Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
NCT ID:
NCT03846193
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events are reported from the single dose of study medication administration until end of study treatment plus 240 weeks post treatment, up to a maximum timeframe of approximately 240 weeks.
Study:
NCT03846193
Study Brief:
FOCUS: A Phase I/II First in Human Study to Evaluate the Safety and Efficacy of GT005 Administered in Subjects With Dry AMD
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| GT005 5E10 vg Via Transvitreal Procedure | GT005 5E10 vg via Transvitreal Procedure | 3 | None | 6 | 10 | 10 | 10 | View |
| GT005 2E11 vg Via Transvitreal Procedure | GT005 2E11 vg via Transvitreal Procedure | 0 | None | 4 | 15 | 15 | 15 | View |
| GT005 5E10 vg With Orbit Subretinal Delivery System | GT005 5E10 vg with Orbit Subretinal Delivery System | 0 | None | 0 | 3 | 3 | 3 | View |
| GT005 2E11 vg With Orbit Subretinal Delivery System | GT005 2E11 vg with Orbit Subretinal Delivery System | 0 | None | 5 | 22 | 22 | 22 | View |
| Overall | Overall | 4 | None | 17 | 56 | 54 | 56 | View |
| GT005 2E10 vg Via Transvitreal Procedure | GT005 2E10 vg via Transvitreal Procedure | 1 | None | 2 | 6 | 4 | 6 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (26.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Joint dislocation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Breast cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Lymphatic system neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Oesophageal carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Pneumothorax spontaneous | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Peripheral artery aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.0) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Aortic valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Diastolic dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (26.0) | View |
| Corneal dystrophy - Fellow eye | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (26.0) | View |
| Corneal dystrophy - Study eye | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (26.0) | View |
| Ear pruritus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (26.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (26.0) | View |
| Goitre | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (26.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (26.0) | View |
| Anterior chamber cell - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Blepharitis - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Blepharitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Cataract - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Cataract - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Central vision loss - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Chalazion - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Charles Bonnet syndrome - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Charles Bonnet syndrome - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Choroidal haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Choroidal neovascularisation - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Choroidal neovascularisation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Conjunctival deposit - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Conjunctival haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Conjunctival hyperaemia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Corneal oedema - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Dacryostenosis acquired - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Diplopia - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Diplopia - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Dry eye - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Dry eye - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eye discharge - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eye pain - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eye pain - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eye pruritus - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eyelid irritation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eyelid ptosis - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eyelid ptosis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Foreign body sensation in eyes - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Glaucoma - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Glaucoma - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Iridocyclitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Keratitis - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Macular hole - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Neovascular age-related macular degeneration - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Neovascular age-related macular degeneration - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Ocular discomfort - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Ocular hypertension - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Ocular hypertension - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Optic disc haemorrhage - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Optic disc haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Periorbital oedema - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Posterior capsule opacification - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Posterior capsule opacification - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal aneurysm rupture - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal depigmentation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal haemorrhage - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal haemorrhage - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal pigmentation - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal pigmentation - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal tear - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Vision blurred - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Vision blurred - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual acuity reduced - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual acuity reduced - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual field defect - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual field defect - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual impairment - Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Visual impairment - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Vitreous floaters - Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Hiatus hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Intestinal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Intra-abdominal haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Oesophageal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Oesophageal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Adverse drug reaction | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Polyp | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Vessel puncture site bruise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (26.0) | View |
| Hepatic cyst | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (26.0) | View |
| Drug hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (26.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis - Fellow eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis - Study eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis bacterial - Fellow eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis bacterial - Study eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis viral - Fellow eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Conjunctivitis viral - Study eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Gastroenteritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Hordeolum - Fellow eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Staphylococcal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Viral sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Corneal abrasion - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Eye contusion - Fellow eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Foreign body in eye - Fellow eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Post procedural discomfort - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Procedural pain - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Scrotal haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Skin injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Skin wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Suture related complication - Study eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood bicarbonate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood cholesterol increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood folate decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Coronavirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Heart rate irregular | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Intraocular pressure increased - Fellow eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Intraocular pressure increased - Study eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Lipids increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Neutrophil count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Protein C increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Protein total decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| White blood cell count increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (26.0) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Iron deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Vitamin B12 deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Exostosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Intervertebral disc degeneration | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Spinal stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Trigger finger | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Adenoma benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Benign neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Keratoacanthoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Sweat gland tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | View |
| Aphasia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Carotid artery stenosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Cerebral artery thrombosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Cluster headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Meralgia paraesthetica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Ophthalmic migraine - Fellow eye | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Ophthalmic migraine - Study eye | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Post herpetic neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Vertebral artery occlusion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (26.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (26.0) | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (26.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (26.0) | View |
| Breast mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (26.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Haemoptysis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Sinus congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Upper-airway cough syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Haemosiderin stain | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Panniculitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Precancerous skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Rosacea | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Stasis dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Poor peripheral circulation | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Vein disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |
| Venous hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.0) | View |