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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Sub Study 1 Chronic Hep C Patients | Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Patients with liver disease who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge. | 0 | None | 0 | 19 | 0 | 19 | View |
| Sub Study III | Noninvasive Prediction of Portal Pressure with MR Elastography and DCE�\\MRI of the Liver and Spleen Description: Chronic liver disease patients who underwent HVPG measurement, MR elastography (MRE) and dynamic contrast�\\enhanced MRI (DCE�\\MRI) of the liver and spleen | 0 | None | 0 | 34 | 0 | 34 | View |
| Total Participants of the Substudies | Total participants of Sub Study 1, Sub Study II, and Sub Study III | 0 | None | 0 | 124 | 2 | 124 | View |
| Sub Study II | Arm/Group Title: Prospective Comparison of Magnetic Resonance Imaging to Transient Elastography and Serum Markers for Liver Fibrosis Detection Description: Chronic liver disease patients who underwent a multiparametric magnetic resonance imaging (MRI) protocol including diffusion�\\weighted imaging (DWI), dynamic contrast�\\enhanced (DCE)�\\MRI and magnetic resonance elastography (MRE) in comparison with transient elastography (TE) for liver fibrosis detection. | 0 | None | 0 | 60 | 2 | 60 | View |
| Sub Study 1 Health Volunteers | Quantitative Liver MRI Combining Phase Contrast Imaging, Elastography, and DWI: Assessment of Reproducibility and Postprandial Effect Description: Healthy volunteers who had portal vein (PV) flow parameters measured with phase contrast (PC) imaging, liver diffusion parameters measured with multiple b value diffusion-weighted imaging (DWI) and liver stiffness (LS) measured with MR elastography (MRE) in fasting conditions and after a meal challenge. | 0 | None | 0 | 11 | 0 | 11 | View |