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 @ 5:55 PM
Ignite Modification Date: 2025-12-25 @ 3:19 PM
NCT ID: NCT04179968
Description: None
Frequency Threshold: 5
Time Frame: Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.
Study: NCT04179968
Study Brief: The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients With Suspected Prostate Cancer Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy 68Ga PSMA-11 injection: Injection of 68Ga PSMA-11 Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection 0 None 0 20 6 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea without emesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Maculopapular rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View