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 @ 11:31 PM
Ignite Modification Date: 2025-12-25 @ 9:19 PM
NCT ID: NCT01934556
Description: None
Frequency Threshold: 5
Time Frame: 2 years
Study: NCT01934556
Study Brief: A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Monthly Monthly Cohort (30 eyes) - Study eyes will receive intravitreal injections of 0.3 mg ranibizumab every 4 weeks for 24 months. Ranibizumab 0.3 mg intravitreal injection 1 None 11 30 30 30 View
TREX (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits. At the fourth visit (Week 12), if the central foveal thickness is ≤ 325 μm then the eye will receive 0.3 mg ranibizumab and begin the extension phase of the study. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD (Spectral Domain)-OCT criteria. Treatment is rendered at every visit. The time between visits is individualized based on each subject's response to treatment. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. Ranibizumab 0.3 mg intravitreal injection 5 None 30 60 60 60 View
GILA (60 eyes) - Monthly intravitreal injections of 0.3 mg ranibizumab for four visits combined with guided laser photocoagulation to all microaneurysms in the area of DME at visit 2 (Week 4) and then again every 3 months, if leakage is present on fluorescein angiography. If the central foveal thickness is ≤ 325 μm at visit 4 (Week 12), eyes will receive 0.3 mg ranibizumab and the extension phase will begin. For all subsequent visits in the extension phase, appropriate changes to the treatment interval with 0.3 mg ranibizumab (i.e. extend, maintain, reduce) will be made based on pre-specified SD-Optical coherence tomography criteria. If the central foveal thickness is \> 325 μm at week 12, then the patient will continue to receive monthly intravitreal injections of 0.3 mg ranibizumab and possible guided laser every 3 months until the central foveal thickness is ≤ 325 μm. Once the central foveal thickness is ≤ 325 μm, then the study eye will begin the extension phase of the study. 2 None 46 60 60 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vitreous Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders Vitreous Hemorrhage View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders Myocardial Infarctio View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders Angina Pectoris View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders Cardiac Arrhythmia View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders Cardiomyopathy View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders Heart Failure View
Coronary Artery Disease SYSTEMATIC_ASSESSMENT Cardiac disorders Coronary Art Disease View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders Pericardial Effusion View
Gallstones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Gallstones View
Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Hematoma View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Thrombocytopenia View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders Allergy View
Appendicitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Appendicitis View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations GI Infection View
Parotitis SYSTEMATIC_ASSESSMENT Infections and infestations Parotitis View
Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations Resp Infection View
Skin/Soft Tissue Infection SYSTEMATIC_ASSESSMENT Infections and infestations Skin/ST Infection View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations UTI View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Elevated Creatinine View
Hyperammonemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Hyperammonemia View
Hypo/Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders Hypo/Hyperglycemia View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Arthritis View
Fractured Bone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Fractured Bone View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Pain View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer View
Lung Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer View
Prostate Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer View
Cranial Nerve Palsy SYSTEMATIC_ASSESSMENT Nervous system disorders Cranial Nerve Palsy View
Cerebrovascular Accident SYSTEMATIC_ASSESSMENT Nervous system disorders CVA View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders Syncope View
Transient Ischemic Attack SYSTEMATIC_ASSESSMENT Nervous system disorders TIA View
Urolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders Kidney Stones View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders Renal Failure View
Acute Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Resp Failure View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Dyspnea View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Pneumonia View
Orthostatic Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders Orth Hypotension View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders Hypertension View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Blurred Vision/Vision Loss SYSTEMATIC_ASSESSMENT Eye disorders Blurred Vision View
Cataract Progression SYSTEMATIC_ASSESSMENT Eye disorders Cataract Progression View
Chalazion SYSTEMATIC_ASSESSMENT Eye disorders Chalazion View
Elevated Intraocular Pressure SYSTEMATIC_ASSESSMENT Eye disorders Elevated IOP View
Eye Discomfort/Discharge SYSTEMATIC_ASSESSMENT Eye disorders Eye Pain View
Eyelid Swelling SYSTEMATIC_ASSESSMENT Eye disorders Eyelid Swelling View
Secondary Cataract SYSTEMATIC_ASSESSMENT Eye disorders Secondary Cataract View
Vitreous Floaters SYSTEMATIC_ASSESSMENT Eye disorders Floaters View
Punctate Keratitis SYSTEMATIC_ASSESSMENT Eye disorders Punctate Keratitis View
Vitreous Hemorrhage SYSTEMATIC_ASSESSMENT Eye disorders Vitreous Hemorrhage View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders Myocardial Infarctio View
Angina Pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders Angina Pectoris View
Cardiac Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders Arrhythmia View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders Heart Failure View
Peripheral Edema SYSTEMATIC_ASSESSMENT Vascular disorders Peripheral Edema View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Diarrhea View
Gallstones SYSTEMATIC_ASSESSMENT Hepatobiliary disorders Gallstones View
Esophageal Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Esophageal Reflux View
Poor Dentition SYSTEMATIC_ASSESSMENT General disorders Poor Dentition View
Throat Irritation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Throat Irritation View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Anemia View
Allergy SYSTEMATIC_ASSESSMENT Immune system disorders Allergy View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations Fever View
Gastrointestinal Infection SYSTEMATIC_ASSESSMENT Infections and infestations GI Infection View
Skin Infection SYSTEMATIC_ASSESSMENT Infections and infestations Skin Infection View
Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations Resp Infection View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations Sinusitis View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations UTI View
Fatigue SYSTEMATIC_ASSESSMENT General disorders Fatigue View
Hypo/Hyperglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders Hypo/Hyperglycemia View
Hyperlipidemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Hyperlipidemia View
Hypo/Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Hypo/Hyperkalemia View
Testosterone Deficiency SYSTEMATIC_ASSESSMENT Endocrine disorders Testosterone Def View
Vitamin D Deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders Vit D Deficiency View
Fractured Bone SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Fractured Bone View
Musculoskeletal Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Pain View
Skin Burn SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders Skin Burn View
Colon Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer View
Depression/Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders Depression/Anxiety View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders Dizziness View
Headache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Headache View
Insomnia SYSTEMATIC_ASSESSMENT General disorders Insomnia View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders Paresthesia View
Renal Insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders Renal Insufficiency View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Cough View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Pneumonia View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders Hypertension View