Adverse Events Module

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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:07 AM
NCT ID: NCT01958918
Description: AE additional description
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT01958918
Study Brief: Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet 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
Ranibizumab 0.5 mg Ranibizumab 0.5 mg 1 None 67 356 156 356 View
Aflibercept 2 mg Aflibercept 2 mg 3 None 74 356 156 356 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.1) View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.1) View
Microcytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.1) View
Splenomegaly SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (17.1) View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Stress cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Systolic dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (17.1) View
Hydrocele SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA (17.1) View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (17.1) View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (17.1) View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (17.1) View
Angle closure glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Iridocyclitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Ocular hypertension SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Retinal haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Retinal pigment epithelial tear SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Ulcerative keratitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Vitreous adhesions SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Duodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (17.1) View
Amaurosis fugax SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Detachment of macular retinal pigment epithelium SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Ectropion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Haematemesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Intestinal polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Portal hypertensive gastropathy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Varices oesophageal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (17.1) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Medical device site joint pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.1) View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Cholangitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (17.1) View
Abscess oral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Endophthalmitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Infectious pleural effusion SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Klebsiella sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Lip infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Liver abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Alcohol poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Sternal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Thoracic vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (17.1) View
Body temperature decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.1) View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.1) View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.1) View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.1) View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.1) View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (17.1) View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Cervical spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Anal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Gastrointestinal stromal tumour SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Penile cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Renal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (17.1) View
Akinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Brain stem stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Cerebellar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Cervical myelopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Formication SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Glossopharyngeal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Hyperkinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Lacunar infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Peripheral sensorimotor neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Vascular dementia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (17.1) View
Device breakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA (17.1) View
Emotional distress SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (17.1) View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Urethral dilatation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (17.1) View
Atrophic vulvovaginitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.1) View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA (17.1) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.1) View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.1) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.1) View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.1) View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (17.1) View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intraocular pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (17.1) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.1) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (17.1) View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Ocular hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (17.1) View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (17.1) View