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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
NCT ID:
NCT00576693
Description:
The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
Frequency Threshold:
5
Time Frame:
Mean length of follow-up was 2.4 years
Study:
NCT00576693
Study Brief:
Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intensive Medical Management Plus Stenting | intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl). intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia | None | None | 146 | 224 | 117 | 224 | View |
| Intensive Medical Management Alone | Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure \< 140 / 90 mm Hg (\< 130 / 80 if diabetic) and LDL \< 70 mg / dl) | None | None | 121 | 227 | 118 | 227 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ischemic Stroke in the Territory of Qualifying Symptomatic Artery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Ischemic Stroke Not in the Territory of the Qualifying Symptomatic Artery | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Symptomatic Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Intracranial Hematoma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Transient Ischemic Attack / Cerebral Infarct with Temporary Signs | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Study Protocol | View |
| Systemic Hemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | Study Protocol | View |
| Allergy / Immunology | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE (3.0) | View |
| Auditory / Ear | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | CTCAE (3.0) | View |
| Blood / Bone Marrow | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Cardiac Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Cardiac General | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Constitutional Symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Dermatology / Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (3.0) | View |
| Endocrine | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAE (3.0) | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Hepatobiliary / Pancreas | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (3.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Lymphatics | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Metabolic / Laaboratory | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Musculoskeletal / Soft Tissue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Neurology | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Ocular / Visual | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pulmonary / Upper Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Renal / Genitourinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Sexual / Reproductive | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (3.0) | View |
| Surgery / Intraoperative Injury | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAE (3.0) | View |
| Vascular | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Asymptomatic Intracranial Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Hemorrhage / Bleeding | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (3.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | Study Protocol | View |
| Pulmonary Embolus | SYSTEMATIC_ASSESSMENT | Vascular disorders | Study Protocol | View |
| Cerebral Venous Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | Study Protocol | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | Study Protocol | View |
| Complications of Acute Ischemia of a Limb or Internal Organ | SYSTEMATIC_ASSESSMENT | Vascular disorders | Study Protocol | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Systemic Hemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | Study Protocol | View |
| Metabolic / Laboratory | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Pulmonary / Upper Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | View |
| Transient Ischemic Attack / Cerebral Infarct with Temporary Signs | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Study Protocol | View |
| Cardiac General | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Musculoskeletal / Soft Tissue | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Neurology | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (3.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |