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 @ 5:05 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT01788150
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01788150
Study Brief: Safety and Efficacy Study of the Svelte Drug-Eluting Coronary Stent Delivery System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Svelte Drug-Eluting Coronary Stent Coronary Stenting Coronary Stenting 0 None 21 108 36 108 View
Medtronic Resolute Integrity Drug-Eluting Stent Coronary Stenting Coronary Stenting 0 None 8 51 14 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia None Cardiac disorders None View
Cardiac decompensation None Cardiac disorders None View
HYperthyroidism None Endocrine disorders None View
GI Bleed None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Local Infection None Infections and infestations None View
Fainting/Syncope/Vasovagal Reaction None Nervous system disorders None View
Bronchitis None Respiratory, thoracic and mediastinal disorders None View
Other respiratory None Respiratory, thoracic and mediastinal disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Renal Failure/Insufficiency None Renal and urinary disorders None View
Atypical Chest Pain None General disorders None View
Fever/Pyrexia None Immune system disorders None View
Chest pain wihtout cardiac enzyme elevation None General disorders None View
Endometrium Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Black-out after drinking wine None General disorders None View
Carotid Stenosis None Vascular disorders None View
Silent Ischemia None Cardiac disorders None View
Claudication None Vascular disorders None View
Restenosis None Vascular disorders None View
Depression None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
MI None Cardiac disorders None View
Elevated cardiac enzymes None Cardiac disorders None View
Dissection None Vascular disorders None View
Atypical Chest pain None General disorders None View