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 @ 11:05 PM
Ignite Modification Date: 2025-12-25 @ 8:36 PM
NCT ID: NCT03919669
Description: The subjects received a phone call within 4 days from the study team for the purpose of ascertaining their wellbeing and information on adverse events that occur within 24 hours after the scan. If any adverse events were discovered, a clinician continued to follow up with the subject until resolved.
Frequency Threshold: 0
Time Frame: Given that this longitudinal study involves procedures that will occur at 6-12 month intervals and does not include chronic treatment with an investigational agent, adverse events (AEs) and serious adverse events (SAEs) were captured during the study visit before and after PiB and MK6240 scans, within 24 hours after the scan. Adverse events were monitored from signing the informed consent form through study completion, on average 2.5 years.
Study: NCT03919669
Study Brief: A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mild Cognitive Impairment All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240 0 None 0 8 0 8 View
Dementia All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240 0 None 0 13 3 13 View
Healthy Volunteer All subjects will complete PET imaging sessions evaluating the tau PET radioligand \[18F\]MK-6240 at baseline, as well as at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points. All Subjects: All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (Unspecified) View
Infusion Site Extravasation SYSTEMATIC_ASSESSMENT General disorders CTCAE (Unspecified) View