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 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
NCT ID:
NCT00530504
Description:
None
Frequency Threshold:
0
Time Frame:
30 Days
Study:
NCT00530504
Study Brief:
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Intervention | PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection. | None | None | 553 | 1500 | 258 | 1500 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood And Lymphatic System Disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Ear And Labyrinth Disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Eye disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Gastrointestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| General Disorders And Administrative Site Conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Hepatobiliary disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.1) | View |
| Immune System Disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (14.1) | View |
| Infections And Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Injury, Poisoning And Procedural Complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Metabolism And Nutrition Disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Musculoskeletal And Connective Tissue Disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | View |
| Nervous System Disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Psychiatric Disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Renal And Urinary Disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Respiratory, Thoracic And Mediastinal Disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Skin And Subcutaneous Tissue Disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Surgical And Medical Procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.1) | View |
| Vascular Disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood And Lymphatic System Disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (14.1) | View |
| Cardiac disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (14.1) | View |
| Ear And Labyrinth Disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (14.1) | View |
| Eye Disorders | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (14.1) | View |
| Gastrointestinal Disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (14.1) | View |
| General Disorders And Administrative Site Conditions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (14.1) | View |
| Hepatobiliary Disorders | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (14.1) | View |
| Immune System Disorders | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (14.1) | View |
| Infections And Infestations | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (14.1) | View |
| Injury, Poisoning And Procedural Complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (14.1) | View |
| Investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (14.1) | View |
| Metabolism And Nutrition Disorders | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (14.1) | View |
| Musculoskeletal And Connective Tissue Disorders | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | View |
| Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | View |
| Nervous System Disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (14.1) | View |
| Psychiatric Disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (14.1) | View |
| Renal And Urinary Disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (14.1) | View |
| Reproductive System And Breast Disoders | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (14.1) | View |
| Respiratory, Thoracic And Mediastinal Disorders | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | View |
| Skin And Subcutaneous Tissue Disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (14.1) | View |
| Surgical And Medical Procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (14.1) | View |
| Vascular Disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (14.1) | View |