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 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
NCT ID:
NCT05269966
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were reported from first dose of study treatment until Week 48, plus 8 weeks follow up, to a maximum timeframe of 56 weeks.
Study:
NCT05269966
Study Brief:
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
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 | Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment. Brolucizumab 6 mg was administered by Intravitreal (IVT) injections as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients received loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) was performed based on Best Corrected Visual Acuity (BCVA) and Optical Coherence Tomography (OCT) to assess whether the patient required q8w or q12w dosing. | 0 | None | 0 | 105 | 67 | 105 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| Conjunctival haemorrhage- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Conjunctival hyperaemia- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Eye irritation- Study 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 |
| Lacrimation increased- Fellow eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Lacrimation increased- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Macular scar- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Ocular hyperaemia- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal haemorrhage- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal pigment epithelial tear- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Retinal vasculitis- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Swelling of eyelid- 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 impairment- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Vitreous floaters- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Vitritis- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Conjunctivitis- Study eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.0) | View |
| Uveitis- Study eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (26.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.0) | View |
| Injection site pain- Study eye | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Instillation site lacrimation- Study eye | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Sensation of foreign body- Fellow eye | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.0) | View |
| Hyperglycaemia | 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 |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.0) | View |
| Cataract operation- Fellow eye | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.0) | View |
| Cataract operation- Study eye | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (26.0) | View |