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 @ 11:33 PM
Ignite Modification Date: 2025-12-25 @ 9:22 PM
NCT ID: NCT02546856
Description: None
Frequency Threshold: 5
Time Frame: From Baseline to 6 months
Study: NCT02546856
Study Brief: Safety and Effectiveness of Drug up Titration by Nurses Specialized in Heart Failure (HF) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Heart Failure (HF) Cardiologist Up-titration Active Comparator:Cardiologist decides dosage with nursing clinical and educational support. HF cardiologist up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines HF cardiologist up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% Patients, following a protocol based on 2012 ESC HF guidelines 4 None 11 145 20 145 View
HF Nurse Up-titration Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. HF nurse up-titration: Up-titration of Beta-Blocker (BB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 European Society of Cardiology (ESC) HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Angiotensin Converting Enzyme Inhibitor (ACEI) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Angiotensin II Receptor Blocker (ARB) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support HF nurse up-titration: Up-titration of Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure " De Novo" EF≤ 40% patients. Protocol based on 2012 ESC HF guidelines. Cardiologist prescription and support 3 None 2 144 22 144 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
hospitalizations due to cardiovascular cause SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
heart rate <50 bpm SYSTEMATIC_ASSESSMENT Cardiac disorders None View
symptomatic hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View