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 @ 2:16 AM
Ignite Modification Date: 2025-12-26 @ 12:46 AM
NCT ID: NCT02450760
Description: Does not differ
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT02450760
Study Brief: Connected Health Blood Pressure Monitoring In Stroke and TIA 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
Control Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. If subjects miss blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. Subjects will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence 0 None 0 15 0 15 View
Social Incentive Subjects will take their blood pressure twice daily using the provided Withings blood pressure cuff. Subjects in this arm will also identify a social supporter who may help subjects adhere to daily blood pressure readings. If the subject misses blood pressure readings, they will receive automated alerts reminding them to take their blood pressure. The identified social supporter will also receive these alerts, with the expectation that the social supporter will remind the subject to take their blood pressure. Both the subject and the social supporter will also receive weekly emails with their blood pressure data for the week. Social incentive: Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence 0 None 0 18 0 18 View
Serious Events(If Any):
Other Events(If Any):