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 @ 4:34 PM
Ignite Modification Date: 2025-12-25 @ 2:26 PM
NCT ID: NCT02079766
Description: Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug. Includes all subjects who received at least one dose of florbetapir or flortaucipir
Frequency Threshold: 1
Time Frame: End of study for AE reporting was 48 hours after the last study drug administration.
Study: NCT02079766
Study Brief: 18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Risk of CTE Subjects at high risk of developing CTE (former National Football League players) 0 None 0 29 11 29 View
Controls Former non-contact athletes 0 None 0 11 5 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View
diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.1 View
musculoskeletal discomfort SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 17.1 View
fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 17.1 View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.1 View