
| Circulatory collapse | Vascular disorders | MedDRA | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Choroidal neovascularisation | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.