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 @ 8:03 PM
Ignite Modification Date: 2025-12-25 @ 5:36 PM
NCT ID: NCT04307004
Description: None
Frequency Threshold: 0
Time Frame: 2 weeks.
Study: NCT04307004
Study Brief: Evaluating Novel Approaches for Estimating Awake and Sleep Blood Pressure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Home Blood Pressure Monitoring (HBPM) Before Ambulatory Blood Pressure Monitoring (ABPM) During visit 2, participants underwent one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) before undergoing 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) in visit 3. 0 None 0 324 244 324 View
Ambulatory Blood Pressure Monitoring (ABPM) Before Home Blood Pressure Monitoring (HBPM) During visit 2, participants underwent 24 hours of Ambulatory Blood Pressure Monitoring (Microlife WatchBP O3) before undergoing one night of Home Blood Pressure Monitoring (Microlife WatchBP Home N) in visit 3. 0 None 0 330 228 330 View
Attended Before Unattended BP During visit 1, participants' clinic blood pressure was measured three times attended (i.e., in the presence of a technician) and then three times unattended (i.e., in the absence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times unattended and then three times attended. 0 None 0 326 0 326 View
Unattended Before Attended BP During visit 1, participants' clinic blood pressure was measured three times unattended (i.e., in the absence of a technician) and then three times attended (i.e., in the presence of a technician) using the Microlife WatchBP Office AFIB device. At visit 2, clinic blood pressure was measured three times attended and then three times unattended. 0 None 0 328 0 328 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Brusing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Discomfort SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Heavy to wear monitor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View