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: 2025-12-26 @ 2:39 PM
Ignite Modification Date: 2025-12-26 @ 2:39 PM
NCT ID: NCT01588106
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01588106
Study Brief: Evaluation of CONTOUR® USB BGMS on Glycaemic Control in Insulin-treated Diabetic 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
Test Group- CONTOUR Next USB Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects' blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline. None None 0 78 13 78 View
Control Group- Standard CONTOUR Subjects used the standard CONTOUR device. Subjects' blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline. None None 1 76 9 76 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
severe thrombosis of the portal vein None Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycaemia None Metabolism and nutrition disorders None View