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: 2025-12-25 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:29 PM
NCT ID: NCT03237858
Description: Manage-HF Phase II was not started, the study was closed after Phase I
Frequency Threshold: 0
Time Frame: Adverse Events were collected for all enrolled subjects from the time of consent until the last Phase I subject had completed their 12-month visit
Study: NCT03237858
Study Brief: Multiple Cardiac Sensors for the Management of Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MANAGE-HF Phase I MANAGE-HF Phase I was an open label, non-randomized single arm study 19 None 100 200 104 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulse Generator NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA Lead NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV Lead NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular-HF NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular-Non-HF NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-cardiovascular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pulse Generator NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA Lead NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RV Lead NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular-HF NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiovascular-Non-HF NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Non-cardiovascular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View