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 @ 10:42 PM
Ignite Modification Date: 2025-12-25 @ 8:12 PM
NCT ID: NCT02577835
Description: The following adverse events were collected: 1. All-Cause Mortality: the occurrence of death due to any cause (cardiovascular and non cardiovascular) 2. Serious Adverse Events: included nonfatal events (hospitalization) due to transient ischemic attack or stroke (ischemic or hemorragic), myocardial infarction, angina pectoris, or coronary revascularization, heart failure, peripheral vascular disease, renal failure. 3. Other Adverse Events: not applicable for this study
Frequency Threshold: 0
Time Frame: 4.2 years
Study: NCT02577835
Study Brief: International Registry for Ambulatory Blood Pressure and Arterial Stiffness Telemonitoring
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hypertensive Patients No intervention. Patients will be sumbitted to standard tests required for hypertension management, including ambulatory blood pressure monitoring, and pharmacologically treated according to recommendations of international guidelines. The registry will include data from subjects fulfilling the inclusion criteria and whose data are contained in existing databases collected by the participating centers and who are regularly followed-up at the center. New subjects can be enrolled for this project, but they must be submitted to ambualtory blood pressure monitoring because it is required for evaluating their hypertension status, according to current recommendations. Ambulatory blood pressure monitoring: Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals. 24 None 80 591 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient Ischemic Attack (TIA) or stroke (ischemic or hemorragic) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial infarction, angina pectoris, or coronary revascularization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Peripheral vascular disease NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):