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 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
NCT ID:
NCT04522167
Description:
Safety analysis was performed on all patients who received at least 1 injection of study medication in the study eye. Patients were analyzed according to the treatment they actually received in the study eye irrespective of their randomized treatment.
Frequency Threshold:
2
Time Frame:
All AEs reported until the final end of study visit at week 56 are included.
Study:
NCT04522167
Study Brief:
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With 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 |
|---|---|---|---|---|---|---|---|---|
| FYB203 (Proposed Aflibercept Biosimilar), Systemic AE | Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. In this column all systemic AEs by patient for the FYB203 group are given. | 4 | None | 17 | 215 | 56 | 215 | View |
| Eylea® (Aflibercept), Systemic AE | Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. In this column all systemic AEs by patient for the Eylea® group are given. | 1 | None | 23 | 218 | 46 | 218 | View |
| FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Study Eye | Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. In this column all ocular AEs by patient for the FYB203 group occurring in the study eye are given. | 0 | None | 2 | 215 | 44 | 215 | View |
| Eylea® (Aflibercept), Ocular AE, Study Eye | Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. In this column all ocular AEs by patient for the Eylea® group occurring in the study eye are given. | 0 | None | 2 | 218 | 49 | 218 | View |
| FYB203 (Proposed Aflibercept Biosimilar), Ocular AE, Fellow Eye | Patients will receive intravitreal (IVT) injections of FYB203 as detailed in the protocol. FYB203 (Proposed aflibercept biosimilar): Patients will receive 1 IVT injection of FYB203 in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 19 patients choose to get treatment for the fellow eye (from 1 to 6 injections). In this column all ocular AEs by patient for the FYB203 group occurring in the fellow eye are given. | 0 | None | 0 | 215 | 37 | 215 | View |
| Eylea® (Aflibercept), Ocular AE, Fellow Eye | Patients will receive intravitreal (IVT) injections of Eylea® as detailed in the protocol. Eylea® (Aflibercept): Patients will receive 1 IVT injection of Eylea® in the study eye only every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion. The fellow eye could be treated with Eylea®, which was allowed after Visit 3 and was to be separated by at least 14 days from study eye treatment. In this group, 20 patients choose to get treatment for the fellow eye (from 1 to 6 injections). In this column all ocular AEs by patient for the Eylea® group occurring in the fellow eye are given. | 0 | None | 3 | 218 | 32 | 218 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Colonic abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Gallbladder empyema | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Toxic shock syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Adenocarcinoma gastric | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Gallbladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Oesophageal carcinoma stage 0 | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Parathyroid tumour benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 23.0 Mixed | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v 23.0 Mixed | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v 23.0 Mixed | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v 23.0 Mixed | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v 23.0 Mixed | View |
| Glaucoma | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Iridocyclitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Neovascular age-related macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Retinal degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Rhegmatogenous retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Uveitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Abdominal adhesions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Diverticulum intestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Large intestinal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v 23.0 Mixed | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |
| Transient global amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |
| Intervertebral disc disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Rheumatoid arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Clavicle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v 23.0 Mixed | View |
| Ligament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v 23.0 Mixed | View |
| Nerve root injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v 23.0 Mixed | View |
| Diabetic metabolic decompensation | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v 23.0 Mixed | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v 23.0 Mixed | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v 23.0 Mixed | View |
| Biliary dilatation | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v 23.0 Mixed | View |
| Gallbladder disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v 23.0 Mixed | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v 23.0 Mixed | View |
| Pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v 23.0 Mixed | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v 23.0 Mixed | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v 23.0 Mixed | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v 23.0 Mixed | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v 23.0 Mixed | View |
| Corneal dystrophy | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v 23.0 Mixed | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v 23.0 Mixed | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v 23.0 Mixed | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Neovascular age-related macular degeneration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Visual acuity reduced | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v 23.0 Mixed | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v 23.0 Mixed | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v 23.0 Mixed | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v 23.0 Mixed | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v 23.0 Mixed | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v 23.0 Mixed | View |