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: 2025-12-26 @ 10:58 AM
Ignite Modification Date: 2025-12-26 @ 10:58 AM
NCT ID: NCT01003106
Description: None
Frequency Threshold: 5
Time Frame: From Baseline to Month 36
Study: NCT01003106
Study Brief: Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BRVO Patients with Branch Retinal Vein Occlusion None None 17 42 37 42 View
CRVO Patients with Central Retinal Vein Occlusion None None 12 39 35 39 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection Requiring Hospitalization SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsening of Cataract/Cataract Surgery SYSTEMATIC_ASSESSMENT Eye disorders None View
Hospitalization for Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Vertebral Fracture/Surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Cerebrovascular event SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization for Septic Shock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Knee surgery SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vitreous Hemorrhage resulting in significant visual loss SYSTEMATIC_ASSESSMENT Eye disorders None View
Severe Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Kidney Surgery SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Trabulectomy SYSTEMATIC_ASSESSMENT Eye disorders None View
Severe Cheat pain/Acute Coronary Syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Colon Surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization due to multiple systemic diseases SYSTEMATIC_ASSESSMENT General disorders None View
Brain Surgery SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient global Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Serious Drug Allergy requiring Hospitalization SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Surgery for Macular Pucker SYSTEMATIC_ASSESSMENT Eye disorders None View
Hospitalization for Thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Parotid Gland Swelling SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pancreatic Mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Increased IOP SYSTEMATIC_ASSESSMENT Eye disorders None View
Tooth Extraction SYSTEMATIC_ASSESSMENT General disorders None View
Skin Lesion/Skin Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Common Cold/cough SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Worsening Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hernia Repair Surgery SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fall SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Vitreous Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders None View
Squamous Cell/Basal Cell Carcinoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Worsening Hypercholesterlemia SYSTEMATIC_ASSESSMENT General disorders None View
Foot Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Seasonal Allergy SYSTEMATIC_ASSESSMENT General disorders None View
Gout SYSTEMATIC_ASSESSMENT General disorders None View