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 @ 1:33 AM
Ignite Modification Date: 2025-12-25 @ 11:47 PM
NCT ID: NCT03761394
Description: The definition of adverse event and/or serious adverse event used in this study was adapted from the clinicaltrials.gov definitions. The study principal investigator and data safety monitor were promptly notified of all adverse and serious adverse events and were asked for guidance on what action should be taken. All adverse events and serious adverse events were recorded in REDCap, a data collection tool, and also to the UMass Chan IRB
Frequency Threshold: 0
Time Frame: The adverse event data were monitored at baseline, at 14 days, and the 30 additional day follow-up for a total of approximately 44 days. Patient 1 - Serious adverse event occurred during the 14-day period. Patient 2 - Serious adverse event occurred during the 14-day period. Patient 3 - Serious adverse event occurred during the 14-day period. Patient 4 - Serious adverse event occurred during the 30-day extended period.
Study: NCT03761394
Study Brief: Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Group for Extended Use 30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor. Testing Devices: Pulsewatch system testing application on smartphone with smartwatch. Kardia Mobile by AliveCor: Mobile ECG device for comparison of testing devices during the extended use period. 0 None 1 57 0 57 View
Control Group for Extended Use No device usage for 30-days following completion of the original 14-day period. 0 None 0 58 0 58 View
Intervention Group Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period. Testing Devices: Pulsewatch system testing application on smartphone with smartwatch. Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices. 0 None 1 90 1 90 View
Control Group Only Cardea Solo device by Cardiac Insight for 14-day period. Cardea Solo by Cardiac Insight: Gold-standard cardiac monitor for comparison of testing devices. 0 None 2 30 3 30 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest Pain and hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Myocardial infarction and hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin irritation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View