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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT01523704
Description: None
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT01523704
Study Brief: Safety and Efficacy Study of IPG Patient With Home Monitoring
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 Monitoring Group Patients assigned to HM Group(HM follow-up ONLY) will have Home Monitoring programmed ON. They will be seen in the office for device interrogations at the 3-month follow-up, and at 27 month follow-up. In the meanwhile the device status will be evaluated using HM only for the 9, 15 and 21 month scheduled follow-up. Patients will visit the hospital for device interrogation on 27 month final follow-up. BIOTRONIK Home Monitoring System: Home Monitoring system transfers implantable device's data to the main server via internet. 46 None 68 558 7 558 View
Control Patients assigned to Control Group (HM + Conventional In-office follow-up - Control group) will have HM programmed ON. In addition to HM, these patients will visit the hospital for device interrogation at 3, 9, 15, 21 and 27 month follow-ups. BIOTRONIK Home Monitoring System with In-office Follow-up 41 None 68 550 16 550 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
The number of the composite primary endpoint SYSTEMATIC_ASSESSMENT Cardiac disorders None View
The number of Stroke SYSTEMATIC_ASSESSMENT Vascular disorders None View
The number of Cardiovascular surgery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other safety events NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View