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:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
NCT ID:
NCT04679935
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events are reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum timeframe of approximately 52 weeks.
Study:
NCT04679935
Study Brief:
Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Brolucizumab 6 mg Loading | 3 x 4-weekly initial injections followed by an injection every 12 weeks | 0 | None | 5 | 25 | 23 | 25 | View |
| Brolucizumab 6 mg Non-loading | One initial injection followed by treatment every 12 weeks | 1 | None | 6 | 27 | 26 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye inflammation- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Iridocyclitis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal haemorrhage- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal neovascularisation- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal vasculitis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual acuity reduced- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Endophthalmitis- Study Eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Intraocular pressure increased- Study Eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Chromophobe renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | View |
| Hepatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | View |
| Ballismus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anterior chamber cell- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Blepharitis- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Cataract- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Cataract- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Chalazion- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctival haemorrhage- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctival hyperaemia- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctival irritation- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Conjunctivitis allergic- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal epithelial microcysts- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Corneal erosion- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Detachment of retinal pigment epithelium- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Dry eye- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eczema eyelids- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eczema eyelids- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Episcleritis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye inflammation- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye inflammation- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye irritation- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye pain- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Eye ulcer- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Foreign body sensation in eyes- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Macular oedema- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Macular oedema- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Neovascular age-related macular degeneration- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Neovascular age-related macular degeneration- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Ocular hyperaemia- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Posterior capsule opacification- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal aneurysm- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal aneurysm- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal cyst- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal exudates- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal exudates- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal haemorrhage- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal oedema- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal oedema- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinal vasculitis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Retinopathy hypertensive | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Scleritis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Subretinal fibrosis- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Subretinal fluid- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Subretinal fluid- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vision blurred- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual acuity reduced- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual acuity reduced- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Visual acuity reduced- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreal cells- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous detachment- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous floaters- Bilateral | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous floaters- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous haemorrhage- Fellow Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Vitreous opacities- Study Eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.0) | View |
| Tooth impacted | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.0) | View |
| Application site wound | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Injection site pain- Study Eye | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Retention cyst- Fellow Eye | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.0) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (27.0) | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Conjunctivitis- Study Eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Herpes virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Hordeolum- Study Eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Lyme disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Sialoadenitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.0) | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Bone contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Epicondylitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Expired product administered- Study Eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Intra-ocular injection complication- Fellow Eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Intra-ocular injection complication- Study Eye | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Ligament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Stress fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.0) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Intraocular pressure increased- Fellow Eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Intraocular pressure increased- Study Eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Vital dye staining cornea present- Study Eye | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.0) | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Jaw cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Muscle tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | View |
| Blepharal papilloma- Fellow Eye | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Restless legs syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (27.0) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.0) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (27.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.0) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.0) | View |
| Palmar erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.0) | View |