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 |
|---|---|---|---|---|---|---|---|---|
| PSMA PET/CT | PET/CT with Gallium-68 labeled PSMA-HBED-CC: Subjects will have one visit during which they will undergo a PET/CT after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. PET/CT occurs if a) an MRI can't be performed concurrently; or b) the participant already had an MRI of the abdomen/pelvis or pelvis only. | 0 | None | 0 | 1 | 0 | 1 | View |
| PSMA Multiple PET/MRI | Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC: Subjects will be invited to participate in two visits within two years, the second being an optional visit. During each visit, subjects will undergo a PET/MRI after being injected with the study drug, Gallium-68 labeled PSMA-HBED-CC. This arm will be restricted to subjects who plan to undergo focal therapy. | 0 | None | 0 | 0 | 0 | 0 | View |
| PSMA PET/MRI Scan | These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent PSMA PET and MRI from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection. | 0 | None | 0 | 273 | 0 | 273 | View |
| MRI Scan | These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent PSMA PET and MRI from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection. | 0 | None | 0 | 273 | 0 | 273 | View |