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: 2025-12-25 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT02167594
Description: Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.
Frequency Threshold: 1.0
Time Frame: End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.
Study: NCT02167594
Study Brief: Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PSP Subjects Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan 0 None 0 20 2 20 View
CBD Subjects Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan 1 None 0 6 1 6 View
Healthy Volunteers Healthy volunteers receiving a flortaucipir PET scan 0 None 0 3 0 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (17.0) View
muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (17.0) View
asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA (17.0) View