Adverse Events Module

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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 @ 11:52 AM
Ignite Modification Date: 2025-12-25 @ 11:53 AM
NCT ID: NCT01535261
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01535261
Study Brief: Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
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 0.5mg Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN None None 64 357 244 357 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hyphaema (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Hyphaema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal adhesions SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ophthalmic herpes zoster (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Limb traumatic amputation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Bladder transitional cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Renal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Brain hypoxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Aneurysm ruptured SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Angiopathy SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Diabetic vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Myopia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal ischaemia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Retinal vascular thrombosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal mass SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haemorrhagic ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Peripheral artery aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cataract (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal polyp haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Large intestine polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Scapula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Intraocular pressure increased (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Visual acuity tests abnormal (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blepharitis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Cataract (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eye pain (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular fibrosis (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular discomfort (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hypertension (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vision blurred (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous detachment (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Conjunctivitis (Study eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Intraocular pressure increased (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cataract (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Conjunctival haemorrhage (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Dry eye (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Eyelid oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Glaucoma (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Macular oedema (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hyperaemia (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Ocular hypertension (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Visual acuity reduced (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Vitreous floaters (Study eye) SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Injection site pain (Study eye) SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Conjunctivitis (Fellow untreated eye) SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Intraocular pressure increased (Study eye) SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View