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 @ 5:25 PM
Ignite Modification Date:
2025-12-25 @ 3:00 PM
NCT ID:
NCT01178268
Description:
None
Frequency Threshold:
0
Time Frame:
2 Years
Study:
NCT01178268
Study Brief:
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) China: Post-Approval Randomized Control Trial (RCT)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| XIENCE V EECSS | Patients who will receive this stent. XIENCE V EECSS: Patients who will receive this stent. | None | None | 53 | 360 | 32 | 360 | View |
| CYPHER SELECT PLUS SECSS | Patients who will receive this stent. CYPHER SELECT PLUS SECSS: Patients who will receive this stent. | None | None | 24 | 120 | 14 | 120 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Atrioventricular Block (AVB) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Creatine kinase MB (CK-MB) increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Coronary Dissection | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Coronary Heart Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Fibrillation Atrial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Gastric Ulcer With Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Gastrointestinal Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Hear Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Melena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Non-Targeted Vessel Revascularization | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Restenosis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Revascularization | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Subarachnoid Hemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 10.0 | View |
| Target Lesion Revascularization | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Non-Target Vascular Stenosis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Thrombocytopenic Purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 10.0 | View |
| Respiratory Fail, Chronic Bronchitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |
| Unstable Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Upper Gastrointestinal Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Vascular Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 10.0 | View |
| Extrasystole; Fibrillation Atrial | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Coronary heart disease (CHD), Coronary Revascularization | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Liver Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | View |
| Paroxysmal Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Target Vessel Revasculization | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Non-Target Vessel Restenosis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Chest Distress Because Of Air Pollution | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Chest Distress Occasionally | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Chest Pain Happens More Frequently | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Chest Tightness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Creatine kinase-MB (CK-MB0 Increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Coronary Artery Disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Cardiac troponin T increased (cTnI) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Cardiac troponin T of Post-Procedure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Melena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Myocardial infarction (MI) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 10.0 | View |
| Peri-procedural PCI and MI | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Premature Beat | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| The Cardiac Enzyme Is Higher | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Abnormal troponin I (TnI) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Troponin I (TnI) Increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Troponin I (TnI) Increase Significantly | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Troponin I (TnI) Of Post Procedure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Troponin T (TnT) of Post Procedure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 10.0 | View |
| Vessel Interlayer | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Breathing Difficulty | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 10.0 | View |
| Complication of percutaneous coronary intervention (PCI) Procedure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 10.0 | View |
| Gastrorrhagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 10.0 | View |
| Nasal Bleeding | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | View |