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 @ 12:45 AM
Ignite Modification Date: 2025-12-25 @ 10:59 PM
NCT ID: NCT02191267
Description: None
Frequency Threshold: 0
Time Frame: Through study completion, Subjects were assessed for adverse effects immediately following each scan (On Day 1 and Day 2) and again by telephone 72 hours following study participation. Thus, assessment for adverse events were made over over a 5-day period which included Days 1 and 2 of the study visit and a follow-up telephone assessment on Day 5.
Study: NCT02191267
Study Brief: Tau Imaging of 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
AD Dementia Group Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan. \[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain. \[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain. 0 None 0 4 0 4 View
Presumed CTE Group Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan. \[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain. \[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain. 0 None 0 19 0 19 View
Control Group Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan. \[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain. \[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):