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 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT03712904
Description:
Adverse events will be graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Frequency Threshold:
5
Time Frame:
The PI will follow adverse events with start dates occurring any time after informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. Up to approximately 6 months.
Study:
NCT03712904
Study Brief:
Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A. Stereotactic Body Radiation Therapy, Ziv-aflibercept | Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Stereotactic Body Radiation Therapy: Undergo radiation | 0 | None | 0 | 1 | 1 | 1 | View |
| B. Stereotactic Body Radiation Therapy, Ziv-aflibercept | Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity. Ziv-Aflibercept: Given IV | 1 | None | 1 | 2 | 2 | 2 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic Rhinitis - Grade 1 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | View |
| Atrial Fibrillation - Grade 3 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (Unspecified) | View |
| Bloating - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Blurred Vision - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Cardiac Myopathy - Grade 1 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Cataract - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Chronic Kidney Disease - Grade 1 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (5.0) | View |
| Coronary Artery Disease - Grade 1 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Dyspnea - Grade 1 | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Episcleritis - eye - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Erythma - face - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Eye Hemorrhage - Grade 2 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Eye Pain - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Fatigue - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Flashing lights - eye - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Floaters - Eye - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Focal dissection in right hepatic artery - Grade 1 | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Foreign body sensation - eye - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Hearing impairment - Grade 1 | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Hernia - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Hyperglycemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Hypertension - Grade 3 | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (5.0) | View |
| Impaired fasting glucose - Grade 1 | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (5.0) | View |
| Impaired Hearing - Grade 1 | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Hyperkalemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (5.0) | View |
| Left Eye Buckle - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Left eye superior arc worse - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Microcytic anemia - Grade 1 | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (5.0) | View |
| Myelodysplastic Syndrome - Grade 1 | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (5.0) | View |
| Nuclear sclerosis - both eyes - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Osteoarthritis - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Pain - Back - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Periorbital changes - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Peripheral sensory neuropathy - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | View |
| Photophobia - Grade 1 | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (5.0) | View |
| Redness - Eye - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Renal insufficiency - Grade 1 | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (5.0) | View |
| Retinal detachment - Grade 2 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Retinal detachment - Grade 3 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Right Eye Cystoid Macular Edema - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Spinal stenosis - lumbar region - Grade 1 | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | View |
| Subretinal Fluid - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Swelling - Eye - Grade 1 | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (5.0) | View |
| Tinnitus - Grade 1 | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (5.0) | View |
| Vision decreased - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |
| Visual field defect - Grade 1 | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (5.0) | View |