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 @ 5:19 AM
Ignite Modification Date: 2025-12-26 @ 4:26 AM
NCT ID: NCT05162027
Description: None
Frequency Threshold: 0
Time Frame: From the first dose of study drug/placebo up to 4 weeks after the last dose (a total of 16 weeks).
Study: NCT05162027
Study Brief: Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Erenumab-aooe Erenumab-aooe 70 mg/ml. Subcutaneous injection. Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other Name: Aimovig® Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe: Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. 0 None 0 1 1 1 View
Placebo Placebo. Subcutaneous injection.Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. Other name: Placebo Placebo: Administered once every 4 weeks/28 days at visit 1, visit 2 and visit 3 for a total of 3 cycles. 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View