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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:02 AM
NCT ID: NCT04474405
Description: Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection of florbetapir or flortaucipir. AEs occurring after study drug administration, but outside that window were not recorded in the database, unless considered attributable to study drug injection. MRI/Amyloid extension cohort n=4 represents only those subjects receiving florbetapir PET scans.
Frequency Threshold: 0.5
Time Frame: End of study for AE reporting was 48 hours after the last study drug administration.
Study: NCT04474405
Study Brief: Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Whole Body PET Scan Subjects receiving a whole body PET scan after flortaucipir administration 0 None 0 9 3 9 View
Brain PET Scan (AD Subjects) AD subjects receiving a flortaucipir and florbetapir PET scan 0 None 0 4 0 4 View
Brain PET (YCN Subjects) Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan 0 None 0 4 1 4 View
Brain PET (OCN Subjects) Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan 0 None 0 4 0 4 View
MRI and Amyloid Extension Cohort Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 0 None 0 4 0 4 View
Brain PET (MCI Subjects) Mild cognitive impairment (MCI) subjects receiving a florbetapir and 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
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.1) View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.1) View
musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.1) View