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 @ 2:13 PM
Ignite Modification Date:
2025-12-25 @ 12:52 PM
NCT ID:
NCT00964795
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00964795
Study Brief:
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (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 |
|---|---|---|---|---|---|---|---|---|
| Open-label Intravitreal Aflibercept Injection | Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above. | None | None | 105 | 323 | 102 | 323 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Coagulopathy | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Haemorrhagic Anaemia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Iron Deficiency Anaemia | None | Blood and lymphatic system disorders | MedDRA 14.0 | View |
| Acute Myocardial Infarction | None | Cardiac disorders | MedDRA 14.0 | View |
| Angina Pectoris | None | Cardiac disorders | MedDRA 14.0 | View |
| Arrhythmia | None | Cardiac disorders | MedDRA 14.0 | View |
| Atrial Fibrillation | None | Cardiac disorders | MedDRA 14.0 | View |
| Bundle Branch Block Right | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac Arrest | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac Failure Acute | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiac Failure Congestive | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiogenic Shock | None | Cardiac disorders | MedDRA 14.0 | View |
| Cardiomyopathy | None | Cardiac disorders | MedDRA 14.0 | View |
| Coronary Artery Disease | None | Cardiac disorders | MedDRA 14.0 | View |
| Myocardial Infarction | None | Cardiac disorders | MedDRA 14.0 | View |
| Myocardial Rupture | None | Cardiac disorders | MedDRA 14.0 | View |
| Pericarditis | None | Cardiac disorders | MedDRA 14.0 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 14.0 | View |
| Ventricular Tachycardia | None | Cardiac disorders | MedDRA 14.0 | View |
| Appendix Disorder | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Colitis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Colitis Ischaemic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Dysphagia | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Gastrointestinal Angiodysplasia Haemorrhagic | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Hiatus Hernia | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Ileus | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Impaired Gastric Emptying | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Intestinal Obstruction | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Large Intestine Perforation | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Lower Gastrointestinal Haemorrhage | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Pancreatitis | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Asthenia | None | General disorders | MedDRA 14.0 | View |
| Chest Pain | None | General disorders | MedDRA 14.0 | View |
| Device Dislocation | None | General disorders | MedDRA 14.0 | View |
| Multi-Organ Failure | None | General disorders | MedDRA 14.0 | View |
| Non-Cardiac Chest Pain | None | General disorders | MedDRA 14.0 | View |
| Biliary Dyskinesia | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Cholecystitis Acute | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Hepatic Haemorrhage | None | Hepatobiliary disorders | MedDRA 14.0 | View |
| Anaphylactic Reaction | None | Immune system disorders | MedDRA 14.0 | View |
| Abdominal Abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Appendicitis | None | Infections and infestations | MedDRA 14.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 14.0 | View |
| Bronchitis Viral | None | Infections and infestations | MedDRA 14.0 | View |
| Cellulitis | None | Infections and infestations | MedDRA 14.0 | View |
| Clostridium Difficile Colitis | None | Infections and infestations | MedDRA 14.0 | View |
| Escherichia Urinary Tract Infection | None | Infections and infestations | MedDRA 14.0 | View |
| Gastroenteritis | None | Infections and infestations | MedDRA 14.0 | View |
| Gastroenteritis Norovirus | None | Infections and infestations | MedDRA 14.0 | View |
| Gastroenteritis Viral | None | Infections and infestations | MedDRA 14.0 | View |
| Pericolic Abscess | None | Infections and infestations | MedDRA 14.0 | View |
| Peritonitis | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia Bacterial | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia Respiratory Syncytial Viral | None | Infections and infestations | MedDRA 14.0 | View |
| Pneumonia Viral | None | Infections and infestations | MedDRA 14.0 | View |
| Pyelonephritis Acute | None | Infections and infestations | MedDRA 14.0 | View |
| Sepsis | None | Infections and infestations | MedDRA 14.0 | View |
| Septic Shock | None | Infections and infestations | MedDRA 14.0 | View |
| Urinary Tract Infection | None | Infections and infestations | MedDRA 14.0 | View |
| Urosepsis | None | Infections and infestations | MedDRA 14.0 | View |
| Accident | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Coronary Artery Restenosis | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Facial Bones Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Femoral Neck Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Gastrointestinal Anastomotic Leak | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Hip Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Humerus Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Pancreatic Leak | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Radius Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Road Traffic Accident | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Splenic Rupture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Upper Limb Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Wrist Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Blood Pressure Increased | None | Investigations | MedDRA 14.0 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Diabetes Mellitus Inadequate Control | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Hyponatraemia | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Malnutrition | None | Metabolism and nutrition disorders | MedDRA 14.0 | View |
| Arthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Back Pain | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Haemarthrosis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Osteoporotic Fracture | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Spinal Osteoarthritis | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Bone Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Breast Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Breast Cancer Recurrent | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Chronic Leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Chronic Myelomonocytic Leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Intraductal Proliferative Breast Lesion | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Invasive Ductal Breast Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Laryngeal Squamous Cell Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Lung Adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Oesophageal Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Rectal Adenocarcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Renal Cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Squamous Cell Carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Squamous Cell Carcinoma Of Lung | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | View |
| Carotid Artery Stenosis | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebral Haemorrhage | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebral Infarction | None | Nervous system disorders | MedDRA 14.0 | View |
| Cerebrovascular Accident | None | Nervous system disorders | MedDRA 14.0 | View |
| Convulsion | None | Nervous system disorders | MedDRA 14.0 | View |
| Embolic Stroke | None | Nervous system disorders | MedDRA 14.0 | View |
| Facial Neuralgia | None | Nervous system disorders | MedDRA 14.0 | View |
| Hemiplegia | None | Nervous system disorders | MedDRA 14.0 | View |
| Hypertensive Encephalopathy | None | Nervous system disorders | MedDRA 14.0 | View |
| Intracranial Haematoma | None | Nervous system disorders | MedDRA 14.0 | View |
| Ischaemic Stroke | None | Nervous system disorders | MedDRA 14.0 | View |
| Subarachnoid Haemorrhage | None | Nervous system disorders | MedDRA 14.0 | View |
| Syncope | None | Nervous system disorders | MedDRA 14.0 | View |
| Transient Ischaemic Attack | None | Nervous system disorders | MedDRA 14.0 | View |
| Major Depression | None | Psychiatric disorders | MedDRA 14.0 | View |
| Mental Status Changes | None | Psychiatric disorders | MedDRA 14.0 | View |
| Psychotic Disorder | None | Psychiatric disorders | MedDRA 14.0 | View |
| Calculus Ureteric | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Obstructive Uropathy | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Renal Failure Acute | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Renal Failure Chronic | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Ureteric Obstruction | None | Renal and urinary disorders | MedDRA 14.0 | View |
| Uterine Polyp | None | Reproductive system and breast disorders | MedDRA 14.0 | View |
| Acute Respiratory Failure | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Aspiration | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Chronic Obstructive Pulmonary Disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Laryngospasm | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pleural Effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Pulmonary Embolism | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Respiratory Arrest | None | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | View |
| Perivascular Dermatitis | None | Skin and subcutaneous tissue disorders | MedDRA 14.0 | View |
| Colectomy | None | Surgical and medical procedures | MedDRA 14.0 | View |
| Medical Device Removal | None | Surgical and medical procedures | MedDRA 14.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 14.0 | View |
| Retinal Haemorrhage | None | Eye disorders | MedDRA 14.0 | View |
| Angle Closure Glaucoma | None | Eye disorders | MedDRA 14.0 | View |
| Cataract | None | Eye disorders | MedDRA 14.0 | View |
| Glaucoma | None | Eye disorders | MedDRA 14.0 | View |
| Retinal Haemorrhage | None | Eye disorders | MedDRA 14.0 | View |
| Retinal Oedema | None | Eye disorders | MedDRA 14.0 | View |
| Visual Acuity Reduced | None | Eye disorders | MedDRA 14.0 | View |
| Device Dislocation | None | General disorders | MedDRA 14.0 | View |
| Endophthalmitis | None | Infections and infestations | MedDRA 14.0 | View |
| Corneal Abrasion | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Intraocular Pressure Increased | None | Investigations | MedDRA 14.0 | View |
| Femur Fracture | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | None | Gastrointestinal disorders | MedDRA 14.0 | View |
| Bronchitis | None | Infections and infestations | MedDRA 14.0 | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA 14.0 | View |
| Upper Respiratory Tract Infection | None | Infections and infestations | MedDRA 14.0 | View |
| Fall | None | Injury, poisoning and procedural complications | MedDRA 14.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | View |
| Hypertension | None | Vascular disorders | MedDRA 14.0 | View |
| Age-Related Macular Degeneration | None | Eye disorders | MedDRA 14.0 | View |
| Retinal Haemorrhage | None | Eye disorders | MedDRA 14.0 | View |
| Cataract | None | Eye disorders | MedDRA 14.0 | View |
| Conjunctival Haemorrhage | None | Eye disorders | MedDRA 14.0 | View |
| Posterior Capsule Opacification | None | Eye disorders | MedDRA 14.0 | View |
| Retinal Detachment | None | Eye disorders | MedDRA 14.0 | View |
| Retinal Haemorrhage | None | Eye disorders | MedDRA 14.0 | View |