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 |
|---|---|---|---|---|---|---|---|---|
| Patients With a Suspected Cerebral Glioma on Standard of Care MRI | Participants was a suspected cerebral glioma on standard of care imaging that are enrolled into the study had an \[18F\]FPIA PET-MRI scan performed at Imanova Limited on a Signa™ 3.0 T scanner. All participants enrolled into the study subsequently underwent a biopsy or surgical resection as part of their routine clinical care. Tissue obtained post-procedure (surgical resection/biopsy) to determine tumour grade and perform metabolomics, genomics, and proteomics. PET-MRI Protocol: Subjects received a single I.V bolus injection of \[18F\]FPIA followed by a saline flush. A single dose of \[18F\]FPIA (maximum 370MBq) was administered followed by a whole brain dynamic PET-MRI scan over 66 minutes. During the MRI sequences, the patients received an additional I.V bolus of Gadolinium contrast-medium administered through a peripheral venous cannula. MRI: Sequences for attenuation correction of PET data (DIXON, zero-TE), volumetric T1-weighted images (pre- and post-contrast administration), volumetric T2, dynamic susceptibility contrast perfusion (DSC) and dynamic contrast enhanced perfusion (DCE). * Maximum Injected Activity: 370MBq * Conversion Factor (mSv/MBq): 0.0187 * Total Effective Dose (mSv)/patient: 6.9 mSv The total effective dose for each patient in this study is 6.9 mSv. There is no ionising radiation from the MR component of the study. | 0 | None | 0 | 10 | 0 | 10 | View |