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 @ 1:41 PM
Ignite Modification Date: 2025-12-25 @ 12:37 PM
NCT ID: NCT02736695
Description: The participants in the healthy control arm did not receive the intervention and were not enrolled in the study. Adverse events were not collected on the healthy controls.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of informed consent through study completion, approximately 1 week.
Study: NCT02736695
Study Brief: Assessment of Hyperphosphorylated Tau PET Binding in Primary Progressive Aphasia and Frontotemporal Dementia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tau PET Scan, F-18 AV 1451 All subjects will receive a Tau PET scan. F-18 AV 1451: Tau binding agent 0 None 0 81 0 81 View
Healthy Controls Subjects from our NIH funded Mayo Clinic Study of Aging (U01 AG006786) who have completed the identical tau-PET protocol with AV-1451 and MRI and clinical protocols. These participants were not consented or enrolled in this study. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):